IUGA 43rd Annual Meeting – Vienna, Austria, June 27-30, 2018

001

Is over active bladder independently associated with anxiety?

Lovatsis, D 1 ; Mutungi, S 2 ; Parrish, J 3 ; Maunder, R 1 ; Alarab, M 1 ; McDermott, C 1 ; Lemos, N 1

1: Sinai Health System and University of Toronto; 2: University of Toronto; 3: Sinai Health System

Introduction: Some psychiatric anxiety questionnaires include questions regarding urinary urgency and frequency but there is little controlled data to confirm an association between anxiety and overactive bladder (OAB). We tested this association using a control group of women with non-OAB lower urinary tract symptoms (LUTS).

Objective: If anxiety is independently associated with OAB, and if anxiety is a common finding in patients presenting to clinicians who care for patients with LUTS, then this study will highlight the need for caregivers to identify these patients, and thus ensure appropriate assessment and management of anxiety.

Methods: Ambulatory clinic patients referred to a tertiary urogynecology clinic for LUTS completed two questionnaires, (i) International Consultation on Incontinence Modular Questionnaire for Overactive Bladder (ICIQ-OAB), and (ii) Generalized Anxiety Disorder 7-Item Scale (GAD-7). Based on ICIQ-OAB scores greater than or equal to 28, patients were dichotomized as having OAB versus LUTS-other (typically patients referred for stress urinary incontinence). GAD-7 scores categorized patients as having anxiety using a cut-off of greater than or equal to 14. A 2x2 contingency table was created, and a 2-tailed Fisher’s exact test was used to test the association between OAB and anxiety. Demographic variables included age, parity, menopausal status, hormone replacement, smoking, recreational drug use, alcohol consumption, caffeine intake, total daily fluid intake, post-void residual urine volume (PVR), depression, use of beta-blockers and anxiolytics, marital/partner status, post-secondary education (as a surrogate for socioeconomic status), and pre-existing anxiety diagnosis. Significant confounders were included in a logistic regression analysis. We hypothesized that 25% of OAB patients would be categorized as having anxiety, versus 5% of LUTS-other patients, and sample size calculation indicated a need for 100 subjects. To account for incomplete questionnaires, we recruited 105 subjects. Institutional research ethics approval was obtained.

Results: One hundred five subjects were enrolled, 1 subject was excluded due to incomplete questionnaires, leaving 104 subjects. Sixty-five patients had OAB and 39 had LUTS-other. Of the OAB patients, 17/65 (26.2%) were categorized as having anxiety, compared to 3/39 (7.7%) of the LUTS-other group (p=0.038 by Fisher’s exact test). Of the potential cofounders, only post-secondary education significantly differed between OAB patients (51/65=78.5%) and LUTS-other patients (37/39=94.9%) (p=0.03 by Fisher’s exact test). When including post-secondary education into the regression analysis, the significance level for the association between OAB and anxiety dropped to p=0.056.

Conclusions: There appears to be a significant association between OAB and anxiety, and it may be of clinical importance to assess for anxiety in patients who present with OAB symptoms. The drop in statistical significance from p=0.038 to a borderline significance of p=0.056 in the regression analysis may be a reflection of the sample size, and a larger study will be required to assess this.

Disclosure:

Work supported by industry: no.

002

What happens to urinary incontinence after pelvic organ prolapse surgery?

Ugianskiene, A 1 ; Kjærgaard, N 1 ; Larsen, T 1 ; Glavind, K 1

1: Aalborg University Hospital

Introduction: Pelvic organ prolapse (POP) and urinary incontinence (UI) commonly coexist. The beneficial effect of POP surgery on urge UI is well described in the literature, while effect on preoperative stress UI is still unclear. Some physicians combine the anti-incontinence surgery with POP repair, while others choose a two-step strategy (correction of the prolapse first and re-evaluation of UI afterwards). The argument for the two-step procedure is that anti-incontinence surgery could be an unnecessary surgical intervention in almost one-third of patients who might be cured by prolapse surgery alone.

Objective: The purpose of this study was to investigate changes concerning UI following POP surgery without concomitant anti-incontinence procedures and to identify possible factors influencing the changes.

Methods: Retrospective study of 678 women with prolapse surgery using native tissue repair during a 3-year period. Patients completed three prolapse questions from the International Consultation on Incontinence-Vaginal Symptoms (ICIQ-VS) and the International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF) before undergoing surgery and 3 months postoperatively. Patients with urinary incontinence defined as a score of more than zero on ICIQ-UI SF preoperatively were included in this study. We compared two groups of patients: patients with no UI at 3 months follow-up and patients who remained incontinent after POP surgery. We investigated demographic data (table 1) and differences in operations in the three compartments.

Results: A total of 379 patients (55.9 %) with POP had concomitant UI. At 3 months follow-up, 174 patients (46%) became continent leaving 205 patients (54%) with urinary incontinence. A total of 35% of patients, who remained incontinent after POP surgery according to ICIQ-UI SF had an improvement in UI, 6.9% had unchanged UI and 12.1% deterioration of UI symptoms. A total of 53% of women with preoperative SUI were subjectively cured by POP surgery alone (Figure 1). The risk of remaining UI after POP surgery was increased in patients with previous anti-incontinence repair compared to patients without (p=0.045). Patients with remaining UI at 3 months follow-up had a statistically significant higher mean preoperative ICIQ-UI SF score compared to patients who became dry.

Conclusions: Almost half of the patients with UI before POP surgery became completely dry after prolapse surgery alone. Over 50% of women with preoperatively SUI were cured with POP surgery alone and therefore the “two-step procedure” in management of vaginal prolapse and SUI is recommended. Previous anti-incontinence surgery was identified as a risk factor for remaining UI after POP surgery. Patients with more severe incontinence were less likely to become continent after a prolapse operation. We found reduction in incontinence after an operation in any of the three compartments.

  No UI after surgery
N=174
Postoperatively UI
N=205
P value
Age, median (range) 55 (22-76) 55 (20-80) 0,78a
Parity, median (range), years 2 (0-6) 2 (0-5) 0,92a
Body mass index, kg/m²: mean (range) 26,4 (19,10-37,70) 27 (18,6-40,9) 0,16a
Cesarean section: n (%) 11 (6,3%) 12 (5,9%) NSb
Previous hysterectomy: n (%) 36 (20,7%) 45 (22%) NSb
Previous prolapse surgery: n (%) 41 (23,6%) 66 (32,2%) NSb
Previous anti-incontinence repair: n (%) 1 (0,6%) 8 (3,9%) 0,045c

Table 1.

Demographics of the patients with no incontinence and remaining incontinence at 3 months follow-up.

UI –urinary incontinence.

a Mann-Whitney test

b Chi-square test

c Fishers exact test

figurea

Figure 1.

Presence of urinary incontinence before and after surgery

UI – urinary incontinence.

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Work supported by industry: no.

003

Urinary incontinence and incident frailty in older women: sub-analysis of the women's health initiative observational study

Chen, CCG1; Avondstondt, AM1; Tian, J2; Wallace, RB3; Walston, JD4; Bandeen-Roche , K4

1: Johns Hopkins School of Medicine, Department of Gynecology and Obstetrics; 2: Johns Hopkins Bloomberg School of Public Health Center on Aging and Health ; 3: University of Iowa College of Public Health; 4: Johns Hopkins Bloomberg School of Public Health Center on Aging and Health

Introduction: Frailty refers to decreased physiological reserve and is a biologic syndrome of persons 65 years and older, distinct from associated co-morbidities and disability. Frailty is prevalent in older patients seeking treatment for pelvic floor disorders, however, the association between urinary incontinence (UI) and frailty is not well established.

Objectives: To compare baseline and year 3 data from the Women’s Health Initiative-Observational Study (WHI-OS) to determine if existing UI is associated with existing and incident frailty.

Methods: This prospective, observational study recruited women aged 50–79 years from 40 clinical centers across the United States. Eligibility criteria included postmenopausal status, not enrolled other clinical trials, did not have issues that may interfere with compliance, and were not likely to move or survive less than 3 years. Demographics, medical and psychosocial comorbidities, health behaviors at baseline and at year 3, anthropomorphic measurements such as body mass index were collected. Our complete case baseline frailty analysis and incident frailty analysis was based on 35,753 and 17,721 women, respectively, aged 65–79 years without Parkinson’s disease and not missing frailty phenotype parameters, urinary incontinence variable, or other relevant covariates.

Results: At baseline, 74.2% of participants reported UI and 27.5% and 19.5% of participants were categorized as pre-frail and frail, respectively. UI was independently associated with baseline pre-frailty and frailty (OR 1.14, 95% CI 1.07 – 1.22; OR 1.54, 95% CI 1.41 – 1.68; respectively) after adjusting for previously published independent predictors of frailty. Baseline UI was independently associated with incident pre-frailty and frailty (OR 1.24, 95% CI 1.14 – 1.35; OR 1.42, 95% CI 1.22 – 1.65; respectively). As UI severity, impact, and amount of bother increased, the stronger the association noted with incident pre-frailty and frailty.

Conclusion: Baseline UI was shown to predict incident frailty. Recognition of this frailty risk factor and potential for early intervention could have profound implications in improving older patients’ quality of life and function.

Odds Ratio (OR) relating baseline urinary incontinence to incident frailty at year 3 (n=20731) #

  Pre-Frailty Frailty
Urinary Incontinence (UI) Characteristics Unadjusted OR (95% CI) p-value Adjusted OR* (95% CI) p-value (MI) Unadjusted OR
(95% CI) p-value
Adjusted OR*
(95% CI) p-value (MI)
Amount of urine loss     
Barely noticeable 1.13 (1.05-1.22)
0.0013
1.10 (1.01-1.19)
0.024
1.29 (1.14-1.45)
<0.0001
1.21 (1.07-1.38)
0.0028
Soak underpants 1.58 (1.41-1.78)
<0.0001
1.39 (1.23-1.58)
<0.0001
1.92 (1.61-2.29)
<0.0001
1.64 (1.34-1.99)
<0.0001
Soak outer clothing 1.29 (0.95-1.77)
0.11
1.11 (0.80-1.54)
0.52
2.60 (1.78-3.80)
<0.0001
1.99 (1.33-2.98)
<0.0001
Impact of UI     
Never/almost never 1.20 (1.11-1.29)
<0.0001
1.15 (1.05-1.24)
0.0012
1.36 (1.20-1.54)
0.0002
1.28 (1.12-1.46)
0.0003
Sometimes 1.47 (1.15-1.87)
0.0020
1.18 (0.91-1.54)
0.20
2.61 (1.92-3.55)
<0.0001
1.99 (1.43-2.76)
<0.0001
Fairly often/very often 2.04 (1.27-3.28)
0.0033
1.65 (1.02-2.69)
0.043
4.77 (2.80-8.11)
<0.0001
3.30 (1.84-5.89)
<0.0001
Amount bothered by UI     
Not at all/a little 1.13 (1.05-1.23)
0.0019
1.11 (1.01-1.20)
0.021
1.22 (1.07-1.39)
0.0024
1.17 (1.02-1.35)
0.024
Somewhat 1.44 (1.28-1.61)
<0.0001
1.30 (1.14-1.47)
<0.0001
1.92 (1.62-2.28)
<0.0001
1.72 (1.42-2.07)
<0.0001
Very/extremely 1.56 (1.34-1.81)
<0.0001
1.33 (1.14-1.56)
0.0003
2.31 (1.88-2.85)
<0.0001
1.91 (1.52-2.40)
<0.0001

Multinomial logistic regression with multiple imputation (MI) of missing data using no incontinence as reference group.

# Participants not pre-frail (n=10836, 27.6%) or frail (n=7681, 19.6%) at baseline.

*Adjusted by age, race, education, income, live alone, tobacco and alcohol use, BMI, self-reported general health, hormone use, number of co-morbidities (diabetes, hypertension, arthritis, cancer, liver disease, heart disease, hip fracture, and stroke), and any disability in performing activities of daily living.

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Work supported by industry: no.

004

What women want - their interpretation of the concept of cure

Flint, R 1 ; Thiagamoorthy, G 2 ; Rajshekhar, S 2 ; Robinson , D 2 ; Cardozo, L 2

1: King's College Hospital; 2: King's College Hospital

Introduction: Cure is defined as ‘restoration to health or good condition’1. Subjective cure is dependent upon the reporting of clinical symptoms alone, objective cure is based on a measurable outcome, the latter is regarded as more robust.

Objective: The primary aim of this study was to determine what women with lower urinary tract symptoms (LUTS) perceive as ‘cure’ and to assess acceptability of treatment. The secondary aim was to discover any relationship between symptom severity and expectations.

Methods: Women were recruited prospectively from a tertiary urogynaecology-unit. All complained of LUTS. Assessment of symptoms was performed using the King’s Health Questionnaire (KHQ)2, subjective assessment of ‘cure’ was performed using a specially designed questionnaire. Results were collected and analysed using SPSS. Correlation was performed using Kendall’s tau b3.

Results: 127 women were recruited. Table 1 shows women’s expectations of cure. 54% of women wanted a good improvement in their symptoms so they no longer interfered with their lives. Table 2 shows acceptability of symptoms. 80% were happy to perform pelvic floor exercises, followed by 57% accepting drugs as and when required and 53% performing pelvic floor exercises for the remainder of their lives.

TABLE 1: EXPECTATIONS OF TREATMENT n=127

Complete cure of all bladder symptoms 15%
A good improvement so they no longer interfere with your life 54%
Being able to cope better so your life is affected less 13%
Any improvement in your bladder symptoms, no matter how small 19%

TABLE 2: ACCEPTABILITY OF SYMPTOMS

n=127 Yes % Maybe % No %
Never ever leaking no matter what you do 64 14 22
Occasional small leak on coughing or sneezing 36 39 24
Occasional small leak with strenuous exercise 24 38 38
Occasional large leak on coughing or sneezing 17 17 66
Frequent small leaks on coughing or sneezing 20 17 63
A sudden urge or need to pass water (no leaking) 44 24 32
Occasionally leaking before you reach the toilet 19 24 57
Having to pass water very often during the day 24 36 39
Having to get up once at night to pass water 41 42 17
Having to get up twice or more at night to pass water 24 17 59
Occasionally having to wear panty liners ‘just in case’ 42 28 30
Occasionally having to wear pads ‘just in case’ 31 18 50
Having to continue to wear pads most of the time 20 13 67
Leaking during sexual intercourse 20 10 70

The most important symptom to cure was incontinence 53%, followed by frequency 7% and urgency 7%. The most common urodynamic finding was normal urodynamics 40% followed by detrusor overactivity 22% and urodynamic stress incontinence 18%. We demonstrated a positive correlation between those whose disease had a lesser impact on their quality of life (QOL) (lower KHQ scores), and the preference to avoid more invasive treatment (0.171, p=0.008). Whilst with increasing impact on QOL, there is acceptance for more invasive therapy. There was no correlation between QOL and expectations of treatment or acceptability of symptoms. 35% of women would accept mesh to improve their LUTS.

Conclusion: These findings suggest the majority of women with LUTS have realistic expectations regarding outcome and are able to tolerate minor LUTS. Patients whose LUTS have a lower impact on their QOL are more likely to prefer less invasive treatment. As such a larger emphasis should be placed on conservative management and the provision of appropriate services such as specialist nurses and specialist women’s health physiotherapists.

References:1. Oxford English Dictionary, Oxford Press, London. UK. 2. A new questionnaire to assess the quality of life of urinary incontinent women. 1997. Br J Obstet Gynaecol; 104: 1374-1379. 3. Practical Statistics for Medical Research. Chapman and Hall, London. UK.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Allergan, Pfizer, Ferring, Astellas).

005

Pelvic floor muscle activity patterns in women with and without stress urinary incontinence during running: a wavelet approach

Koenig, I 1 ; Eichelberger, P 2 ; Leitner, M 2 ; Moser, H 2 ; Kuhn, A 3 ; Taeymans, J 1 ; Radlinger, L 2

1: 1 Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Bern, Switzerland; 2 Vrije Universiteit Brussel, Faculty of Physical Education and Physiotherapy, Brussel, Belgium; 2: 1 Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Bern, Switzerland; 3: 3 Women’s Hospital, Urogynaecology, Bern University Hospital and University of Bern, Bern, Switzerland

Introduction: Running is known to cause urinary leakage in women with stress urinary incontinence (SUI)1. Small and large alpha-motoneurons of pelvic floor muscles (PFM) are recruited to match their contractile muscle properties to the impact of initial contact while running. The frequency content of electromyographic (EMG) signals enables estimating the activated types of alpha-motoneurons. Small alpha-motoneurons are responsible for the lower frequencies in the signal and large alpha-motoneurons for higher frequencies related to the recruitment of slow and fast muscle fiber types. Wavelet analyses of EMG signals allow the identification of activation intensity and frequency content in the range of a few milliseconds with high time resolution2. The evaluation of motor unit recruitment behavior of PFM at initial contact and in the pre- and post-initial contact phase sheds light on specific differences of involuntary reflexive activation patterns.

Objective: The purpose of this study was to evaluate the PFM EMG median frequencies using wavelet analysis at three different running speeds and to compare median frequencies (MF) of continent women and women with SUI.

Methods: An EMG data analysis was performed on twenty-eight continent (CON) and twenty-one women with SUI. PFM EMG was recorded during 10 s at 7, 11 and 15 km/h treadmill running. EMG data were normalized to peak activity during maximum voluntary contraction. PFM EMG was analyzed with a continuous wavelet transform using Morse wavelets. To assess involuntary PFM activity, power spectra were extracted within six time intervals of 30 ms from -30 ms before to 150 ms after initial contact3.

Results: The mean MF of each time interval showed no group differences. The mean MF varied between 73.9 and 88.2 Hz (SD: 12.2-18.3 Hz) in group CON and between 66.5 and 85.1 Hz (SD: 13.1-21.9 Hz) in group SUI. In the time interval 120-150 ms after initial contact, both groups showed significantly lower mean MFs during running at 15 km/h than during running at 7 km/h. The highest mean MFs were found in the pre-initial contact interval in both groups and in all speeds. In both groups mean MFs were significantly higher in the pre-activation phase than in the post-initial contact time intervals.

Conclusion: Although the groups did not differ significantly, differences in the motor unit recruitment behavior in the pre- and post-initial contact phase could be identified. The neuro-muscular control system reacts at each initial contact with muscular preparation and adaptation. Wavelet analyses made it possible to analyze this muscular anticipation a few milliseconds before initial contact. The higher mean MFs in the pre-initial contact phase identified a feed-forward adaption of PFM to the impact of the initial contact event. This was demonstrated by a higher content of recruited large alpha-motoneurons and a presumably faster PFM contraction in order to contribute to continence.

References:

1 Abrams et al. (2003), Urology

2 von Tscharner (2000), J Electromygr Kinesiol

3 Fleischmann et al. (2011), J Appl Physiol

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Work supported by industry: no.

006

Do lower urinary tract and pelvic floor symptoms correlate with uterine fibroid size and location?

Shaffer, RK1; Dobberfuhl, AD2; Vu, KN3; Fast, A3; Hovsepian, D3; Lum, D1; Ghanouni, P3; Chen, B1

1: Department of OB/GYN, Stanford University School of Medicine; 2: Department of Urology, Stanford University School of Medicine; 3: Department of Radiology, Stanford University School of Medicine

Introduction: Uterine fibroids are prevalent and often co-exist with lower urinary tract symptoms (LUTS) and pelvic floor symptoms. The association of fibroid size, location, and uterine enlargement with LUTS and pelvic floor symptom severity is largely unproven and based on limited data using ultrasound measurements.

Objective: To examine the correlation between pelvic floor symptoms/LUTS, relevant clinical and demographic history, and uterine fibroids using magnetic resonance imaging (MRI). Correlations between LUTS and specific fibroid or pelvic characteristics may impact treatment counseling.

Methods: A retrospective review (2013-2017) of a multidisciplinary fibroid clinic patient population identified 369 women with a complete Pelvic Floor Distress Inventory survey (PFDI; score 0-300, worse symptoms with higher scores) and pelvic MRI. Multiple linear regression was used to assess the influence of clinical factors and MRI findings on total PFDI scores and urogenital distress inventory subscore (UDI6; score 0-100), which assesses LUTS including urinary frequency, urgency, incontinence, and urogenital discomfort. Data were analyzed in STATA.

Results: Patients had a mean age of 43.9 years (SD 6.9), a median PFDI score of 72.7 (IQR 71.9), and a median UDI6 subscore of 29.1 (IQR 29.9) with a right-skewed, non-normal distribution. Overall, 79.1% of women reported urinary frequency, 75.3% experienced genital discomfort, and 55.3% had urge incontinence. Fibroid location (relative to bony landmarks) revealed two-thirds of patients had fibroids extending into the abdomen, while one-third had fibroids confined to the true pelvis (p=0.016). Spearman’s correlation showed that depth of the sacroccygeal curve was significantly associated with PFDI (r=0.116, p=0.027) while uterine volume (p=0.19) and dominant fibroid volume (p=0.21) were not associated with PFDI. Kruskal-wallis rank test found no significant association between fibroid location on the uterus (anterior, posterior, fundal) or within the uterine wall (intramural, submucosal, subserosal, pedunculated) and total PFDI subscore or UDI6 subscore. Multivariate linear regression showed that increased PFDI score was significantly associated with increased BMI (β=1.47 points per 1-point BMI, 95% CI 0.5-2.4; p=0.003), increased parity (β=7.43, 95% CI 2.3-12.5; p=0.004), presence of past or current smoking (β=26.2, 95% CI 7.9-44.5; p=0.005), presence of concomitant diabetes (β=26.1, 95%CI 1.5-50.7; p=0.038), and history of surgery for incontinence (β=50.5, 95%CI 7.6-93.5; p=0.021). Asian race was significantly associated with lower PFDI score (β=-15.5, 95%CI -30.0- -0.9; p=0.036) and African American race trended with higher PFDI scores (β=16.3, 95%CI -0.99-33.5; p=0.065). UDI6 subscore was significantly associated with these factors as well as diuretic use (β=13.1, 95%CI 1.5-24.7; p=0.027). After multivariate adjustment, sacrococcygeal curve depth and fibroid location within the true pelvis vs abdomen were not significantly associated with PFDI or UDI6 scores.

Conclusion: Contrary to common belief, LUTS and pelvic floor symptoms were not significantly associated with uterine volume or fibroid size or location, whereas clinical predictors of BMI, medical history, and medication use not related to uterine fibroids were significant predictors of LUTS and pelvic floor symptoms. Careful attention to these factors is recommended when evaluating LUTS and pelvic floor symptoms thought to be due to uterine fibroids.

Current word count: 488

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007

Transobturator versus transvaginal sling for reducing overactive bladder symptoms in women undergoing surgery for mixed urinary incontinence: a prospective randomized study

Garate, MJ 1 ; Rondini, C 2 ; Urzua, MJ 3 ; Monroy, M 1 ; Andreoli, F 1 ; Alvarez, J 2

1: Hospital Padre Hurtado; 2: Hospital Padre Hurtado and Clinica Santa Maria; 3: Hospital Padre Hurtado and Clinica Davila

Introduction: Mid-urethral slings (MUS) have become the gold standard of care for the treatment of female stress urinary incontinence. Recent retrospective studies have shown some improvement in overactive bladder (OAB) symptoms when women undergo MUS procedures. However, to date, there are no prospective randomized studies comparing the retropubic versus the transobturator approach an OAB point of view.

Objective: The aim of this study is to evaluate the improvement of OAB symptoms in patients undergoing MUS surgery for mixed urinary incontinence and compare the retropubic (RP) approach versus transobturator (TO).

Methods: Female patients evaluated at a tertiary referral center with mixed urinary incontinence were invited to participate. In order to demonstrate a significant decrease in urge-incontinence episodes between both procedures, a sample-size of 198 patients were needed. Exclusion criteria included previous incontinence surgery and failure to consent. Urgency, frequency, and urge-incontinence episodes were obtained from bladder diaries. Patients´ OAB symptoms were evaluated using validated questionnaires (UDI-6, KHQ y OAB-q). To analyze overall patient satisfaction Patient Global Improvement-Index (PGI-I). Patients were evaluated by a senior member of the urogynecology department prior to surgery, at 6 and 12 months follow-up. During the follow-up visist, patients were asked to complete questionnaires and bring updated bladder diaries. For the statistical analysis, Chi-square was used for categorical variables and Mann Whitney or Wilcoxon for continuous non-parametric variables.

Results: Two hundred and four women agreed to participate. Of these, 47.5% were randomized to TO and 52.5% to RP. Demographic variables and questionnaire scores were similar in both groups (Table no.1). When analyzing post-operative questionnaire there was a clear overall improvement with respect to the pre-operative scores in both techniques. However, there was a significant difference in favor of the transobturator approach when comparing the reduction in the number of post-operative urge-incontinence episodes (RP: 2.6 vs., TO 3.7, p: 0.047). Even though there was a higher reduction in urge incontinence episodes in the TO group, a higher percentage of women in the retropubic group were found more likely to recommend the surgery for their OABs (RP: 97.4% vs., TO 85.5%, p: 0.010). Over all Patient perception of improvement as expressed by PGI-I “equal” or “worst” was also in favor of the RP approach (RP 2.6% vs., TO 13.0% p: 0.018). There was no significant difference in the validated questionnaires following surgery. Post-operative complications were also similar in both groups (RP 17.1% vs TO 11.6%, p: 0.346). Only two patients had urinary retention requiring sling loosening or division, both in the RP.

Conclusion: The transobturator approach significantly reduced the number of urge-incontinence episodes, however it is unclear how much a difference of one episode a day of urge incontinence can impact the quality of life of women as shown on the PGI-I and questionnaires.

Table #1: Demographic characteristics and Questionnaire scores prior to surgery

  TOT TVT * p Value
Age (years) 53.4 ± 9.96 52.7 ± 11.6 0.680
Parity 3.56 ± 1.9 2.96 ± 1.58 0.499
BMI 31.96 ± 5.1 30.89 ± 4.4 0.220
UDI-6 15.7 ± 7.5 15.99 ± 6.6 0.757
KHQ 537.1 ± 264.6 538 ± 235.4 0.595
OAB-q 1-8 19.8 ± 9.5 19.88 ± 8.4 0.656
OAB-q 9-33 63.4 ± 35.9 60.55 ± 33.5 0.502

Tabla#2. The difference in means between pre and post- operative questionnaires

  TOT TVT * p Value
UDI-6 9.6 ± 7.8 9.7 ± 7.7 0.912
KHQ 37.2 ± 28.3 37.4 ± 27.4 0.962
OAB-q 1-8 11.3 ± 10.6 11.4 ± 9.5 0.962
OAB-q 9-33 43.1 ± 39.0 41.1 ± 38.9 0.713
PGI-I 87.0 % 97.4% 0.018

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008

Surgery for complications following mid-urethral mesh tape insertion among women with stress urinary incontinence: A national population-based cohort study in England

Tincello, D 1 ; Gurol-Urganci, I 2 ; Geary, R 2 ; Mamza, J 2 ; Duckett, J 3 ; El-Hamamsy, D 1 ; Dolan, L 4 ; van der Meulen, J 2

1: University of Leicester; 2: London School of Hygiene and Tropical Medicine; 3: Medway Maritime Hospital; 4: Belfast City Hospital

Introduction: There is growing concern worldwide about outcomes of mid-urethral mesh tape (MUT) insertion for women with stress urinary incontinence (SUI), and in particular the incidence of mesh complications of pain, and the need for further surgery for pain. Several patient groups, supported by political opinion are campaigning for mesh surgery to be banned, although accurate data on complications and the need for later surgery is lacking.

Objective: To identify the true incidence of surgical removals and re-operations after MUT insertion by analysis of the Hospital Episodes Statistics for England database over a 10 year period.

Method: Women aged 18 or older who had a first-ever MUT insertion for SUI between April 2006 and December 2015 were identified and followed up until April 2016 in administrative data of all admissions in English National Health Service hospitals. Primary outcome was MUT removal and secondary outcome was any SUI reoperation (including removals). Kaplan-Meier methods were used to estimate removal and reoperation risks and proportional hazards regression to estimate adjusted hazard ratios (aHR) representing the impact of patient and hospital factors.

Results: 95,058 women were included. Rate of MUT removal was 1.4% (95%CI 1.3%-1.5%) at 1 year, 2.8% (2.7%-2.9%) at 5 years and 3.4% (3.2%-3.5%) at 9 years. Risk of removal declined with age and was lower for Asian/Asian-British women compared to white women (aHR 0.68, 0.50-0.91). Transobturator MUT insertion was associated with lower risk of mesh removal than retropubic insertion (aHR 0.74, 0.67-0.82). Reoperation rate was 2.7% (2.6%-2.8%) at 1 year, 5.7% (5.6%-5.9%) at 5 years and 7.1% (6.9%-7.3%) at 9 years.

Table. Selected Risks and Hazard ratio

   Risk of removal* (%)   
Number (%) 1-year (95% CI) 5-year (95% CI) aHR (95% CI) ^ P-value
Total 95058 (100) 1.4 (1.3, 1.5) 2.8 (2.7, 2.9)   
Age at initial surgery (yrs)
18-39 10292 (10.8) 2.0 (1.7, 2.3) 3.6 (3.2, 4.0) Reference <0.001
40-49 33095 (34.8) 1.5 (1.4, 1.6) 3.0 (2.8, 3.2) 0.83 (0.74, 0.94)  
50-59 24664 (26.0) 1.4 (1.2, 1.5) 2.9 (2.7, 3.1) 0.79 (0.69, 0.89)  
60-69 16877 (17.8) 1.1 (0.9, 1.2) 2.2 (2.0, 2.5) 0.61 (0.53, 0.71)  
70+ 10130 (10.7) 1.1 (0.9, 1.3) 2.0 (1.7, 2.3) 0.55 (0.47, 0.66)  
Ethnic background
White 91057 (95.8) 1.4 (1.3, 1.5) 2.8 (2.7, 2.9) Reference 0.01
Asian/Asian-British 2234 (2.4) 0.9 (0.6, 1.4) 2.1 (1.6, 2.9) 0.68 (0.50, 0.91)  
Black/black-British 611 (0.6) 1.7 (0.9, 3.1) 2.3 (1.3, 3.9) 0.70 (0.40, 1.21)  
Other 1149 (1.2) 0.9 (0.5, 1.6) 2.0 (1.3, 3.0) 0.68 (0.45, 1.02)  
Route of tape insertion
Retropubic 60194 (63.3) 1.7 (1.6, 1.8) 3.1 (2.9, 3.2) Reference <0.001
Transobturator 34864 (36.7) 0.9 (0.8, 1.0) 2.2 (2.1, 2.4) 0.74 (0.67, 0.82)  

Conclusion: The MUT removal rate was 1 in 30 and the reoperation rate was 1 in 14 women within 9 years of initial insertion. The removal risks were higher with retropubic than transobturator insertion. These data provide robust evidence to aid clinical decision-making, advise patients, and inform clinical guidelines.

Disclosure:

Work supported by industry: no, by Douglas Tincello. A consultant, employee (part time or full time) or shareholder is among the authors (Cambridge Medical Robotics, Allergan).

009

Birthweight and pelvic floor trauma

Martinho, N 1 ; Talia, F 2 ; Turel, F 2 ; Robledo, K 2 ; Dietz, HP 2

1: Faculty of Medical Sciences, State University of Campinas - UNICAMP, Brazil.; 2: Sydney Medical School Nepean, University of Sydney, Australia

Introduction: Vaginal childbirth is the primary environmental factor in the etiology of pelvic organ prolapse (POP), at least partly mediated by trauma to the levator ani muscle (LAM)1. There is evidence that most obstetric trauma occurs due to the first vaginal delivery2 and birthweight seems to be a risk factor for LAM avulsion and POP3.

Objective: To investigate whether the birthweight of the first vaginally born baby is more important for the development of avulsion and/or POP than the birthweight of subsequent vaginally born babies.

Methods: Archived data sets of patients seen at two tertiary urogynaecological centers from July 2014 to July 2017 were evaluated. Patients underwent a physician-directed interview for personal and obstetric data, followed by clinical examination (Pelvic Organ Prolapse Quantification - POPQ) and 4D transperineal ultrasound (TPUS). Ultrasound volume data sets were obtained at rest, on pelvic floor muscle contraction and maximal Valsalva. Using 4D View software, the investigator, blinded to all other data, performed offline analysis of LAM integrity, pelvic organs descent and hiatal area on Valsalva. We then tested any association between birthweight and avulsion and symptoms/signs of prolapse, and quantified the contribution of birthweight to avulsion using predictive models.

Results: During the inclusion period, 1575 patients were seen. We were unable to retrieve ultrasound volumes in 23 and excluded women with less than one vaginal birth (n=373) and cases without birthweight data (n=54), leaving 1125. Mean age was 57.1±12.5 years (24.2-89.7), mean BMI 29.5±6.3 kg/m2 (15.7-58.8). 693 women were found to have a significant cystocele, 646 a significant rectocele (both defined as POPQ >=stage II), 220 had significant uterine prolapse (POPQ stage >=1). On TPUS, 293 women had a full unilateral or bilateral avulsion. Significant associations were found between birthweight and avulsion as well as significant prolapse on POPQ (Table 1).

The best univariate predictor for levator ani muscle avulsion was the birthweight of the first vaginally born baby (AUC=0.574) when compared to the maximum weight of any vaginally born baby (AUC=0.540). Even when adjusted for maternal age and forceps, the AUC for the birthweight of the first vaginally born baby was 0.634 and for the maximum weight of any vaginally born baby was 0.628.

Table 1. Association between birthweight and LAM trauma as well as signs/symptoms of prolapse (t-tests).

   Birthweight of the first vaginally born baby (g) Maximum weight of any vaginally born baby (g)
Symptoms of prolapse (M±SD) 1 YES (n=619) 3377 (± 0.563) vs 3343 (± 0.578) p=0.33 3693 (± 0.557) vs 3696 (± 0.562) p=0.91
NO (n=506)
Significant prolapse on POPQ (M±SD) 1 YES (n=919) 3377 (± 0.568) vs 3292 (± 0.573) p=0.05 3711 (± 0.571) vs 3618 (± 0.495) p=0.03
NO (n=205)
Significant prolapse on US(M±SD) 1 YES (n=787) 3375 (± 0.569) vs 3331 (± 0.571) p=0.24 3708 (± 0.566) vs 3663 (± 0.541) p=0.22
NO (n=338)
Levator ani muscle avulsion 1 YES (n=293) 3467 (± 0.553) vs 3324 (± 0.571) p<0.001 3755 (± 0.536) vs 3673 (± 0.565) p=0.03
NO (n=832)

Conclusion: A large first baby is associated with an increased risk for LAM avulsion and seems to be a more powerful predictor compared to maximal birthweight.

References:

1. Br J Obstet Gynaecol 2008;115(8):979-984;

2. Ultrasound Obstet Gynecol 2017;50(1):110-115;

3. Female Pelvic Med Reconstr Surg 2016;22(5):292-296.

Disclosure:

Work supported by industry: no.

010

A correlation between the second stage of labor and pelvic floor dysfunction symptoms during pregnancy and postpartum recovery

Weintraub, AW 1 ; Pardo, E 1 ; Rotem, R 1 ; Glinter, H 1 ; Erenberg, M 1 ; Yahav, L 1 ; Yohay, Z 1 ; Yohay, D 1

1: Department of Obstetrics and Gynecology, Faculty of Health Sciences, Ben-Gurion University of the Negev, Soroka University Medical Center

Introduction: Pelvic floor dysfunction (PFD) symptoms are prevalent during pregnancy and mostly reversible thereafter. During the second stage of labor (SSL), apart from uterine contractions, expulsion of the fetus may be linked to the added forces of the pelvic floor muscles and the resistance of the pelvic floor soft tissue (muscles, ligaments and connective tissue). We hypothesized that the duration of the SSL is correlated with the presence of PFD symptoms during pregnancy as well as with the recovery of PFD symptoms during the postpartum. Studies investigating PFD during pregnancy and the postpartum are scarce and further studies are needed in order to better understand its impact on parturient long-term outcomes, wellbeing and quality of life.

Objectives: The purpose of this study was to evaluate whether there is a correlation between PFD symptoms during pregnancy and their postpartum recovery with the duration of the SSL.

Study Design: We conducted a prospective longitudinal study of women who gave birth. Those who consented completed the Pelvic Floor Distress Inventory-20 (PFDI-20), after delivery and three months postpartum. This is a condition specific questionnaire developed and validated to measure quality-of-life and the extent of injury to the pelvic floor. The difference between the two scores was calculated to represent recovery of PFD symptoms. The duration of the SSL and clinical and obstetrical characteristics were retrieved from the participants' medical records.

Results: Of the 200 women who completed the questionnaire, 151 underwent vaginal delivery (75.5%). PFD during pregnancy was found to be correlated to the duration of the SSL (R= -0.183, P=0.021). When evaluating each component of the PFDI-20 separately, colorectal and anal distress was significantly associated with the duration of the SSL (R=-0.195, P=0.01). Specifically, the symptom of pain during defecation (R=-0.264, P=0.01) was correlated with a shorter duration of the SSL. Three months postpartum, 117 women had completed the PFDI-20. We found a significant difference between PFD during pregnancy and three months postpartum (P<0.001). This significant difference remained consistent in all components of the PFDI-20: pelvic organ prolapse distress (P<0.001), colorectal and anal dysfunction (P<0.001) and urinary dysfunction (P<0.001). In addition, a more profound recovery of colorectal and anal dysfunction symptoms was significantly associated with a shorter duration of the SSL (P=0.03).

Conclusions: A correlation exists between PFD during pregnancy and the SSL. Specifically, symptoms of colorectal and anal distress in late pregnancy are correlated to a shorter duration of the SSL. There is a profound clinical and statistically significant spontaneous recovery of PFD symptoms in the postpartum period. Finally, a shorter duration of the SSL is significantly associated with a greater recovery of colorectal and anal dysfunction symptoms.

figureb
figurec

Disclosure:

Work supported by industry: no, by Ella Pardo -.

011

Structural changes in the puborectalis muscle after vaginal delivery

Verheijen - van de Waarsenburg, K 1 ; van der Vaart, H 1 ; Withagen, M 1

1: UMC Utrecht

Introduction: The extent of trauma and differences on trauma healing after vaginal delivery, may be associated with the development of pelvic floor disorders in later life. An important part of the functional recovery of the puborectalis muscle occurs within the first three weeks after vaginal delivery. However, stretch of the puborectalis muscle, reflected by distensibility of the hiatal area during Valsalva, remained consistently increased up until 24 weeks. Echogenicity measurements can be used to assess the structure of muscle tissue. Knowledge about the structural composition of the puborectalis muscle during recovery after delivery may help us understanding functional recovery.

Objective: This study is designed to evaluate the structural composition of the puborectalis muscle at several moments after first vaginal delivery, by the use of echogenicity and area measurements.

Methods: This study is part of a prospective multicenter cohort study on the association between the mean echogenicity of the puborectalis muscle (MEP) and mode of delivery. The first 20 consecutive patients who delivered vaginally and gave informed consent for an extensive follow up were selected. 3D/4D transperineal ultrasound assessments were performed at 12 weeks’ gestation and at 1 day and 1, 2, 3, 4, 6, 12, 18 and 24 weeks after vaginal delivery. The images were made at our clinic or at the home of the women, according to her preference. The ultrasound devices used were either the GE Voluson 730 Expert system or the portable Voluson i. During the examination perineal volume images were made at rest, contraction and on Valsalva maneuver. Offline analysis was performed using 4D View 7.0 and Matlab® R2010a software. The plane of minimal hiatal dimension of the levator hiatus in axial position was selected in 4D View and transported to Matlab to delineate the puborectalis muscle for measurements of the MEP and area of the puborectalis muscle (PMA). Statistical analysis was performed using SPSS version 22.0 for Windows. MEP and PMA were described as medians with ranges. The Wilcoxon Signed Rank Test was used to compare the different data. P<0.05 was considered statistical significant.

Results: After delivery the MEP is statistical significantly decreased compared to the MEP during pregnancy at all time intervals. After delivery, the MEP values increased significantly over time from day 1 to 24 weeks after delivery. The PMA remained constant after delivery at rest and during Valsalva maneuver. Although not statistical significant we observed a remarkable drop in MEP between 3 and 4 weeks in all maneuvers.

figured
figuree

Conclusions: As compared to pregnancy levels we observed a sharp decrease in echogenicity soon after delivery, which is most likely caused by stretch trauma of the puborectalis muscle and subsequent (micro) hematoma formation. Afterwards the increasing MEP may reflect the disappearance of hematoma and edema and also the formation of connective tissue. It is known that muscles after stretch trauma show a rapid proliferative phase, in which collagen is formed, during the first 3 weeks. After 3 weeks the consolidation phase of recovery starts and this may explain the short drop in echogenicity we observed between 3 and 4 weeks.

Disclosure:

Work supported by industry: no.

012

Episcissors-60: A systematic review and meta-analysis

Dzivakova, V1; Khunda, A1; Ballard, P1

1: James Cook University Hospital

Introduction: NHS England has chosen Episcissors-60 as one of the products included in the accelerated adoption programme. The evidence for its effectiveness is scanty.

Objectives: We aimed to compare risk of Obstetric Anal Sphincter Injury (OASI) and post suturing episiotomy angle amongst women who had undergone mediolateral episiotomy with Episcissors-60 versus those who had a mediolateral episiotomy with other scissors by systematically reviewing the literature and pooling the data in a meta-analysis.

Methods: Electronic search was performed in Medline database from database inception to July 2017. The search word used was ‘episcissors-60’ or ‘episcissors 60’. The search was restricted to ‘humans’ and ‘females’. No language or age group restrictions were applied. Studies were eligible if patients who had episiotomies with Episcissors-60 were compared to parallel or historic patients who had episiotomy with other scissors.

Results: Of 17 citations, five were eligible for inclusion in the review, but two studies required clarifications from authors which we were unable to obtain, therefore only three were included in the meta-analysis. There was one randomized prospective cluster study whereas others were service evaluations and before-after studies. The number of participants in each study ranged from 63 to 4314. In the meta-analysis Episcissors-60 didn’t significantly reduced OASI in deliveries in which episiotomies were performed, however it showed a trend towards reduction (OR= 0.61. 95% CI 0.33-1.13, p=0.12, I2= 0%), (Fig. 1).

figuref

Fig. 1: The odds ratio of OASI in deliveries with Episcissors-60 compared with deliveries with episiotomies by other scissors.

However, Episcissors-60 did reduce the overall risk of OASI in the whole population when introduced to an obstetric unit (in the total number of deliveries). OR 0.77. 95% CI 0.60-0.99, p=0.05, I2= 0% (Fig. 2).

figureg

Fig. 2: The odds ratio of OASI in the total obstetric population before and after introduction of Episcissors-60.

Only one study compared post-delivery suture angle before and after using of Episcissors-60 while others just measured angle after using of Episcissors-60. The reduction of the overall risk of OASI in the total number of deliveries from two studies was not associated with an increase in episiotomy rate; OR 1.08 (0.93, 1.25), P= 0.33.

Conclusions: We reported the first systematic review on the effect of Episcissors-60 on reducing OASI rate. Although the studies are of small size and low quality, the results are promising in terms of a positive effect of Episcissors-60 in preventing third and fourth degree tears in the whole population. This points to a Hawthorne effect. We await further publications in order to update our meta-analysis.

Disclosure:

Work supported by industry: no.

013

First vaginal delivery after caesarean section: Risk of severe perineal trauma

O'Leary, B1; Nolan, C1; Ciprike, V1

1: Our Lady of Lourdes Hospital, Drogheda

Introduction: Injury to the anal sphincter at delivery remains one of the leading causes of faecal incontinence in women1. Previous studies have reported an increased incidence of anal sphincter injury in women attempting a vaginal birth after caesarean (VBAC)2. This increased risk may be attributable to more propulsive uterine contractions in this group, despite an essentially primiparous perineum2.

Objective: To investigate risk factors for obstetric anal sphincter injury (OASI) in nulliparous women and secundiparous women attempting VBAC.

Methods: We conducted a retrospective analysis of all vaginal deliveries in nulliparous and secundiparous women with a previous caesarean delivery over a 10-year period from 2008 to 2017. A multiple logistic regression model was created using the presence of OASI as the dependent variable. Coefficients were adjusted for relevant maternal, fetal, and intrapartum risk factors. Statistical analysis was performed using R 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).

Results: During the study period there were 539 successful VBACs in secundiparous women and 8484 vaginal deliveries in nulliparous women. Women having a VBAC were not at a greater risk of anal sphincter injury than nulliparous women having a vaginal delivery over the same period (2.97% [16/539] versus 3.5% [271/8484], OR 1.08, 95% CI 0.65 – 1.80, P = 0.8704). Mothers in the VBAC group were older (31.2 ± 4.7 versus 27.7 ± 5.5 years, P = 0.001), delivered earlier (39.3 ± 1.9 versus 39.5 ± 1.6 weeks, P = 0.003), and had higher use of epidural analgesia (49.5% [267/539] versus 41.0% [3479/8484], P < 0.001). There was no difference in the rate of instrumental delivery (48.4% [261/539] versus 44.1% [3738/8484] P = 0.053], birthweight (3421 ± 486g versus 3444 ± 539g, P = 0.339), or episiotomy (46.8% [252/539] versus 45.1% [3825/8484], P = 0.478) between the two groups. Factors that increased the risk of OASIs on regression analysis were forceps delivery (OR 3.76, 95% CI 2.44 – 5.80, P = 0.001) and birthweight (OR 1.01, 95% CI 1.01 – 1.02, P = 0.0001). Epidural analgesia reduced the risk of sphincter injury (OR 0.61, 95% CI 0.46 – 0.80, P = 0.001), as did episiotomy (OR 0.68, 95% CI 0.48 – 0.97, P = 0.034). Vacuum extraction, gestational age, maternal age, and length of labour did not significantly change the risk of OASI (Table 1).

Conclusions: Women attempting VBAC in our institution do not appear to be at any greater risk of OASI when compared to nulliparous women. This difference from previous studies2 may be site-specific and further research is required for clarification before these results form part of our patient counselling.

Table 1. Multiple logistic regression model comparing mothers with anal sphincter injury with those with an intact sphincter.

figureh

References:

1. Dietz HP, Wilson PD, Milsom I. Maternal birth trauma: why should it matter to urogynaecologists? Curr Opin Obstet Gynecol. 2016 Oct;28(5):441–8.

2. Hehir MP, Fitzpatrick M, Cassidy M, Murphy M, O’Herlihy C. Are women having a vaginal birth after a previous caesarean delivery at increased risk of anal sphincter injury? BJOG. 2014 Nov;121(12):1515–20.

Disclosure:

Work supported by industry: no.

014

The effect of a mediolateral episiotomy on the recurrence of obstetrical anal spincter injury(OASI): An analysis of a national registry

van Bavel, J 1 ; Ravelli, A 2 ; Abu-Hanna, A 2 ; Mol, B 3 ; Roovers, J 4 ; de Leeuw, J 5

1: Department of Obstetrics and Gynecology, Amphia Hospital Breda, The Netherlands; 2: Department of Medical Informatics, Academic Medical Center, Amsterdam, The Netherlands; 3: The Robinson Research Institute, School of Medicine, University of Adelaide,the South Australian Health and Medical Research Institute Adelaide, Australia; 4: Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands; 5: Department of Obstetrics and Gynecology, Ikazia Hospital, Rotterdam, The Netherlands

Introduction: Women with obstetrical anal sphincter injury (OASI) in the first delivery have an increased risk for the recurrence of OASI (rOASI) in their second delivery and an increased risk of faecal incontinence in later life.1 A recent meta-analysis identified several risk factors for rOASI but was unable to address the role of mediolateral episiotomy (MLE) in the possible prevention of rOASI.2

Objective: To assess the effect of a MLE on the risk for rOASI in women who sustained an OASI in their first delivery.

Methods: We performed a cohort study using data from the Netherlands Perinatal Registry (www. perined.nl), containing information on almost all deliveries in the Netherlands from 2000-2009. A longitudinal probabilistic linkage procedure was performed to create a cohort with complete data on first and second deliveries of the same mother. Details of this linkage procedure were described earlier.3 We studied 391 026 women with a first and second delivery. After exclusion for multiple gestation, preterm delivery (<37 weeks), stillborn pregnancy, non-cephalic position and a caesarean section in the 1st or 2nd delivery, 259 662 women were identified in the database. OASI occurred in 9941women in their first delivery and these women were included in the analysis. The primary outcome was rOASI and the effect of a MLE on rOASI in all women, and separately analysed in women with a spontaneous vaginal delivery (SVD) and in women with an operative vaginal delivery (OVD). Univariate analysis was performed with the Student t test and chi-square test, as appropriate, to compare baseline characteristics. Multivariate logistic regression analysis was performed to control for possible confounding risk factors known from the literature.

Results: The rOASI rate in this cohort was 5.8%, compared to an OASI rate of 3.8% in their first delivery. Univariate analysis showed that post term pregnancy and birthweight over 4000 grams significantly increased the risk of rOASI, whereas low socio-economic status and the use of MLE were associated with an significant lower risk for rOASI. After multivariate analysis including all 9941 women, MLE appeared to be associated with a significantly lower risk for rOASI (OR 0.35, 95% CI: 0.29 – 0.44). Separate multivariate analysis of 9707 women with SVD showed that MLE was able to lower the risk for rOASI significantly, with an odds-ratio of 0,36 (95% CI: 0.30 – 0.45). The rate of rOASI dropped from 7.6% to 3.1%. The calculated number of MLE needed to prevent one rOASI in these women was 22. In 234 women with OVD the protective effect of MLE was even more pronounced with an odds ratio of 0.17 (95% CI: 0.05 – 0.53). In these women the rate of rOASI was 14.8% without and 2.8% with the use of MLE. The number of MLE to prevent one rOASI during OVD was 8.

Conclusions: Mediolateral episiotomy is an independent protective intervention for the recurrence of OASI, especially in women delivered with an OVD

References

  1. 1.

    Am J Obstet Gynecol. 2017 Jun;216(6):610.e1-610.e8.

    2.Int Urogynecol J. 2016 Jun;27(6):849-57.

    3.Am J Obstet Gynecol. 2012 Oct;207(4):279.e1-7.

Disclosure:

Work supported by industry: no.

015

A prognostic model to determine the risk of obstetric anal sphincter injury (OASI) in low-risk women delivering on land and in water

Preston, H 1 ; Alfirevic, Z 2 ; Lane, S 2 ; Fowler, G 1

1: Liverpool Women's Hospital; 2: University of Liverpool

Background: Water immersion during labour has become increasingly popular amongst women who desire an intervention-free, patient-controlled birth1. Although known to be safe for the neonate, a small number of studies have identified water birth as a risk factor for obstetric anal sphincter injury (OASI)2,3. These studies have used heterogeneous groups of women including those undergoing medical intervention.

Aims:

  • To determine if water birth is an independent risk factor for OASI

  • To create a prognostic model to quantify OASI risk in low risk women delivering without medical intervention on land or in water.

Method: A retrospective study of low risk women delivering vaginally in a midwife-led unit over a seven year period. Patient factors and delivery data were analysed to identify differences between land and water births and to assess risk factors for OASI. Logistic regression was performed and a prognostic model was created to predict OASI risk for a low risk woman dependent on whether they delivered on land or in water.

Results: Of 15,734 women, 14,490 delivered on land and 1,244 in water. Initial analysis showed a 3.3% rate of OASI after water delivery compared to 1.6% on land (OR 2.10, 95% CI: 1.5-2.94). Logistical regression analysis confirmed water birth as an independent risk factor for OASI. Factors influencing OASI risk (ethnicity, parity and length of active second stage) were used to create a prognostic model to predict likelihood of OASI on land and in water. The highest risk groups of women were Black and Asian primips delivering in water with a 9.7% and 7.2% OASI risk respectively. The lowest risk group was white multiparous women delivering on land with a 0.7% risk of OASI. The OASI risk in our most prevalent group of women, white primips, was 3.8% in water compared to 2.3% on land. An active second stage of between 45 and 60 minutes increased OASI risk of a white primip delivering in water to 5.0%, rising to 7.8% after 60-75 minutes. Full data will be presented at conference.

Conclusion: This study of a homogenous group of low-risk women shows an increased risk of OASI when delivering in water. This prognostic model can be used to create an app which will help advise low-risk women on their individual OASI risk.

References

1. Cochrane database Syst Rev. 2009;(2): CD000111.doi:10.1002/14651858.CD000111.pub3.

2. BMC Res Notes. 2014;7:471. doi:10.1186/1756-0500-7-471.

3. Eur J Obstet Gynecol Reprod Biol. 2011;155(1): 27-30. doi:10.1016/j.ejogrb.2010.11.012.

Disclosure:

Work supported by industry: no.

016

Incidence of perineal pain following spontaneous vaginal childbirth: a systematic review and meta-analysis

Manresa, M 1 ; Pereda-Núñez, A 2 ; Bataller-Sánchez, E 3 ; Ismail, KM 4 ; Webb, SS 5

1: Hospital General de Granollers ; 2: Hospital General de Granollers; 3: Hospital Clínic i Provincial de Barcelona; 4: University of Birmingham; 5: Birmingham Women's and Children's NHS Foundation Trust

Introduction: Postpartum Perineal pain is one of the most frequent complain at short term. However, the relationship between spontaneous vaginal delivery and perineal pain is not well defined.

Objective: A systematic review to determine the incidence of perineal pain related to intact perineum, first and second degree perineal trauma and episiotomy after spontaneous vaginal delivery.

Methods: Medline, EMBASE, CINAHL and MIDIRS databases were searched from inception to December 2017 using MeSH, and appropriate search terms to capture all studies using absorbable material and continuous technique for repair of at least one layer. Randomised Controlled Trials (RCTs) and Non-Randomised Studies (NRSs) were included. Case series and case reports were excluded.

Results: 13 studies, involving 3188 women, satisfied inclusion criteria (7 RCT and 6 NRSs). Risk bias and the quality of the included studies were assessed using validated methods. Quality assessment of the included RCTs showed that only 4 out of 7 studies met ≥ 50 quality assessment criteria. Regarding NRSs, all of the included studies met ≥ 50 quality assessment criteria. However, only one study reported pain for second degree perineal injury independently and six studies combined second degree trauma and episiotomy into one category. No studies were excluded from systematic review for failure to meet quality criteria. For the time periods of pain assessment 54% of the included studies reported perineal pain at 0-2days whilst only 38% of the studies reported pain at 10 days. Follow-up at 6 weeks and 3 months was reported by 23% of the studies and only 8% of the studies reported perineal pain at six months postpartum. We undertook a metanalysis of data from 1746 out of 3188 included women. Heterogeneity between studies regarding trauma classification, repair methods, parity and reporting mechanisms, was the reason for our inability to pool data. Meta-analysis was complicated due to the diverse nature of the included studies that resulted in high heterogeneity (I2 ≥ 60). It demonstrated that the incidence of perineal pain at 0-2 days for an intact perineum was 53%(n=434)(95%CI,37%-75%), an incidence that is higher than that in women who sustained a second degree tear 34%(n=208)(95%CI,37%-75%). For women whose second degree perineal injury/episiotomy was sutured in continuous repair technique of all layers, incidence at 10 days postnatal was 20%(n=90)(95%CI,12%-31%), however incidence increased to 25%(n=105)(95%CI,10%-64%) when only vaginal mucosa was sutured with continuous technique.

Conclusions: This is the first systematic review for the incidence of perineal pain following spontaneous vaginal childbirth. A significant number of included studies are limited by their sample sizes and methodological qualities. Heterogeneity between studies hindered our ability to undertake a comprehensive synthesis of the available evidence. Moreover, although the incidence of perineal pain after spontaneous childbirth during the first days postnatal is high, the follow-up period for these women in the longer term is very low. Consequently, the incidence of perineal pain for women following spontaneous childbirth remains unclear.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Boston Scientific, Promedon, Astellas).

017

Contribution to the development of an innovative Clinical Decision Support System to optimize childbirth outcomes

Oliveira, D 1 ; Parente, M 1 ; Mascarenhas, T 2 ; Natal, R 3

1: INEGI - LAETA; 2: FMUP - São João Hospital; 3: INEGI - LAETA - FEUP

Introduction: Personalized medicine is widely recognized as a key field in Healthcare due to its potential to predict disease progression, and quantitatively assess risk factors in a patient-oriented context. The present work intends to contribute to the development of a clinical decision support system to optimize childbirth outcomes. The improvements predict a decrease both in the number of cesareans and in the vaginal birth related injuries, thus avoiding pelvic floor dysfunction.

Objective: This work is intended to show the importance of using morphing algorithms to adapt the biocomputational models already constructed based in measurements of key structures obtained during an obstetric appointment.

Mehtods: Application of morphing algorithms to geometrical model required for computer simulations. Morphing transforms the surfaces and volumes of the original model into a new position or shape while preserving the topology.

To understand the influence of different geometries, vaginal deliveries were simulated considering the same pelvis and a fetus of 37 weeks of gestation and another one of 40 weeks of gestation. The childbirth simulations were conducted with the fetus in vertex presentation and occipito-anterior position. The vertical descent of the fetus, and the flexion/extension of the fetal head were controlled. The adaptation of the fetus to the diameters of the birth canal was not imposed. Indicators of the likelihood of successful delivery (forces, stresses and deformations) were analyzed.

Results: Fig 1 shows the morphing of the models used for computer simulations. The morphing algorithm was successfully used since the exact shape wanted was obtained. The same approach could be used for different pelvis shapes (gynaecoid, android, etc).

Fig. 1 – Biocomputational model for dimensions' adjustment. (a.) The landmarks on the initial shape of the pelvis and the diameters to be defined (diameters of the anterior superior and inferior iliac spines). (b.) Final shape of the pelvis. (c.) The landmarks on the initial shape of the fetus and the fetal head diameters (occipitofrontal and biparietal diameters). (d.) Final shape of the fetus.

figurei

Regarding childbirth simulations, it is noted that a difference of 3 weeks of gestation can drastically changes the delivery outcomes. The forces opposing the fetal descent were more than 50% higher when the labor occurred at 40 weeks, compared to a delivery at 37 weeks (Fig. 2). It was also verified that the engagement of the fetal head is a very important stage in the birthing process, and a good fit can result in lower values of muscular stresses and deformations, and lower values of opposing forces.

Fig. 2 – Forces against fetal descent during vaginal delivery considering a fetus of 37 weeks of gestation (37 W) and a fetus of 40 weeks of gestation (40 W).

figurej

Conclusions: The development of a clinical decision support system based on a personalized biomechanical analysis is an important contribution of this work. This system will give a virtual estimation of the chances that there is no foreseeable biomechanical problem for the baby delivery. Since the inputs of the system are biomechanical simulations, it may contribute also to medical training.

Disclosure:

Work supported by industry: no.

018

Pelvic organ prolapse in nulliparae

Chavez- Coloma, L1; Friedman, T2; Turel, F2; Dietz, HP2

1: 1Dr.Jose R. Reyes Memorial Medical Center, Department Of Obstetrics and Gynecology, ManilDr.Jose R. Reyes Memorial Medical Center, Department Of Obstetrics and Gynecology, Manila, Philippines; 2: University of Sydney

Introduction: Pregnancy and childbirth are thought to be the strongest environmental risk factors for female pelvic organ prolapse (POP). (1) POP does occur in nulliparae, although much less commonly, and it does not seems to have been exhaustively investigated to date.

Objectives: In this observational study, we attempted to determine the prevalence of signs and symptoms of prolapse amongst nulliparous women presenting to a Urogynaecology unit and to describe findings on prolapse assessment by clinical examination and translabial ultrasound (US).

Methods: This is a retrospective analysis of 375 vaginally nulliparous women seen routinely at two tertiary Urogynaecological centers between November 2006 and June 2017. All patients underwent a standardized interview, clinical examination and 3D/4D translabial US with Voluson 730 expert and Voluson E6 systems. (2) Volume datasets were retrieved and analysed by the first author, blinded against all clinical data. Pelvic organ descent measurements on maximum valsalva were obtained offline, using postprocessing software on a PC.

Results: Of 4297 women seen in the unit during the inclusion period, 409 were vaginally nulliparous. As 41 volume datasets were incomplete or missing, our analysis includes the remaining 368 women. 184 had exclusively delivered by Cesarean Section (CS), and 184 had had no pregnancies beyond 20 weeks’ gestation. Mean age was 48 (14-89) and mean BMI 29 (16-64). Prolapse symptoms were reported by 81 (22%). 106 women (29%) had clinically significant prolapse on POPQ (>= stage 2 for anterior/ posterior compartments and >= stage 1 for the central compartment) which was most commonly posterior (n= 70, 19%) compared to central (n=30, 9%) or anterior (n=63, 17%).

On imaging analysis, blinded against all other data, 64 (17%) women showed evidence of significant prolapse, and again the posterior compartment was most commonly affected (n= 47, 13%) compared to uterine descent (n= 12, 3%), and cystocele (n=14, 4 %). True rectocele (i.e. defects of the rectovaginal septum resulting in a diverticulum) was even more common in 69 (19%), although many were relatively high; i.e., they did not reach the cut- off for significant posterior compartment prolapse on US. When comparing women after CS births with nulliparae, no significant differences were found between groups for any of the tested measures (see Table).

Parameter   CS only (n=184) No births (n= 184) Univar. P Adj. P
Symptoms of prolapse 81 (22%) 47 (26%) 34 (18%) 0.097 0.207
Sign. prolapse on POPQ 106 (29%) 59 (32%) 47 (26%) 0.147 0.455
Anterior stage 2 or higher 63 (17%) 38 (21%) 25 (14%) 0.07 0.083
Central stage 1 or higher 30 (9%) 14 (8%) 16 (9%) 0.076 0.646
Posterior stage 2 or higher 70 (19%) 43 (23%) 27 (15%) 0.035 0.476
Significant prolapse on US 64 (17%) 32 (17%) 32 (17%) 0.342 0.982
Significant cystocele on US 14 (4%) 9 (5%) 5 (3%) 0.287 0.7
Sign. uterine descent on US 12 (3%) 11 (6%) 12 (7%) 0.84 0.943
Sign. rectal descent on US 47 (13%) 27 (15%) 19 (10%) 0.202 0.702
True rectocele on US 69 (19%) 41 (22%) 27 (15%) 0.065 0.066

TABLE. Signs and symptoms of prolapse amongst 368 vaginally nulliparous women. Univariate and multivariate logistic regression, the latter accounting for the effect of age, BMI, chronic constipation and obstructed defecation.

Conclusion: Pelvic organ prolapse is not rare in nulliparae, but it shows some peculiar characteristics. Significant cystocele seems to be uncommon in nulliparae, as opposed to posterior compartment descent and true rectocele on imaging. There are no substantive differences in symptoms, clinical or imaging signs of prolapse between women delivered exclusively by CS and nulliparae. Our findings imply that there is no consistent long term effect of pregnancy (as opposed to vaginal childbirth) on symptoms and signs of prolapse.

References:

1. Ultrasound Obstet Gynecol 2007; 30:81-85

2. Ultrasound Obstet Gynecol 2016; 60: 58-81

Disclosure:

Work supported by industry: no.

019

What is 'vault prolapse'?

Trutnovsky, G 1 ; Robledo, K 2 ; Shek, KL 3 ; Dietz, HP 4

1: Medical University of Graz, Austria; 2: Clinical Trials Centre, University of Sydney, Australia; 3: Liverpool Clinical School, University of Western Sydney, Australia; 4: University of Sydney

Introduction: The prevalence of pelvic organ prolapse (POP) is increasing due to changing demographics.(1) While normal pelvic organ support has been defined for women with intact uterus, (2) this is not the case for post- hysterectomy vault descent. A recent systematic review found that definitions of apical prolapse are highly variable, causing problems for research and clinical practice.(3)

Objective: To investigate the relationship between prolapse symptoms and apical POP-Q measurements and establish cutoffs for predicting prolapse symptoms using receiver–operating characteristics (ROC) curves.

Methods: This was a retrospective analysis of patients seen for assessment of lower urinary tract or pelvic floor disorders between March 2011 and December 2017 in a tertiary urogynaecological unit. Evaluation included a standardized interview and clinical assessment (Pelvic Organ Prolapse Quantification [POP-Q]). Symptoms of prolapse were ascertained as “sensation of a lump or a bulge” and/ or a “dragging sensation”. For analysis, the POP-Q measure „C“ relating to the position of cervix or vault, was regarded as the explanatory variable, with symptoms of prolapse the outcome measure. Receiver–operating characteristics (ROC) curves were prepared for women with and without hysterectomy. Areas under the ROC curve (AUC) were calculated as a measure of predictive performance, and cutoffs were determined.

Results: The records of 3010 women presenting during the study period were available for analysis. Mean age was 56.9 (SD 13.5, 17-89) years, with 64.4% (n= 1937) postmenopausal; mean body mass index (BMI) was 29.1 (SD 6.4, 14 – 68). Median parity was 2 (0-9) with 89.5% vaginally parous. Previous hysterectomy was reported by 947 women (31.5%), and 690 (22.9%) had previous prolapse and/or incontinence surgery. Prolapse symptoms were reported by 52.3% (n=1573). On clinical examination the following POP-Q measures were recorded: “C”: mean -4.3 (SD 2.9, -11 to 15); “Ba”: mean -0.7 (SD 1.7, -3 to 8), “Bp”: mean -1.1 (SD 1.4, -3 to 9). To control for multi-compartment prolapse, women with dominant prolapse in anterior or posterior compartments, defined as POP-Q >=2 stages higher than uterine/ vault prolapse, were excluded, leaving 2050.

figurek

Figure: ROC curves for apical descent as a test for symptomatic prolapse. Bold lines define cutoff (C=-5). (A) women with uterus in situ, (B) women after hysterectomy. After exclusion of women with dominant prolapse in other compartments, similar results were obtained in women with uterus in situ (C) and after hysterectomy (D) (n=2050).

In the full population (n=3010), we determined cut- offs for ‘significant prolapse’ of C= -5 for women with uterus in situ (sensitivity 0.59, specificity 0.74) and after hysterectomy (sensitivity 0.45, specificity, 0.82), with a cut-off of -5.5 performing marginally better (sensitivity 0.67, specificity 0.61) after hysterectomy. We repeated this analysis after exclusion of dominant prolapse in other compartments. For prediction of prolapse symptoms in this subgroup (n= 2050), cutoffs were set at C= -5 (sensitivity 0.73, specificity 0.67) and after hysterectomy (sensitivity 0.59, specificity, 0.73).

Conclusions: A previously proposed cut- off for ‘significant central compartment descent’ of 5 cm above the hymen (-5) on Valsalva seems valid regardless of whether ‘C’ refers to post- hysterectomy vault or uterus.

References:

1. JAMA 2008; 300: 1311-1316.

2. Int Urogynecol J 2014;25: 451-455

3. Am J Obstet Gynecol 2017; 216: 232

Disclosure:

Work supported by industry: no.

020

Post hysterectomy pelvic organ prolapse in a Dutch population; what is the true prevalence? (POP-UP study)

Vermeulen, C 1 ; Veen, J 1 ; Adang, C 1 ; Bongers, M 1

1: Máxima Medical Centre

Introduction: Hysterectomy is a risk factor for pelvic organ prolapse (POP), which can seriously discomfort women at any age and often results in surgical repair. In the available literature, the prevalence of POP after hysterectomy was measured using POP surgery data from national databases, therefore underestimating the true POP prevalence. Long-term studies for POP after laparoscopic hysterectomy (LH) have not been performed. The uterosacral ligaments are of major importance for level one pelvic organ support. Since they are not harmed during LH contrary to vaginal hysterectomy (VH), this might reduce the risk for vault prolapse when performed for the same, benign indication.

Objective: The primary objective of this study is to review the prevalence of POP after LH compared to VH, after a follow up of 12 to 20 years.

Methods: We included patients who underwent LH or VH in a single center in the period of 1996 to 2004. A questionnaire was sent regarding prolapse treatment (conservative and surgical), pelvic floor complaints (PFDI20) and risk factors for POP. The presence of POP was assessed using the POP-Q.

Results (preliminary): We invited 728 patients, of which 420 (57.7%) responded the questionnaire and 258 (35.4%) gave consent for POP-Q examination. For accurate analysis, we divided patients into three groups: LH (questionnaire n=177, POP-Q n=108), VH-1 (VH for benign indication other than prolapse, questionnaire n=103, POP-Q n=58) and VH-2 (VH for prolapse, questionnaire n=140, POP-Q n=92). Baseline characteristics regarding age and obstetric history were the same. After hysterectomy, 70 patients in total (16.7%) received any treatment for prolapse, which was 19 (10.7%), 13 (12.6%) and 38 (27.1%) respectively for the LH-group, VH-1 group, and VH-2 group. No difference in pelvic floor complaints was found between patients with a LH and VH1 (median score of PFDI-20 of 22.9 and 31.3 respectively), but between VH-2 versus LH and VH-1 a significant difference was measured (p=0.006). The prevalence of vaginal vault prolapse (≥ stage 2) was 2.8% for LH patients and 3.4% for VH-1 patients, which was not significantly different. The prevalence of any prolapse (anterior, apical or posterior compartment, ≥ stage 2) was 151 (57,8%) in total; 44.4% for the LH-group, 51.7% for the VH-1 group (LH versus VH-1 is not significantly different; p=0.37) and 79.3% for the VH-2 group. 49% of the pelvic organ prolapse was asymptomatic. The positive predictive value of POP symptoms for anatomic POP is 67%.

Conclusions (preliminary): This is the first study reporting on the prevalence of POP following LH using both symptoms and POP-Q. The prevalence of anatomic POP after hysterectomy is 57.8% after median follow-up of 17 years. The prevalence of symptomatic POP after hysterectomy is 29.8%. POP after vaginal hysterectomy for prolapse occurs 1.7 times (RR; 95% CI 1.39 – 2.04, p < 0.0001) more frequent than after hysterectomy for other benign indications. No difference was found in the incidence of vaginal vault prolapse between LH and VH for benign indication other than prolapse.

These results are preliminary; we are awaiting the response of a reminder (both questionnaire and POP-Q exam). We expect to finish inclusion at the end of March 2018. We will correct our data for age, BMI and parity.

Disclosure:

Work supported by industry: no.

021

Do height, weight and BMI affect the relationship between symptoms and signs of prolapse?

Friedman Barhum, T 1 ; Dietz, HP 1

1: Sydney University

Introduction: Studies have shown an association between BMI and pelvic organ prolapse, (1) mainly for posterior compartment descent (2). It is however conceivable that higher grades of obesity reduce the likelihood of individuals noticing a lump, either because of the impossibility of direct observation, or because distinction between a skin fold and prolapse may be difficult.

Objective: To evaluate whether BMI changes the relationship between signs and symptoms of prolapse.

Methods: This was a retrospective observational study based on archived datasets of women seen in a tertiary urogynecological centre with symptoms of pelvic floor and lower urinary tract dysfunction between April 2012 and October 2015. Patients underwent an interview, clinical examination (POP-Q) and 4D transperineal ultrasound (TPUS). Offline assessment of sonographic organ descent was undertaken at a later date, blinded to all patient data. Significant prolapse on clinical examination and TPUS was defined as previously described. (3) Statistical analysis (univariate and multivariate logistic regression) was performed using IBM v 24 SPSS software. Logistic regressions were compared using a likelihood ratio test (LRT).

Results: 1551 patients were seen during the inclusion period. Forty-six had to be excluded because of missing data, leaving 1505 for statistical analysis. Mean age was 56 (17-89) years, mean BMI 29 (15-64). At least one vaginal delivery was reported by 1387 patients. Prolapse symptoms were reported by 824 women. Clinically significant POP was detected in 1181 (75.9%) patients, including a cystocele in 877 (POPQ stage≥ 2), 265 cases of uterine prolapse (POPQ stage≥ 1), and 833 cases of significant posterior compartment descent (POPQ stage≥ 2). On TPUS, significant cystocele, uterine prolapse and rectocele were identified in 616, 300, and 625 cases, respectively. Analysis of the association between symptoms of prolapse on the one hand and height, weight and BMI on the other hand is shown in Table 1, with both weight and BMI being negatively associated with symptoms. In other words, the more obese the patient, the less she reported prolapse symptoms.

  Odds Ratio 95% Confidence Interval P value
Height 1.001 0.99-1.015 0.889
Weight 0.99 0.98-0.996 0.001
BMI 0.97 0.96-0.99 0.001

Table 1: Association between symptoms of prolapse and height,weight and BMI.

Analyzed by binary logistic regression.

We then undertook modelling for the association between symptoms of prolapse and anterior compartment descent (Ba), both with and without BMI, and compared the models using a likelihood ratio test (LRT). The Ba model with the inclusion of BMI was significantly superior at predicting symptoms of prolapse, compared to the model with Ba alone (LRT p-value<0.0001). The same was the case when replacing Ba with sonographic bladder descent (LRT p-value<0.0001).

Conclusions: Weight and BMI affect the relationship between symptoms and signs of prolapse, regardless of whether prolapse is diagnosed clinically or by imaging. This effect is statistically highly significant. The more obese a patient is, the less likely she is to notice a given degree of objective prolapse, regardless of whether it is diagnosed clinically or on imaging. This may have implications for counselling and clinical care.

References:

1.) Obstet Gynecol 2009; 113: 609-

2.) Int Urogynecol J 2017; doi.org/10.1007/s00192-017-3455-8

3.) Clin Obstet Gynecol 2017; 60: 58–81

Disclosure:

Work supported by industry: no.

022

De novo urinary incontinence after pelvic organ prolapse surgery

Khayyami, Y 1 ; Elmelund, M 1 ; Lose, G 1 ; Klarskov, N 1

1: Herlev Gentofte University hospital

Introduction: De novo urinary incontinence (UI) after pelvic organ prolapse (POP) surgery is a puzzling task for clinicians. Several clinical studies have investigated this problem (1), but we are still unsure of the extent of de novo UI, and if there are any factors that may put some women at a higher risk than others. Therefore, the preoperative counselling of women with POP may be a challenge.

Objective: To investigate the prevalence of de novo UI after POP surgery, and identify risk factors for de novo UI.

Methods: Data was collected from the Danish Urogynecological Database, a national database that contains data on all urogynecological procedures performed in Denmark (2). Inclusion criteria were urinary continent women who underwent POP surgery alone (no concomitant incontinence surgery, and no history of POP surgery, hysterectomy or incontinence surgery). A woman was defined as urinary continent if her ICIQ-UI-sf had an ICIQ score of 0 and she answered ‘never’ to ‘When does urine leak?’. Postoperatively, the women were categorized as either continent or women with stress urinary incontinence (SUI), urgency urinary incontinence (UUI), mixed urinary incontinence (MUI) or undefined UI, based on their ICIQ-UI-sf results. Data from hospitals which had a minimum 75% response rate in both pre- and postoperative ICIQ-UI-sf in the years 2013-2016 were included from the database. Statistical analyses included multivariate logistic regression analyses, for the outcome de novo UI. The included parameters were involved compartment/s during POP surgery, preoperative POP stage (POP-Q), BMI and age. P-values <0.05 were considered statistically significant.

Results: We included 1198 women. The overall risk of de novo UI after POP surgery was 15%; 45% had SUI, 30% had UUI, 16% had MUI, and 10% had undefined UI. Age, compartment and POP stage were not significantly associated with de novo UI (table 1). BMI was highly assosiated with de novo UI ; the risk of de novo UI was 12 % for women with BMI <25, 16% for women with BMI 25 – <30, whereas 23% of women with BMI ≥30 had de novo UI.

Table 1. Odds ratio for de novo urinary incontinence after POP surgery. Odds ratios are calculated based on the involving compartment/s, for POP stage, BMI and age.

Parameter n Odds ratio
(95% CI)
Univariate
p Odds ratio
(95% CI)
Multivariate*
p
POP surgery 1198     
Posterior compartment a 309 1.00 (ref)   1.00 (ref)  
Anterior compartment a 795 1.22 (0.83−1.80) 0.3 1.20 (0.80−1.81) 0.4
Anterior and posterior compartments a 94 1.64 (0.89−3.03) 0.11 1.59 (0.85−2.97) 0.15
POP stage 1160     
1-2 556 1.00 (ref)   1.00 (ref)  
3 574 1.12 (0.81−1.56) 0.5 0.99 (0.71−1.40) 1.0
4 30 1.21 (0.50−3.25) 0.7 0.95 (0.34−2.60) 0.9
BMI (per kg/m2) 1195 1.07 (1.03−1.11) <0.001 1.07 (1.03−1.11) 0.001
Age (per year) 1198 1.01 (1.00−1.02) 0.18 1.01 (0.99−1.02) 0.3

*Multivariate analyses including POP stage, BMI and age.

a With or without POP surgery in the middle compartment, which had no effect on the results.

Conclusions: The prevalence of de novo UI, including the subtypes of UI, after POP surgery is the same, regardless of the involved compartment/s. Surprisingly, POP stage does not seem to have any influence on de novo UI. However, BMI is significantly linked to the occurrence of de novo UI; twice as many women with BMI ≥30 had de novo UI, compared with women with BMI <25. These results may be of value in the preoperative counselling of women.

References:

1) Neurourol Urodyn. 2013 Jun;32(5):455–9

2) Int.Urogynecol J. 2013 Jun;24(6):983-90

Disclosure:

Work supported by industry: no, by Yasmine Khayyami.

023

Are all Cystoceles have the same structures failure pattern? 3D stress MRI-based heatmap and cluster analysis of muscular and fascia status

Chen, L 1 ; Swenson, C 1 ; DeLancey, J 1

1: University of Michigan

Introduction: Cystocele, or anterior vaginal wall prolapse (AVP), is the most common form of pelvic organ prolapse and, importantly, the most frequent site of operative failure. The pathomechanics of AVP involves mechanical interactions between three support systems: vaginal wall (SV), fascial attachments (SF), and levator ani muscles (SM). Among women with AVP, varying degrees of impairment in each of these three systems may occur in each of these three systems. Stress 3D MRI now allow quantification of the support systems in order to identify interaction patterns associated with AVP.

figurel

Objective: To use cluster analysis to identify patterns of structural failure in AVP, and to compare differences in the three support systems between AVP subtypes.

Methods: In this pilot study, 3D Stress MRI imaging of the pelvic floor at rest and during maximal Valsalva were acquired for 30 women with AVP and 30 women with normal pelvic support. Three supporting system were quantified including Sv (vaginal length, mid-vaginal width), SF (cervix height and lateral mid-vaginal height) and SM (urogenital hiatus size) using a newly developed stress MRI based measurement technique. A dendrogram hierarchical cluster analysis was used to explore the number of potential clusters in the pilot data. Bootstrapping simulation were performed to determine the optimal cluster number. Women with AVP were assigned into different clusters based on the final classification. ANOVA and post-hoc comparisons were performed for the three support systems in AVP subtypes and normal controls. Within each AVP cluster, we also use linear regression to evaluate the most significant parameters in determining prolapse size (lowest point in AW).

Results: The dendrogram hierarchical cluster analysis demonstrated at least two distinct clusters of AVP subtypes (Figure 1). The results from the elbow method, silhouette plot, and gap plot of bootstrapping simulations suggest two AVP subtypes are the optimal cluster number. Table 1. shows the comparison between these two AVP clusters and the controls. Compared to AVP cluster 2, AVP cluster 1 has higher cervix in SF, smaller genital hiatus size in SM and smaller prolapse size. Vaginal width in Sv also differed significantly between two subtypes with cluster 1 having smaller than normal vaginal width and cluster 2 having larger than normal vaginal width. In AVP cluster 1, prolapse size was most strongly associated with paravaginal support (mid-vaginal height in SF , r =0.864, p<0.0001), while in AVP cluster 2, apical support (cervix height in SF) was most strongly associate with prolapse (r=0.938, p<0.0001).

figurem

Conclusions: We have identified two distinct AVP subtypes with different characteristics of the vaginal, fascial, and muscular support systems. Having established these different patterns, different underlying pathomechanisms and their differential response to surgical interventions can be explored.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Hologic, Johnson &amp;amp; Johnson).

024

Comparing minimally invasive sacrocolpopexy to uterosacral ligament suspension- a multicenter cohort study through Fellows’ Pelvic Research Network

Noor, N 1 ; Bastawros, D 2 ; Florian-Rodriguez, M 3 ; Hobson, D 4 ; Lozo, S 5 ; Lavelle, E 6 ; Haviland, M 7 ; Antosh, D 8 ; VonBargen, E 9

1: Mount Auburn Hospital; 2: Carolina Medical Center; 3: University of Texas Southwestern; 4: University of Louiseville; 5: Northshore Medical Center; 6: University of Pittsburg; 7: Beth Israel Deaconess Medical Center; 8: Houston Methodist Hospital; 9: Massachusetts General Hospital

Introduction: There is limited data comparing minimally invasive sacrocolpopexy (MISC) to vaginal uterosacral ligament suspension (vUSLS) despite both procedures providing the benefits of a minimally invasive technique.

Objective: Our aim was to compare anatomic outcomes one year after surgery between patients who underwent MISC (laparoscopic or robotic) with synthetic mesh to those who underwent vUSLS for management of pelvic organ prolapse (POP). Secondary outcomes included comparing intra and postoperative complications.

Methods: This was a multi-center, retrospective cohort study through the Fellows Pelvic Research Network involving 7 academic institutions in the United States with fellowship training in Female Pelvic Medicine and Reconstructive Surgery. Patients with stage 2 or greater POP who underwent apical suspension with MISC or vUSLS from January 2013 to January 2016 with at least one-year postoperative anatomic data were included. Patients with prior apical repairs, prior vaginal repairs with biologic/synthetic graft, or history of connective tissue disorders were excluded. Eligible patients were identified using Current Procedural Terminology (CPT) codes. Relevant pre, intra, and postoperative data was abstracted from medical records. Failure at one year was defined as the leading edge of the anterior or posterior compartment beyond the hymen (Ba or Bp > 0) or the descent of the cervix/vaginal cuff beyond the mid-vagina (C > -TVL/2). Categorical data were compared using chi-square and Fisher’s exact tests, and continuous data were compared using the Wilcoxon rank sum test.

Results: During the study period, 337 eligible patients underwent MISC (171 laparoscopic and 166 robotic) and 165 patients underwent vUSLS. The majority of patients had stage 2 or 3 POP. At one year postop, there was no difference in apical failure between the two groups: 10 (3%) in MISC and 5 (3%) in the vUSLS (p=1.0). However, failure in the anterior compartment (Ba > 0) was lower in the MISC group: 7 (2.1%) versus 9 (4.5%) in vUSLS group, (p=0.04). Posterior compartment failure (Bp > 0) was similar between the two groups: 8 (2.3%) in MISC group and 1 (0.7%) in the vUSLS and (p=0.45). Operative time was longer in MISC group (P=0.01) but perioperative urinary dysfunction (p=0.003) and fever (p=0.02) were higher in the vUSLS group. Seven patients in the MISC group had mesh/suture exposure and 10 patients in the vUSLS group had suture exposure (p= 0.048). Postoperative pelvic pain, dyspareunia, voiding and bowel dysfunction were comparable in the two groups.

Conclusion: At one-year follow-up, women who underwent MISC or vUSLS had similar apical vaginal support. However, there were more anterior vaginal compartment failure in the vUSLS group. Both procedures had a low complication rate including mesh or suture exposure.

Disclosure:

Work supported by industry: no.

025

Does sacrocolplopexy present heterogeneity with regard to its surgical technique? A systematic review

Mendes Moroni, RM1; Juliato, C2; Cosson, M3; Giraudet, G3; Oliveira Brito, LG2

1: University of São Paulo; 2: University of Campinas; 3: Hopital Jeanne de Flandres, CHRU Lille, France

Introduction: Sacrocolpopexy (SCP) is considered the gold standard for treatment of female pelvic organ prolapse (POP); however, there is great heterogeneity on its technical aspects among various trials.

Objective: To analyze the technical steps for performance of SCP among all RCTs in the literature that compared it with different procedures or that studied different routes for performing SCP.

Methods: Systematic review at MEDLINE, EMBASE and Scielo databases. We extracted data from the reports with special interest in the following 12 items – procedure standardization; surgeon expertise; perioperative estrogen; preoperative antibiotics; bladder catheterization regimen; depth of vaginal dissection; number of sutures in the vaginal wall; type of suture or material in the vaginal wall; type of mesh fixation to the sacrum; type and shape of mesh used; use of mesh peritonealization; use of intra-operative cystoscopy.

Results: We have included 22 RCTs that studied SCP (Figure 1). Studies are described in Table 1.

figuren

Figure 1 – PRISMA flowchart of study inclusion

Some form of standardization was said to take place in 16/22 studies; in 15/22 all surgeries were only performed by highly experienced surgeons, while in 2/22 surgeries were performed by fellows; use of perioperative estrogen has only been described by 2 studies; 5/22 stated that preoperative antibiotics were used; 7/22 included a bladder catheterization regimen, all using transurethral Foleys from 1 day up to 7 days. Vaginal dissection was described in 16/22 studies, with great variability – 7/22 performed a complete full-length anterior and posterior vaginal dissection, 2/22 performed 1/3 to 2/3 length dissection; 1/22 performed anterior-only deep dissection; 2/22 only dissected the posterior wall deeply; in 2/22 the dissection was very superficial and posterior-only; 2/22 performed anterior and posterior dissections without further details; 6/22 provided no description on extent of vaginal dissection. In 11/22 the number of vaginal sutures was stated, 4 to 6 stitches in each wall being the most common (5/22), with some studies employing larger numbers, up to 15 in each wall (2/22), while others employed a lower number, from a single suture (1/22) to 2 to 3 sutures (3/11). Mesh fixation to the vaginal wall was only done with sutures, 8/22 employing non-absorbable sutures (3/22 multifilament, 5/22 monofilament) and 7/22 using absorbable sutures (PDS being the most common); 7/22 did not specify the type of material used. Sacral fixation was also mostly performed by sutures (11/22, all non-absorbable); in 3/22 the use of non-absorbable sutures or

Figure 1 – PRISMA flowchart of study inclusion

staples / tacks was at discretion; 4/22 used staples / tacks only. Mesh material was most commonly polypropylene (11/22), with alternative materials being PVDF (1/22), PTFE (1/22), Polyester (1/22) and Biologic (2/22); in 4/22 more than one material was used. Mesh peritonealization was done in 14/22, and not stated in 7/22; one study left at surgeon’s discretion. Cystoscopy was performed in 4/22, and not performed in 1/22, with the rest unspecified.

figureo

Table 1 – Characteristics of included studies

Conclusions: SCP is a highly unstandardized procedure in the literature, albeit being used as a gold-standard comparator. Various RCTs compared alternative procedures with SCP, but the technical aspects have greatly diverged, and study outcomes could have been potentially influenced by these technical choices.

Disclosure:

Work supported by industry: no.

026

A randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS) – a pilot study to assess feasibility of a large multi-centre trial

Verghese, TS1; Middleton, LJ2; Cheed, V2; Leighton, L2; Daniels , JP3; Latthe , PM4

1: University of Birmingham; 2: Birmingham Clinical Trials Unit; 3: University of Nottingham; 4: Birmingham Women’s and Children’s NHS Foundation Trust

Introduction: Oestrogen deficiency in postmenopausal women leads to vaginal atrophy and might contribute to weakening of pelvic floor muscles resulting in pelvic organ prolapse (POP). A Cochrane review evaluated the effect of oestrogen as an adjunct in POP surgery and highlighted the sparse evidence in this field, recommending the need for randomised controlled trial (RCT) to determine the benefit/risk of oestrogen in this setting.

Objective: To evaluate the feasibility of a multicentre RCT comparing vaginal oestrogen treatment with no treatment in women undergoing POP surgery, with the aim of improving prolapse-related patient-reported outcomes.

Methods: A randomised parallel open external pilot trial involving six UK urogynaecology centres (July 2015- August 2016). Post-menopausal women with POP opting for surgery were recruited. Women were randomised (1:1) to pre and post-operative vaginal oestrogen or no treatment. Oestrogen treatment (oestradiol hemihydrate 10mcg vaginal pessaries) commenced 6 weeks prior to surgery (once daily for two weeks, twice weekly for four weeks) and twice weekly for 26 weeks from 6 weeks post-surgery. A matched placebo was not available. The main outcomes were assessment of eligibility and recruitment rates along with compliance and data completion. Prolapse related specific quality of life measures included the Pelvic Floor Distress Inventory- Short Form 20 (PFDI-SF20) and the Patient Global Impression of Improvement (PGI-I) (6/12 months). Clinical outcomes measured by POP Quantification system (at 6 months post) and post-operative complications.

Results: Of the 100 women 85 proceeded to surgery; comorbidities precluded 6 women from surgery, 3 patients withdrew and 6 patients failed to attend for surgery.

Figure 1: Flow diagram

325 women who wished prolapse repair surgery were screened over 13 months and 157 (48%) found to be eligible. Of these, 100 (64%) were randomised, 50 to oestrogen and 50 to no oestrogen treatment, with 85 (44/ 45 respectively) ultimately having surgery. Of these, 91% (77/85) returned completed symptom questionnaires at six months, 92% (79/85) at twelve months. Of the 41 women reporting compliance with the oestrogen regimen, 78% were deemed as good compliers. Overall, scores from the PFDI-SF20 (POPDI-6 domain) were low at both 6 and 12 months, averaging 14.3 (SD: 16.4) and 15.6 (18.1) out of a maximum of 100, indicating a low level of prolapse-related symptoms at these times. Responses from the PFIQ-7 (POP-IQ-7 domain) were similarly low. The number of participants reporting being improved (very much better or better) on the PGI-I was 92% (73/79) at 6 months and 89% (70/79) at 12 months

Conclusions: A large multicentre RCT of oestrogen versus no treatment is feasible as it is possible to randomise and follow up participants with high fidelity. Four predefined feasibility criteria were met. Compliance with treatment regimens is not a barrier. A larger trial is required to definitively address the role of peri-operative oestrogen supplementation

Disclosure:

Work supported by industry: no.

027

Human immunodeficiency virus in the setting of female pelvic medicine & reconstructive surgery: A multicenter retrospective cohort study

Petrikovets, A 1 ; Carlos, D 2 ; Perlman, B 3 ; Florian-Rodriguez, M 4 ; Bochenska, K 5 ; Eto, C 6 ; Lespinasse, P 3 ; Mahajan, S 1 ; El-Nashar, S 1 ; Crisp, C 7 ; Weber Lebrun, E 8

1: Case Western Reserve University School of Medicine/University Hospitals Cleveland Medical Center; 2: Albert Einstein College of Medicine; 3: Rutgers New Jersey Medical School; 4: UT Southwestern School of Medicine; 5: Northwestern University; 6: Emory; 7: TriHealth Good Samaritan Hospital; 8: University of Florida College of Medicine

Introduction: Over half of Human Immunodeficiency Virus (HIV) positive women are older than age 50 and similar to their peers, may require surgical correction of pelvic floor disorders. It is unclear if perioperative and postoperative complications in the HIV population differ from uninfected individuals.

Objectives: To determine whether HIV positive women who undergo pelvic reconstructive surgery (PRS) are at increased risk of perioperative and postoperative complications compared to HIV negative controls.

Methods: This was a multicenter, retrospective cohort study of HIV patients who underwent PRS between 2006-2016 within institutions participating in the Fellows’ Pelvic Research Network. Cases were identified using ICD 9/10 and CPT codes encompassing HIV diagnoses and pelvic reconstructive procedures. Only those procedures performed by Female Pelvic Medicine and Reconstructive Surgeons were included. Controls were identified as patients without HIV who underwent similar procedures, performed by the same surgeon, within one year of the HIV positive subject. A 1:3 case to control ratio was utilized; patients were matched to control for unmeasured confounders. The primary outcome was the complication rate within one year of surgery. Secondary outcomes included differences in composite complications, early complications, late complications, and pelvic floor disease recurrence and reoperation.

Results: 63 patients with HIV and 187 matched controls were identified from five institutions. The preoperative indications were similar except for cervical dysplasia, which was present in 15.9% of patients with HIV compared to 3.2% of those without HIV (P= 0.001). There was no difference in complication rates between HIV negative and positive women (26.7% vs 36.5%, P=0.15). Similarly, there was no difference in the number of composite complications in HIV patients during the same time frame compared to patients without HIV (Table 1). However, 19.1% of patients with HIV compared to 5.4% controls had Clavien Dindo Grade I complications (P=0.002), and 11.1% of HIV patients had urinary retention within 6 weeks of surgery compared to 3.2% of controls (P =0.02) (Table 2). After multivariable logistic regression was used to adjust for confounders, HIV positive status was not associated with an increased risk of complications (aOR=1.73, 95% CI: 0.90-3.34).

Conclusions: HIV positive status does not confer an increased risk of complications within one year of PRS compared to negative controls.

References:

1. Kirk JB, Goetz MB. Human Immunodeficiency Virus in an Aging Population, a Complication of Success. JAGS 2009; 57: 2129-2138.

2. Linley L, Hall H, An Q et al. HIV/AIDS Diagnoses Among Persons Fifty Years and Older in 33 States, 2001-2005. National HIV Prevention Conference. 2007; Atlanta, GA Abstract B08-1-1 P 136-137.

3. Samji H, Cescon A, Hogg RS, Modur SP, Althoff KN, et al. (2013) Closing the Gap: Increases in Life Expectancy among Treated HIV-Positive Individuals in the United States and Canada. PLoS ONE 8(12): e81355.

Table 1. Overall and Interval Period Complications   
Category HIV Positive (n=63) HIV Negative (n=187) P
Complication Rates OR to 1 year* 23 (36.5) 50 (26.7) 0.15
OR to 6 weeks 19 (30.2) 41 (21.9) 0.19
6 weeks to 6 months 2 (3.2) 7 (3.7) 0.83
6 months to 1 year 2 (3.2) 8 (4.3) 0.69
Composite OR to 1 year 0.5±0.7 0.4±0.7 0.14
OR to 6 weeks 0.4±0.7 0.3±0.6 0.16
6 weeks to 6 months 0.03±0.2 0.04±0.2 0.83
6 months to 1 year 0.03±0.2 0.04±0.2 0.7

Data are n (%), mean ± standard deviation unless otherwise mentioned.

*Patients with more than one complication are counted once.

Table 2. Early Complications, Disease Recurrence, and Clavien Dindo Grades (OR to 6 weeks)

Complication / Disease HIV Positive (n=63) HIV Negative (n=187) P
Bladder Injury 3 (4.8) 6 (3.2) 0.58
Anemia 3 (4.8) 3 (1.6) 0.19
Readmission 0 (0) 3 (1.6) 0.19
Wound Dehiscence 1 (1.6) 1 (0.5) 0.45
Transfusion 2 (3.2) 3 (1.6) 0.46
Surgical Site Infection 2 (3.2) 6 (3.2) 0.99
Reoperation due to Treatment Failure 1 (1.6) 1 (0.5) 0.45
Disease Recurrence 1 (1.6) 1 (0.5) 0.45
Infectious Morbidity not UTI 0 (0) 4 (2.1) 0.13
UTI 6 (9.5) 16 (8.6) 0.82
Urinary Retention 7 (11.1) 6 (3.2) 0.02
Respiratory Arrest 0 (0) 1 (0.5) 0.45
Seroma 0 (0) 1 (0.5) 0.45
Ileus 0 (0) 1 (0.5) 0.45
Clavien Dindo Grade    
I 12 (19.1) 10 (5.4) 0.002
II 9 (14.3) 29 (15.5) 0.81
IIIA 0 (0) 0 (0) -
IIIB 3 (4.8) 7 (3.7) 0.71
IV and V 0 1 (0.5) 0.45

Data are n (%), mean ± standard deviation unless otherwise mentioned

Disclosure:

Work supported by industry: no.

028

Mesh exposure and chronic pain after transvaginal mesh prolapse operations: out of permissible range?

Kato, K 1 ; Suzuki, S 1 ; Kawanishi, H 1 ; Nagayama, J 1 ; Matsui, H 1 ; Hirabayashi, H 1 ; Hattori, R 1

1: Japanese Red Cross Nagoya First Hospital

Introduction: Self-cut polypropylene mesh has been used for transvaginal mesh prolapse operations (TVM) in Japan since the mid 2000s. In 2011, the U.S. Food and Drug Administration (FDA) released a safety communication on mesh-related complications, and the number of TVM decreased in the U.S. and Europe thereafter. However, in Japan, serious discussions and hands-on training in medical societies have been useful in reducing TVM complications.

Objective: Investigating the prevalence of mesh exposure and chronic pain after TVM in a hospital with a high volume of prolapse operations.

Methods: Medical charts were retrospectively examined for 2,648 patients who underwent TVM in our hospital between 2006 and 2017. The majority of operations were conventional TVM (Prolift®-type, anterior mesh with upper and lower transobturator arms, posterior mesh with sacrospinous arms) with a shift from 2015 to modified TVM (Uphold®-type, small anterior mesh with sacrospinous arms). Patients were instructed to have at least 2 years of follow-up and to visit or report when they had problems regarding the operation. Chronic pain was defined as persistent pain for more than 3 months following the first 3 months from the time of operations.

Results: The prevalence of mesh exposure was 30/2,648 (1.13%); 17 vaginal, 8 bladder, 2 ureteral, and 3 rectal. Vaginal exposure was managed by either trimming at the outpatient clinic or transvaginal repair in the operating room. Bladder exposure with stone formation (OAB or cystitis symptoms 1-5 years postoperatively) was managed by transurethral resection with saline (TURis). Most of cases occurred by bladder perforation of the mesh arm during operation since intraoperative cystoscopy was not done routinely at first. Open ureterocystostomy was done to treat 2 cases of ureteral exposure with stone formation, and mesh arm incision and temporary ureteral stent insertion were performed in other 2 cases of ureteral stenosis. Rectal exposure (rectal bleeding 4, 5 and 8 years postoperatively) was managed by transvaginal repair; colostomy was not necessary. In one case, vaginal evisceration of small intestine occurred 5 months postoperatively, and was managed by emergency transvaginal repair. The prevalence of postoperative chronic pain was 12/2,648 (0.45%), and preoperative chronic pelvic pain was found in one third of them. They had pharmacological treatment, and 2 cases further had surgical treatment; in one case with bladder exposure, chronic pain was resolved with TURis, but in one case with tenderness on the mesh arm, pain did not improve after a mesh removal. Thus 34/2,648 (1.28%) had reoperation due to complications and only 2 cases (0.08%) needed open surgery. In 2015, we began to use modified TVM, and the 339 patients show no mesh exposure or chronic pain at present.

Conclusions: In this study, reoperation rate due to TVM complications were 1.28% which seems to be within permissible range. Several factors may contribute to this, such as knowing the proper dissection layer (Lychee layer), avoiding concomitant hysterectomy, and lower sexual activity among Japanese women. A shift to modified TVM without transobturator arms or posterior mesh will contribute to a further decrease in complications.

Disclosure:

Work supported by industry: no.

029

The vaginal microbiome after transvaginal mesh complications: a case-control study

Veit-Rubin, N 1 ; De Tayrac, R 2 ; Cartwright, R 3 ; Warembourg, S 2 ; Dunyach-Remy, C 4 ; Lavigne, J 4 ; Khullar, V 5

1: Department of Gynecology and Obstetrics, Medical University of Vienna; 2: Department of Gynecology and Obstetrics, Caremeau University Hospital, Nîmes, France; 3: Urogynaecology Department, Oxford University Hospitals, UK; 4: Department of Microbiology, Caremeau University Hospital, Nîmes, France Institut National de la Santé et de la Recherche Médicale, U1047, University of Montpellier, Nîmes, France; 5: Department of Urogynaecology, St. Mary's Hospital, Imperial College London, UK

Introduction: The risk factors for exposure or retraction after transvaginal mesh (TVM) surgery for pelvic organ prolapse (POP) are not well understood. Exposed or unexposed mesh may harbor bacteria, but the role of the host microbiome in the aetiology of exposure or retraction in unclear. Analysis of 16S rRNA gene sequences now permit high-resolution, species-level classification of all vaginal bacteria, and has broadened our understanding of the vaginal ecosystem.

Objective: To identify differences in the vaginal microbiome of women after TVM surgery with and without mesh associated complications.

Methods: Patients with complications after placement of a monofilament macroporous polypropylene mesh for primary prolapse repair were eligible as cases, patients without complications were eligible as controls. During vaginal examination, we obtained mid-upper vaginal specimens. 16S rRNA sequencing DNA was isolated, size selected pools were run on a Fragment Analyzer (Advanced Analytical, Ankeny, Iowa) to assess the size distribution, quantified using the Qubit 2.0 fluorometer (Life Technologies), and loaded on an Illumina MiSeq (Illumina, Inc. San Diego, California) for sequencing variable regions 1-2 (V1- V2) at RTLGenomics (Lubbock, TX). A rarefaction curve plot showed the number of sequences versus the number of species. Overall richness was expressed as the number of operational taxonomic units (OTUs) and was quantified using the Chao1 richness estimator. Overall diversity was expressed as Shannon Diversity. The latter were screened for group differences using an analysis of variance (ANOVA), multivariate differences were evaluated with ADONIS and distances were calculated using UniFrac.

Results: We recruited 14 patients after mesh exposure, 5 after mesh retraction and 21 as controls. No patient had exposed mesh at the time of samplingAll groups had similar demographics. The average number of OTUs per sample was 74.79, SD ± 63.91 for controls, 57.13 SD ±58.74 for exposure cases and 92.42, SD ±50.01 for retraction cases. 89.6% of the bacteria in the control group, 86.4% in the exposure group and 81.3% in the retraction group were classified as either Firmicutes, Proteobacteria or Actinobacteria. The most abundantly detected genus in all groups was Lactobacillus spp. Veillonella spp. was more abundant in patients after mesh retraction (p=0.045). The composition of each individual vaginal microbiome varied greatly and we did not detect any significant differences richness between groups, but with a trend towards higher diversity among women with mesh complications (Figure 2). The ADONIS and the PCoA did not however, detect significant multivariate differences among groups.

Conclusion: After mesh implantation, the vagina harbours a polymicrobial composition with substantial individual variability in diversity and richness. The presence of Veillonella spp. could represent a causal factor for mesh retraction, and could be specifically tested in prospective studies. Our study was not able to identify vaginal microbiotic dysbiosis as a factor associated with exposure. Larger cohort studies would be needed to distinguish the vaginal microbiome profiles of women predisposed to mesh-related complications. With meta-genomic phenotyping it may be possible to identify low-risk patients who could benefit from mesh augmented POP surgery, or provide targeted antibiotic cover at the time of mesh insertion

figureq

Figure 1: Relative abundance of the top 30 species in all samples, faceted by group

figurer

Figure 2: Diversity of cultivable bacteria

In cases and controls by Inverse Simpson

Index – samples classified in ascending order of values

References

  • Complications requiring reoperation following vaginal mesh kit procedures for prolapse. American journal of obstetrics and gynecology. 2008;199(6):678 e1-4.

  • Relationship between vaginal microbial dysbiosis, inflammation, and pregnancy outcomes in cervical cerclage. Sci Transl Med. 2016;8(350):350ra102.

  • The changing landscape of the vaginal microbiome. Clin Lab Med. 2014;34(4):747-61.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Boston Scientific, Coloplast).

030

Perioperative cardiovascular complications following urogynaecological operations

Larsen, MD 1 ; Guldberg, R 2 ; Lose, G 3

1: Center for Clinical Epidemiology, Odense University Hospital, and Research Unit of Clinical Epidemiology, Institute of Clinical Research, University of Southern Denmark; 2: Dept. of Obstetrics and Gynaecology, Aarhus University Hospital, Aarhus, Denmark; 3: Gynaecology and obstetrics department, Herlev Hospital &amp;amp; University of Copenhagen, Denmark

Introduction: The risk of perioperative cardiovascular complications following urinary incontinence (UI) and pelvic organ prolapse (POP) operations must be taken into consideration when planning urogynaecological operations. The literature on the cardiovascular risk following UI and POP operations shows diverging results.

Objective: To facilitate the clinicians’ decision making on complications following urogynaecological procedures, we aimed to estimate the mortality and the risk of cardiovascular complications following UI and POP operations.

Methods: This nationwide register-based study includes 13,992 UI and 35,765 POP operations during a period of ten years from 1 July 2007 through 30 June 2017 in 44,580 patients, collected from the Danish National Patient Registry and supplemented with clinical data from the Danish Urogynaecological Database. Women undergoing UI and POP operations will in general be in a condition where an operation is not contraindicated for any reason and therefore these women will be in a better health condition than the control group in the general population when matching a control group by age and comorbidity. We therefore used a study design similar to the case crossover design to analyse for a temporary increased risk of cardiovascular events 30 days following operation. We used a 31-180 days observation period as baseline, assuming the risk of cardiovascular events to uniformly distribute a following operation. The increased risk was estimated as an incidence rate ratio for women with and without cardiovascular comorbidity and adjustments were made for the relevant confounders’ age, BMI, smoking, use of alcohol, parity, ASA-score and the extent of procedure.

Results: Eleven patients died within 30 days following an operation of a total of 49 757 UI and POP operations. Overall, we found 84 cardiovascular events in the period 0-30 days after operation and 326 in the 31-180 day period (Figure 1). Of the women with a cardiovascular comorbidity 0.59% had cardiovascular complications following an operation, corresponding to the incidence rate ratios at 3.64 (95% CI: 2.67-4.97) compared with the baseline risk for this group (Table 1).

Conclusion: The risk of cardiovascular complications in urogynaecological operations is generally low, despite the fact that we found a lower rate of cardiovascular complications than in other register studies. A more conservative approach in treating UI and POP in Denmark and a higher part of vaginal procedures could be an explanation for a lower complication rate compared to other reported complication rates.

Table 1 Estimates of the incidence rate ratios of serious cardiovascular events the first month after urogynaecological operation according to time period according to baseline period (day 31-180)

  Low-risk patients High-risk patients
  Crude [95% CI] Adjusted [95% CI] Crude [95% CI] Adjusted [95% CI]
0-6 days . [.-.] . [.-.] 3.64 [2.67-4.97] 3.86 [2.86-5.23]
7-14 days 1.02 [0.32-3.27] 1.02 [0.32-3.27] 0.68 [0.36-1.28] 0.68 [0.36-1.28]
15-30 days 0.51 [0.16-1.63] 0.51 [0.16-1.63] 0.75 [0.49-1.16] 0.64 [0.41-1.03]
31-180 days 1 1 1 1
figures

Figure 1 Observed frequency (blue bars) of cardiovascular complications for the low-risk and the high-risk groups following urinary incontinence or pelvic organ prolapse operation and fitted frequency (red line)

Disclosure:

Work supported by industry: no.

031

Simple closure with conservation of the sling versus excision for tape extrusion; which provides the best outcome?

Karmakar, D 1 ; Dwyer, PP 1 ; Nikpoor, P 1 ; Schierlitz, L 1

1:Mercy Hospital For Women

Introduction: Synthetic mid urethral sling(MUS) is the most commonly performed anti-incontinence surgery performed globally for SUI with vaginal tape extrusion in 1-3% of women. This is an important cause of morbidity and litigation despite the overall small risk. Simple closure with conservation of the sling is attractive as it maintains sling integrity and continence but does it provide best outcomes?

Objective: To compare vaginal closure with versus without sling excision in the management of vaginal tape extrusion.

Methods: Surgically managed cases of extrusions were reviewed in a tertiary urogynaecological centre in Australia. Demographic, preoperative, operative data was retrieved from a sling database.

Results: 2823 women with urodynamic SUI had a synthetic MUS (2310 retropubic / 513 transobturator and single incision slings) between 1999 and 2017, with mean follow-up 100 months. 33 women (1.17%) had tape extrusion; 22 post retropubic and 11 post transobturator MUS. 31 needed surgical management (1.09 %); revisions for pain or voiding difficulty were excluded. Older age, BMI, DM, current smoking, trainee operator, recurrent vaginal/incontinence surgery , RP approach in ISD were independent risk factors for mesh extrusion on multivariate logistic regression analysis. 15 of 20 extrusions following retropubic MUS needing revision (2 additional midline extrusions managed conservatively) were midline and 5 lateral. 3 of the 11 extrusions cases following transobturator approach were midline and 8 lateral. The sling revisions were classified as simple closure with conservation of sling versus excision and repair. Demographic, urodynamic, procedural variables were similar at baseline between the 2 groups .

Outcome: 19 of the 20 had successful closure following sling excision. One required a further procedure to deal with lateral extrusion detected 6 months later.7 out of 11 who had vaginal closure alone with sling conservation needed a second procedure for recurrent extrusion. The vaginal portion of sling was removed and no SUI procedure performed. 2 of the 7 required further SUI surgery with 2 reporting persistent pain.

Continence: Of the 20 who had sling excision; 5 had concomitant SUI procedure. Five of the 15 who had sling excision alone needed further SUI surgery .Of the 11 women who had sling conservation, 7 required reoperation for recurrent extrusion. Recurrent SUI did not occur in any of the 4 who had successful closure. Of the 22 who had partial /complete excision of sling eventually & did not have a concomitant SUI procedure at time of revision ,7 had further continence procedure (31.82%).Overall out of 31 in the series ,7 needed further continence procedure (22.58%) .Failure i.e. non -resolution of extrusion and /or needing a second revision for extrusion is significantly higher with simple closure (P = 0.0048). Hospital stay was lower with simple closure by a day on average.

Conclusion: Vaginal Sling excision and repair has significantly better outcomes compared to vaginal closure with tape conservation. One in 3 women following partial/complete sling removal will redevelop SUI and require further surgery. Placement of another synthetic MUS at time of sling removal will reduce incidence of further SUI but risks serious infection.

Disclosure:

Work supported by industry: no.

032

High uterosacral suspension versus sacrospinous fixation in post-hysterectomy vault prolapse: Why take the additional risk?

Daly, JO 1 ; Vasudeva, N 1 ; Brown, B 2 ; Frazer, M 2

1: Western Health; 2: Gold Coast University Hospital

Objective: To demonstrate the potential risks of post-hysterectomy high uterosacral intra-peritoneal vault suspension and report the outcomes of HUSLS versus SSF, for apical vaginal prolapse at two subspecialty Urogynaecology units.

Methods: This is a surgical video demonstration and retrospective review of women undergoing HUSLS or a SSF for apical vaginal suspension with or without concomitant procedures at two subspeciality urogynaecology units – between January 2014 to July 2017 one unit and July 2012 to December 2015 in the other. The video demonstrates the approach to intraperitoneal high uterosacral suspension and the associated risks. The review reports perioperative complications in addition to patient satisfaction, anatomical outcomes and recurrence determined by the patient impression of prolapse improvement (PGI-I) and Pelvic Organ Prolapse Quantification (POP-Q) system, respectively. Ethics approval was obtained from local review panels.

Results: Two-hundred and seven patients met the inclusion criteria, with 122 HULS and 85 SSF being performed. The SSF patients were significantly older and had a higher BMI. A significantly higher number of HUSLS patients underwent a concomitant hysterectomy. Intraoperative recognition of ureteric obstruction occurred more frequently in the HUSLS group however this resolved universally with removal of one of the vault sutures. Of the bowel injuries, one occurred during the posterior repair, another was a minor serosal tear and the third occurred with a concomitant bladder injury during entry into the peritoneal cavity in a post-hysterectomy HUSLS, requiring a stoma. There was a significant improvement in POPQ outcomes however no difference between approaches. A higher PGI-I was observed in the SSF group. Recurrence rates were similar between the groups. (Table 1)

Table 1 - Outcomes HULS (n=121) SSF (n=82)  
Complications n % n % p
Ureteric obstruction – Intraoperative 5 4.13 0 0.00 0.06
Bladder injury 2 1.65 0 0.00 0.24
Bowel injury 2 1.65 1 1.20 0.79
Vault Infection 0 0.00 2 2.44 0.09
Postoperative bleeding 1 0.83 0 0.00 0.4
POPQ cm SD cm SD p
Ba - Pre 1.79 2.27 1.29 2.35 0.33
Ba - Post -2.07 1.51 -1.82 1.64 0.42
C - Pre 1.48 3.76 0.74 3.64 0.30
C - Post -7.78 2.24 -7.58 3.56 0.73
Bp - Pre -0.52 1.78 0.1 2.39 0.13
Bp - Post -2.41 1.12 -2.51 0.76 0.50
Prolapse outcomes n=74   n=45   
PGI-I POP n % n % P
Very Much Better/Much Better 65 87.84 43 95.56 0.01
Worse 1 1.35 0 0.00 0.44
Recurrence n % n % p
Total anatomical recurrence at 6 weeks 3 4.05 3 6.67 0.52

Conclusion: While both procedures appear to have similar short term anatomical success, the patient’s impression of prolapse improvement was higher in the SSF group. Additionally, there appear to be significant additional risks associated with the HUSLS at the time of post-hysterectomy vault suspension and consequently it may be most appropriate at the time of vaginal hysterectomy. The specific risks and benefits of each procedure should be carefully considered when discussing these options with patients.

Disclosure:

Work supported by industry: no.

033

Removal of urinary catheter around midnight following vaginal prolapse surgery

Hendriks, N 1 ; van Bavel, J 1 ; Veen, J 2 ; Speksnijder, L 1

1: Obstetrics and Gynaecology, Amphia Hospital, Breda, Netherlands; 2: Obstetrics and Gynaecology, Máxima Medisch Centrum, Veldhoven, Netherlands

Introduction: Post void residual (PVR) is one of the most common unwanted side effects after vaginal pelvic organ prolapse (POP) surgery, with a reported prevalence of 2.5 to 24 percent.1 Previous studies have shown safety and cost-effectiveness of indwelling catheter removal the day following surgery.2 Little data exists on short-term catheter removal following POP surgery.3 Removal of indwelling catheter around midnight might reduce anxiety for micturition and therefore reduce PVR.

Objective: To assess the safety and effectiveness on micturition of removal of indwelling catheter around midnight compared to removal the day following vaginal POP surgery.

Methods: All women undergoing vaginal POP surgery in two Dutch hospitals between January and December 2016 were included. Exclusion criteria were women undergoing concomitant stress urinary incontinence surgery and women undergoing laparoscopic POP surgery. At the first hospital (A), the indwelling catheter and vaginal pack are removed around midnight on the day of surgery, in hospital B, the indwelling catheter and vaginal pack are removed the morning following surgery. Spontaneous micturition is awaited. After micturition, PVR is measured using three-dimensional bladder ultrasonography. If PVR exceeds 150 milliliters, or if the patient is unable to void at all, clean intermittent catheterization (CIC) is advised. Women are discharged when they are able to perform CIC.

Results: A total of 252 women were included, 137 women in hospital A and 115 women in hospital B. The baseline clinical characteristics of all women are presented in Table 1.Women in hospital B underwent significantly more perineorrhaphy procedures and received more spinal anesthesia than women in hospital A. Seven women (5.1%) in hospital A and 29 women (25.2%) in hospital B were discharged with CIC (p<0.001). In univariate analysis we found a significant association between CIC and perineorrhaphy, total blood loss, spinal anesthesia and anterior vaginal wall POP surgery. After multivariate analysis only anterior wall vaginal POP surgery remains significantly associated with CIC (p < 0.05). Duration of hospital stay is comparable in both hospitals. No more urinary tract infections (UTI) occurred, although this was only tested in women with complaints of micturition.

Conclusions: Following vaginal prolapse surgery, the majority of women do not require CIC. Early removal of indwelling catheter reduces the number of women needing CIC in this cohort study. This might be explained by a lower level of anxiety for micturition because it follows a more natural micturition pattern. Although this regime has no effect on hospital stay, it might result in improved patient satisfaction, reduced hospital costs and less UTI.

figuret

References:

  1. 1.

    E.J. Geller, Prevention and management of postoperative urinary retention after urogynecologic surgery, International Journal of Women’s Health, august 2014

  2. 2.

    Phipps S, Lim YN, McClinton S, Barry C, Rane A, Dow JN. Short term urinary catheter policies following urogenital surgery in adults. Cochrane Database Syst Rev 2008; (3)

  3. 3.

    Glavind K, Mørup L, Madsen H, Glavind J.A prospective, randomised, controlled trial comparing 3 hour and 24 hour postoperative removal of bladder catheter and vaginal pack following vaginal prolapse surgery, Acta Obstet Gynecol Scand. 2007;86(9):1122-5

Disclosure:

Work supported by industry: no.

034

French observatory of pelvic floor repair surgery (with or without mesh), VIGI-MESH, first results after more than 1000 inclusions

Fritel, X 1 ; Campagne-Loiseau, S 2 ; de Tayrac, R 3 ; Ferry, P 4 ; Saussine, C 5 ; Garbin, O 5 ; Deffieux, X 6 ; Lucot, J 7 ; Salet-Lizee, D 8 ; Bartolo, S 9 ; Boisrame, T 5 ; Charles, T 1 ; Carlier-Guérin, C 10 ; Cosson, M 9 ; Fauconnier, A 11

1: CHU de Poitiers; 2: CHU Estaing; 3: CHU de Nîmes; 4: CH de La Rochelle; 5: CHRU de Strasbourg; 6: APHP CHU de Clamart; 7: CH de Béthune; 8: GH Diaconesses-Croix-Saint-Simon; 9: CHRU de Lille; 10: CH de Chatelrault; 11: CHI Poissy-Saint-Germain

Introduction: VIGI-MESH observatory was opened to collect surgical procedures for pelvic floor reconstructive surgery.

Objective: Our goal was to report prospectively serious complications.

Methods: Participation was offered to any woman operated for stress urinary incontinence, pelvic organ prolapse, or rectal prolapse. We included mid-urethra sling (MUS) or colposuspension, vaginal repair surgery with or without mesh, abdominal or laparoscopic repair surgery, and endoanal surgery. Artificial sphincters, balloons and periurethral injections were excluded. Women included were informed and gave their consent.

At the same time, severe complications were collected, distinguishing the complications that occurred in women included for their initial surgery in VIGI-MESH observatory and women previously operated or in other centres. The complications were classified according to Clavien-Dindo and ICS-IUGA classification. Only serious complications (Grade III and above) have been considered. Failure or recurrence of incontinence or prolapse were not considered as a severe complication.

Results: Since February 2017, 1080 women (mean age 63) were included (Table 1).

Table 1. First surgeries included in the VIGI-MESH observatory and incidence of serious complications.

Type of surgery Included, N Serious complications, n (%)
Mid urethra sling (MUS) alone 388 16 (4.1)
MUS and other procedure 94 4 (4.3)
Vaginal repair with mesh 205 2 (1.0)
Laparoscopic sacrocolpopexy 270 4 (1.5)
Vaginal repair without mesh 79 2 (2.5)
Other prolapse surgery 44 1 (2.3)
Overall 1080 29 (2.7)

During the same period, 107 women experimented serious complications, including 29 included at the time of their initial surgery in the VIGI-MESH observatory (incidence 2.7%, Table 1). The median time of onset of the complication was 44 months after the initial procedure (0 to 207), half of complications were reported more than 12 months after the initial procedure (Table 2).

Table 2. Time of serious complications (N = 107)

Type of surgery T1: perioperative-<48h T2: 48h-M2 T3: M2-M12 T4: > M12 Overall
Mid Urethra Sling (MUS) alone 4 6 22 26 61
MUS and other procedure 1 2 1 8 12
Vaginal repair with mesh 2 2 2 14 20
Laparoscopic sacrocolpopexy   3 2 4 9
Vaginal repair without mesh 2 0 1 1 4
Other prolapse surgery   1    1
Overall 9 14 28 53 107

Most were Grade IIIb complications (surgical revision under general anaesthesia), no resuscitation or death occurred. The most frequent complication (43%) was mesh or permanent suture exposures (Table 3). About two third of the complications (68%) were related to MUS procedures (Table 2).

Table 3. Types of complications (N = 107)

Serious complications needing surgical revision N
Mesh or suture exposure (vagina, urethra or bladder) 46
Obstructive micturition without exposure 19
Pain without exposure nor obstruction 22
Ureteric complication 3
Bleeding or hematoma 3
Perioperative injury 5
Other 10

Conclusion: First year after surgery, we observed an incidence of serious complications of 2.7%. In the other hand, when a mesh was used, half of surgical revisions for severe complication occurred more than one year after the initial surgery. It seems essential to continue a long-term vigilance after surgery of the pelvic floor when a mesh is used.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Boston Scientific, Aspide Medical, Coloplast, Allergan, AMS, Cousin Biotech, Bard, Astellas, B Braun).

035

Temporal trends in pelvic organ prolapse surgery with mesh and associated postoperative complications by surgical approach in Canada 2004-2014

Lisonkova, S 1 ; Geoffrion, R 1 ; Sanae, M 1 ; Brennand, E 2 ; Muraca, G 3 ; Larouche , M 4 ; Cundiff, G 1

1: University of British Columbia, Vancouver, Canada; 2: University of Alberta, Alberta, Canada; 3: University of British Columbia, Vancouver, Canada ; 4: McGill University, Montreal, Canada

Introduction: the rates of pelvic organ prolapse (POP) surgery involving mesh increased in Canada from 15.8 in 2004 to 21.0 per 100,000 women in 2007, then declined sharply to 12.6 per 100,000 in 2014 following reports of mesh-related complications. Temporal trends in various types of mesh POP procedures, including those using minimally invasive approaches, are unknown.

Objective: to examine temporal trends in various types of inpatient mesh POP surgery and immediate postoperative complications in Canada between 2004 and 2014.

Methods: we obtained information on all hospitalizations in Canada (excluding Quebec) from 2004 to 2014 from the Canadian Institutes for Health Information. Types of POP surgery involving mesh were identified using Canadian Classification for Health Interventions as follows: 1) vault reconstruction or suspension and fixation of vagina; 2) repair of cystocele and/or rectocele. Reconstruction/suspension/fixation of vagina was further examined by the type of surgical approach: vaginal and abdominal (open and laparoscopic). Postoperative complications included unexpected return to operating room, blood transfusion, anesthesia complications, mesh complications, and other (bleeding, infection, etc.); complications were identified by ICD-10-CM diagnostic codes. Temporal trends were assessed by the Cochran-Armitage test for trend, logistic regression was used to obtain adjusted odds ratios (AOR) and 95% confidence intervals (CI) for 1-year change in postoperative complications, adjusted for patient’s age, hypertension, diabetes, and any concomitant procedure being performed (e.g., hysterectomy).

Results: Overall, 19,263 mesh POP surgery hospitalizations occurred between 2004 and 2014. The rate of vaginal approach vault suspensions increased from 1.9 in 2004 to 4.3 per 100,000 in 2008 and then declined to 2.0 per 100,000 in 2014; the rate of open abdominal approach suspension declined from 6.6 in 2004 to 3.2 per 100,000 women in 2014; laparoscopic approach increased from 1.0 to 3.0 per 100,000 women from 2004 to 2014. The rate of cystocele/rectocele repair with mesh increased from 7.4 in 2004 to 12.2 in 2007 and then declined to 5.5 per 100,000 women in 2014.

The rate of immediate postoperative complications was 6.8% and ranged between 5.8% and 8.0% (trend p=0.78). With respect to reconstruction/suspension/fixation surgery, the rate of complications was 5.4% with vaginal approach (trend p=0.87), 10.4% with open abdominal approach (trend p=0.90), and 5.9% with laparoscopic approach. The rate of complications in the laparoscopic suspension surgery increased from 2.2% in 2004 to 8.4% in 2014 (trend p<0.01; AOR=1.12, 95% CI: 1.04-1.20). Postoperative complication rate was 5.5% for cystocele/rectocele repairs (trend p=0.69).

The length of hospital stay in all mesh POP surgery declined from a median of 3 days (2004-2008) to 2 days (2009-2014), p<0.01 (inter-quartile ranges 2-4 and 1-3 days, respectively).

Conclusions: Temporal increase in mesh POP surgery from 2004 to 2007 and a subsequent decline was driven mainly by the rates of vaginal approach suspension surgery and cystocele/rectocele repairs. There was an overall decline in open abdominal surgery. Laparoscopic approach increased over time for mesh reconstruction and was associated with the greatest increase in complication rates. More research focused on POP reconstructive techniques using mesh is needed to optimise postoperative outcomes.

Disclosure:

Work supported by industry: no.

036

Efficacy of clorpactin in bladder pain syndrome/interstitial cystitis: a randomised controlled trial

Cvach, K 1 ; Dwyer, P 1 ; Rosamilia, A 2 ; Schierlitz, L 1 ; Lim, Y 1 ; De Souza, A 1 ; Thomas, E 1 ; Murray, C 1 ; Leitch, A 2 ; Ow, LL 1

1: Mercy Hospital for Women; 2: Monash Health

Introduction: Clorpactin (oxychlorosene sodium) is an antibacterial agent originally used in Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) patients when infection was thought to be an inciting event in the BPS/IC cascade. Limited evidence for its use as an intra-vesical agent currently exists and this is the only randomised trial to assess Clorpactin’s efficacy.

Objective: A multi-centre, single-blinded randomised controlled trial to investigate whether Clorpactin intra-vesical instillation results in symptom improvement in the BPS/IC patient population.

Methods: Women aged 18-80 diagnosed with BPS/IC were randomised to undergo cystoscopy/hydrodistension or instillation of Clorpactin 0.4% solution under general anaesthesia. Women were excluded if there was a history of renal impairment or vesico-ureteric reflux, or had a contraindication to the administration of Clorpactin or anaesthesia. Baseline demographic data were collected on history and examination. Primary outcome was based on Global Response Assessment (GRA) at 3 months. Secondary outcomes were based on O’Leary Sant Symptom (OLSI) and Problem (OLPI) questionnaire scores, visual analogue scale (VAS) score for pain and 24 hour bladder diary parameters. At 3 months cystoscopy/hydrodistension non-responders were offered active treatment with Clorpactin. Responders to Clorpactin who returned to their pre-treatment level of BPS/IC symptomatology were offered Clorpactin re-treatment.

Results: A total of 49 women were recruited – 25 randomised to cystoscopy/hydrodistension and 24 to clorpactin. There were no differences in baseline demographics between the 2 groups. 73% of women had previously tried medical management (oral or intra-vesical) and 70% were currently on oral medical management. Complete follow-up data was available on 11 in the cystoscopy group and 15 in the Clorpactin group. Post-treatment VAS pain scores did not differ between groups although 4 women in the Clorpactin group required admission for pain within 6 weeks of treatment compared to 1 in the cystoscopy group. Response rate at 3 months based on GRA was 9.1% for cystoscopy and 53% for Clorpactin (p=0.05). There was a significant reduction from baseline in mean total scores for OLSI (14.2 to 9.2; p=0.007) and OLPI (12.6 to 7.7; p=0.001) at 3 months in the Clorpactin group but this was not seen in the cystoscopy group. VAS pain scores at 3 months were significantly reduced in the Clorpactin group (7.4 to 3.3; p<0.001) but not in the cystoscopy group. There were no significant changes from baseline in bladder diary parameters at 3 months in either group. Women with pre-treatment cystoscopic bladder capacity <500ml had less improvement in OLPI total scores at 3 months in both groups but this did not reach statistical significance (p=0.053) 17 non-responders in the cystoscopy group elected to undergo Clorpactin treatment after 3 months and 7 women elected to have repeat Clorpactin treatment.

Conclusions: Clorpactin treatment results in significant reduction in BPS/IC symptoms, bother and pain based on the OLSI/OLPI and VAS pain scores at 3 months post-treatment compared to cystoscopy/hydrodistension. Whilst assessment of response based on GRA did not reach statistical significance this is likely due to the study being underpowered. These conclusions are limited by the high loss to follow-up in both groups.

Outcome Cystoscopy (N=11) Clorpactin (N=15) p value
GRA (very much/much better) 6 weeks
3 months
28.6%
9.1%
52.9%
53%
0.32
0.054
OLSI total Baseline 15.4 14.2  
6 weeks 13.3 10.5  
3 months 16.8 (p 0.22) 9.2 (p 0.007) 0.03
OLPI total Baseline 12.9 12.6  
6 weeks 11.3 9.4  
3 months 13.3 (p 0.25) 7.7 (p 0.001) 0.08
VAS Baseline 7 7.4  
6 weeks 5.6 3.0  
3 months 7 (p 1.00) 3.3 (p<0.001) 0.07

GRA: chi-square; OLSI/OLPI/VAS: mixed between-within subjects ANOVA

Disclosure:

Work supported by industry: no.

037

The urinary microbiota of women with recurrent urinary tract infections: Opportunities to improve clinical care

Jung, C 1 ; Hochstedler, B 2 ; Price, T 2 ; Wolfe, A 2 ; Brubaker, L 1

1: University of California, San Diego; 2: Loyola University Chicago

Introduction: Urinary tract infection (UTI) afflicts up to 50% of women in their lifetime and is a common indication for antibiotics. A subgroup of patients experiences recurrent UTIs (R-UTI), which leads to not only short-term antibiotic treatment, but also long-term chronic suppressive antibiotic therapy. This extensive antibiotic use has both patient and public costs in the form of adverse drug events and increasing community antibiotic resistance. However, there is still a major gap in our understanding of R-UTI pathophysiology. Long considered a sterile environment, the urinary bladder is now known to host live bacteria that make up the female urinary microbiota (FUM), which likely contributes to both bladder health and disease. The FUM of R-UTI patients is not well-described and could provide valuable insights into this difficult-to-treat disease process.

Objective: To describe the urinary microbiome of women with R-UTI.

Methods: This is a descriptive analysis of an ongoing IRB-approved prospective observational study of women with R-UTI. We included subjects ≥18 years old with ≥3 medically diagnosed symptomatic UTIs within the preceding year. We excluded those with known anatomic abnormalities of the urogenital tract, those with neurologic or immunologic disease, a history of bladder malignancy, or those with current systemic infection. We collected both a voided and a catheterized urine specimen from each subject. The urine specimens were submitted for culture via standard urine culture (SUC) as well as via expanded quantitative urinary culture (EQUC). Demographic variables were also collected.

figureu

Results: Paired catheterized and voided urine samples from 23 women were analyzed. The average age was 69 years old and the majority was Caucasian (87%), postmenopausal (87%), currently using vaginal estrogen (61%), and had taken antibiotics for a UTI within the last 30 days (73%). The average number of lifetime, self-reported UTIs was 30 with an average R-UTI duration of nine years. In these subjects, eight (35%) catheterized specimens and one (4%) voided specimen were culture-negative on both EQUC and SUC. Of culture-positive specimens, EQUC detected a larger total number of uropathogens compared to SUC on both catheterized (17 vs. 10) and voided (37 vs. 13) specimens (Figure). From voided specimens, we cultured a larger total number of uropathogens than catheterized with both EQUC (37 vs. 17) and SUC (13 vs. 10), and identified bacteria not seen in the catheterized specimens. With both EQUC and SUC, nine (39%) of the subjects’ catheterized cultures were dominated by typical uropathogens (Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterococcus faecalis, Enterobacter aerogenes, Proteus mirabilis), but almost half (44%) of those did not have UTI symptoms. Indeed, none of the three (13%) E. coli-dominant subjects were symptomatic. EQUC detected E. faecalis more frequently than SUC for both catheterized (5 vs. 1) and voided (9 vs. 2) urine.

Conclusions: In paired catheterized and voided urine samples from women with R-UTI, EQUC was more sensitive than SUC, displaying more frequent and diverse uropathogen detection, and should therefore be considered in this patient population. Despite colonization by uropathogens, many women were asymptomatic, including the minority that was E. coli-dominant.

Disclosure:

Work supported by industry: no.

038

Study of the pathophysiological signals in the urine of female patients with recalcitrant LUTS presenting with acute flare while on long term antibiotic treatment

Swamy, S 1 ; Yan, A 1 ; Dharmasena, D 1 ; Collins, L 2 ; Sathiananthamoorthy, S 2 ; Malone-Lee, EPJ 2

1: University College London; 2: UCL

Ethics: This study had ethical committee approval from NRES Committee South East Coast – Surrey, Ref-11/LO/0109

Introduction: Chronic urinary tract infections (UTIs) are implicated in the aetiology of chronic Lower Urinary Tract Symptoms (LUTS). Conventional screening tools such as the dipstick and routine MSU culture are unreliable in detecting chronic UTIs and have been discredited (1,2). Intracellular bacterial colonisation had been demonstrated in patients suffering from chronic UTIs (3). Consequently many patients presenting with chronic UTIs are often not treated because they are not diagnosed with UTIs.

Aim: The aim of this study was to investigate the signals in the urine of female patients with chronic LUTS who present with an acute flare while on long-term oral antibiotic treatment

Methods: 21 patients and 21 asymptomatic female controls were recruited. Mean age of patients was 62 years (95% CI 52-71 years) and 41 years (95% CI 34-49 years) for controls. The symptoms were assessed using validated questionnaires. 37 MSU and 4 stoma/catheter specimens were collected. Urinary dipstick, routine MSU culture, fresh urine microscopy, benchtop ATP, spun sediment culture and epifluroscent cytology were carried out. In addition patients were examined for presence of suprapubic and loin tenderness and a sample of blood was taken to measure systemic markers of infection.

Results: There was a significant difference in the symptoms scores, microscopic pyuria, uroepithelial cell count, ATP, and spun sediment cultures between patients and controls with uropathogens dominating in patients. Routine diagnostic tests, suprapubic tenderness, CRP, ESR and WCC did not distinguish patients from controls.

Conclusion: There was a qualitative difference in the microbiome of patients with LUTS compared to controls, when they experience an acute flare, despite being on antibiotic treatment for chronic UTI. Normal CRP, ESR and WCC in a symptomatic patient does not rule out infection. Microscopic pyuria is the most reliable marker for infection.

figurev

References

1. Deville, W.L., et al., The urine dipstick test useful to rule out infections. A meta-analysis of the accuracy. BMC.Urol., 2004. 4: p. 4.

2. Hooton, T.M. and W.E. Stamm, Diagnosis and treatment of uncomplicated urinary tract infection. Infect.Dis.Clin.North Am., 1997. 11(3): p. 551-581.

3. Horsley H, Malone-Lee J, Holland D, et al. Enterococcus faecalis Subverts and Invades the Host Urothelium in Patients with Chronic Urinary Tract Infection. Ed. Willem van Schaik. PLoS ONE 8.12 (2013): e83637.

Disclosure:

Work supported by industry: no.

039

The imposition of a hospital antimicrobial guideline on patients with chronic, recalcitrant UTI and LUTS - The consequences for the patients – A cautionary tale

Swamy, S 1 ; Dharmasena, D 1 ; Dehpour, T 2 ; Toteva, H 2 ; Collins, L 3 ; Sathiananthamoorthy, S 3 ; Malone-Lee, EPJ 3

1: University College London; 2: Whittington Hospital; 3: UCL

Ethics: Ethical committee approval not needed for this outcome study titled: An analysis of outcomes and adverse events associated with the treatment of recalcitrant lower urinary tract infection. Protocol, Email from senior research nurse and Research Governance Manager and R&D Approval document attached

Introduction: Patients who present with recalcitrant LUTS, and have failed managements in other centres, have been treated successfully with long term oral antibiotic therapy for over two decades. The observational data have been presented at national and International conferences. A tertiary level LUTS service dealing with Chronic UTIs and Chronic recalcitrant LUTS was suspended between 21st October and 23rd November. The crisis was caused by imposition of treatment guidelines, appropriate to acute UTI, on these patients, by the hospital pharmacy committee. For many patients, this meant sudden cessation of treatment.

Aim: To study the effects of unplanned antibiotic withdrawal for patients on long term antibiotic therapy for recalcitrant chronic urinary infection

Methods: Following reinstatement of the LUTS service, patients were invited back for a review. Patient’s symptoms and urinalysis by microscopy of fresh unspun specimens using a haemocytometer to count white cells and urothelial cells

Results: 176 of patients had ceased treatment; 160 deteriorated (90%) in the aftermath. Complete data set was available for 156 patients. 11 patients were admitted to hospital for IV therapy. Paired sample t test showed significant increases in the total symptom score, urgency, pain, stress incontinence, pyuria count, urothelial cell shedding.

Conclusion: These events, regrettable though they are, provide evidence of the fact that the treatment policies were based on thought, sense and science. These chronic infections are not imagined, even though they confound the conventional tests for urine infection. The use of the protracted antibiotic regimes, whilst associated with their own risks, is needed until we can come up with better options. Procrustean approaches to medical care that force outliers into guidelines designed for other conditions (acute UTI) are not going to succeed.

References:

1. Treating OAB with antibiotics http://www.ics.org/Abstracts/Publish/106/000112.pdf

2. Lengthy antibiotic treatment to resolve recalcitrant OAB http://www.ics.org/Abstracts/Publish/180/000619.pdf

3. Antibiotics May Improve Treatment of Overactive Bladder http://www.renalandurologynews.com/international-continence-society/antibiotics-may-improve-treatment-of-overactive-bladder/article/210740/

figurew

Disclosure:

Work supported by industry: no.

040

Diamine oxidase and mast cell count; Two separate roles in the pathogenesis of bladder pain syndrome

Ford, A 1 ; Asfour, V 1 ; Tailor, V 1 ; Gibbs, K 2 ; Fernando, R 1 ; Digesu, A 1 ; Khullar, V 1

1: St Marys Hospital; 2: Imperial College

Introduction: Bladder pain syndrome (BPS) is estimated to affect between 3.3 and 7.9 million women in the United States and is becoming an increasing health burden worldwide. Historically BPS could be triggered by infection, but there is an association with increased production of mast cells in the bladder wall. Histamine itself causes smooth muscle contraction and alters pain perception contributing to the pain component of BPS. Histamine is metabolised within the body by the enzyme diamine oxidase (DAO). If the serum DAO is less than 10, those individuals have difficulty in metabolising histamine and this can lead to increased levels in the tissue. This is diagnosed as histamine intolerance. Therefore there are two potential causes for increased histamine in the bladder which could lead to BPS.

Objectives: We hypothesise that low DAO and increased mast cells may play separate roles in the pathophysiology of BPS. We aim to ascertain this through serum DAO measurement and mast cell (MC) count on bladder biopsy in patients with BPS.

Methods: We carried out a retrospective observational study in a tertiary unit between 2015 and 2017 including women presenting with BPS. Serum DAO activity was performed in all patients and a level below 10 IU/ml was considered diagnostic of histamine intolerance. A mast cell count was performed on bladder biopsies taken at cystoscopy and considered raised if the number of mast cells was > 25 per square millimeter using CD117 immunohistochemistry.

Results: In total 139 women with BPS were recruited. Each had a DAO blood level and MC count performed. 38/139 women had a DAO level of <10, 75/139 had level of 10-30 IU/ml and 26/139 had a level above 30 IU/ml. 93/140 women had high a MC count of >25per mm2 on bladder biopsy. Of the women with DAO <10 IU/ml, 21/38 (55%) had raised MC counts, of the women with a DAO of 10-30 IU/ml 54/75 (72%) had a raised MC count and of the women with a DAO of > 30 IU/ml 18/26 (70%) had raised MC counts. When analyzing women with histamine intolerance (DAO <10 IU/ml) 21/38 (55%) of those had raised MC count on biopsy as opposed to 71/101 (70%) where histamine intolerance is unlikely. A Pearson’s Chi squared test was performed but was found not to be significant (2.789, p=0.095.

Conclusion: There is a higher proportion of increased mast cells on bladder biopsy in women with a DAO of >10 IU/ml than women with a DAO of <10 IU/ml, although this was not found to be statistically significant. This trend raises the possibility of supporting the hypothesis that there are two groups of patients with different pathologies for BPS. The first group has histamine intolerance caused by an enzyme abnormality (low DAO of <10 IU/ml) prohibiting the breakdown of histamine and the second have increased mast cells at tissue level demonstrated on biopsy. Both of these lead to increased circulating histamine and symptoms of BPS but treatment could differ with mast cell stabilization being important in women with increased mast cells on biopsy.

Disclosure:

Work supported by industry: no.

041

Lactobacillus species associated with overactive bladder

Duckett, J 1 ; Wildman, S 2 ; Curtiss, N 1

1: Medway Hospital; 2: University of Kent

Introduction: The presence of Lactobacillus in urine appears to be associated with a healthy bladder, however, the genus of lactobacillus is very diverse with over 224 species and different lactobacillus subtypes display different properties. By Identifying and comparing the subtypes of lactobacillus species present in the urine of controls vs. patients with Overactive Bladder (OAB) symptoms we may gain insight to how some lactobacilli may be helpful in maintaining bladder health. There are known difficulties with identification of lactobacilli by phenotypical methods. Indeed before the use of molecular techniques, l.crispatus, l.jensenii and l.gasseri had not been differentiated as distinct species. MALDI-TOF log scales were only sufficient to indicate correct genus identification. Therefore, we instead identified lactobacilli using 16SrRNA using two areas of the 16SrRNA gene encompassing different variable regions.

Objective: To test the hyptothesis that different Lactobacilli species are present in the urine of women with OAB and healthy controls with no bladder symptoms.

Methods: Lactobacilli from the urine of 19 Women with OAB and 34 healthy women scoring 0 on ICIQ short form were investigated. The Lactobacilli were identified from a database of stored samples of cloned bacteria grown from single colonies from urine samples. These had previously been identified as lactobacillus, when investigated to the genus level, were taken from the -80oC freezer. 5 microlitres were plated using aseptic technique onto chocolate agar plates and grown in aerobic conditions with added CO2 for 48hours. Bacteria were then lysed in 100ul of water and Polmerase chain reaction used to amplify two different variable regions of the 16SrRNA using two primer pairs; Pair A (variable region 1) and Pair B (variable region 3-4);

Pair A:

FWD: TP16U1 5’AGAGTTTGATCMTGGCTCAG-3’

REV: RT16U6 5’-ATTGTAGCACGTGTGTNGCCC-3’

Pair B:

FWD: U341F - 5'-CCTACGGGRSGCAGCAG-3'

REV: Bakt 805R - 5'-GACTACHVGGGTATCTAATCC-3

The resultant sequences were compared to the public sequence database BLAST ( http://blast.ncbi.nlm.nih.gov/Blast.cgi ).

Results: In total of 53 different lactobacillus samples were analysed. 19 from women with OAB and 34 from healthy controls. Sequences were matched for both primer sets for each sample. There was strong concordance between the two primer sets only 2 had different species matched. In these cases, the species was decided by the best match species from the original work using the V9 variable region. 5 different species of Lactobacilli were identifed in this work: L.Jensenii, L gasseri, L.iners, L.salivarius and L.crispatus. 26% of all lactobacillus samples from women with OAB were l.salivarius whereas no control lactobacillus samples were l.salivarius (p=0.004)(see fig 1).No other significant differences were identified.

figurex

Conclusions: Lactobacillus salivarius was present in the urine of women with OAB but not identified in the urine of any healthy controls.

Disclosure:

Work supported by industry: no.

042

Linking pelvic floor muscle function terminology to the International Classification of Functioning, Disability and Health

Saltiel, F1; Miranda-Gazzola, APG1; Vitória, RO1; Monteiro , MVC1; Figueiredo , EM1

1: Universidade Federal de Minas Gerais

Introduction: Standardized terminology properly anchored in consistent theoretical framework is crucial to effective communication among health care professional and public of interest, to the advance in scientific knowledge and dissemination of evidence-based practice.

Objective: Aims were: a) to link the pelvic floor muscle function (PFMF) terminology identified in the literature to the International Classification of Functioning, Disability and Health (ICF) terminology; b) to identify which are the most investigated PFMF; c) to map which are the most used instruments to evaluate those functions; d) to propose a pelvic floor muscle function evaluation system.

Methods: This is a secondary analysis study from PFMF previously identified in literature in a systematic review (Saltiel et al., Terminology of pelvic floor muscle function of women with and without urinary incontinence: a systematic review of the literature. under review, 2018), which were linked to ICF terminology according to standardized linking rules. Three researchers performed the linking independently. Disagreements were solved by open dialogue with a fourth researcher.

Results: By using the ICF standardized linking rules we could reduce the 196 PFMF terms used in the specialized literature into six terms. The most investigated PFMF were, consecutively: Strength (25.6%), Involuntary movement reaction (21.9%), Endurance (17.2%), Control (14.1%), Coordination (9.9%) and Tone (4.2%). A wide variation of instruments used to measure PFMF was identified; vaginal palpation was the method employed to measure all six PFMF. A Pelvic Floor Sensory and Muscle Function Evaluation system emerged from results of this study and it is presented in Figure 1. It is based on the universal terminology of ICF/WHO and on the most frequently used and accessible instruments to measure PFMF described in literature.

figurey

Conclusions: Linking PFMF to ICF was feasible and valid. This may improve communication and foster the advance in scientific knowledge towards more precise assessment, diagnosis and therapeutic approaches for impairments of PFMF among women with pelvic floor dysfunctions.

Disclosure:

Work supported by industry: no.

043

To operate is to complicate! A prospective study of the complications of native tissue, mesh and biological grafts for anterior and posterior prolapse repairs

Freeman, R 1 ; Elders, A 2 ; Breeman, S 3 ; Hemming, C 4 ; Cooper, K 4 ; Smith, A 5 ; Hagen, S 2 ; McDonald, A 3 ; MacLennan, G 3 ; Norrie, J 6 ; Glazener, C 3 ; Reid, F 5

1: University Hospitals Plymouth NHS Trust; 2: Glasgow Caledonian University; 3: University of Aberdeen; 4: NHS Grampian; 5: Manchester University NHS Foundation Trust; 6: University of Edinburgh

Introduction: Any surgery can result in complications. Large datasets are needed to evaluate complications of surgery, however registries may under-report complication rates and do not provide the necessary context of a comparison with native tissue repairs.

Objective: To compare the characteristics of complications following native tissue, polypropylene mesh and biological graft surgery for anterior and/or posterior prolapse repair.

Methods: In a prospective study of treatment received, 2632 women, undergoing anterior and/or posterior prolapse surgery, in 35 centres in the UK, chose or were randomised to 1) native tissue repair, 2) polypropylene mesh inlay, 3) biological graft or 4) polypropylene mesh kit. Follow-up was performed using standardised questionnaires at 6, 12 and 24 months and complications were recorded using the IUGA/ICS classification system.

Results: Complications associated with prolapse surgery are low, however readmission to hospital over the first two year period was 4% for native tissue procedures, 10% for mesh inlays, 8% for biological grafts and 6% for mesh kits (Table 1). Pain was more common in the polypropylene mesh inlay group. In all groups, there was delayed onset of pain, not occurring in the first two months, and it was less common in women after 12 months. Surgical removal of mesh was required in 8% (31/390) of women with mesh inlay and 8% (5/65) of those with mesh kit within the first 2-years. De novo dyspareunia was uncommon, although many women were not sexually active. In those who were sexually active, the proportions at 2 years were: native tissue repair 2% (16/645), mesh inlay 1% (2/191), biological graft 3% (4/156) and mesh kit 4% (1/24).

Conclusions: This is the first large data series to use the IUGA/ICS classification system of complications for both native tissue and repairs with biological or polypropylene mesh. Excluding those associated with mesh, complications rates were similar between the groups.

  Native tissue repair Mesh
inlay
Biological graft Mesh
kit
N=1712 N = 481 N = 361 N = 78
Intraoperative/postoperative complications
Injury to organs 10 (0.6) 2 (0.4) 1 (0.3) 0 (0.0)
Excess blood loss 9 (0.5) 4 (0.8) 3 (0.8) 0 (0.0)
Return to theatre <72hrs 11 (0.6) 5 (1.0) 2 (0.6) 1 (1.3)
Catheter >10 days 70 (4.1) 14 (2.9) 12 (3.3) 7 (9.0)
Complications within 2 years
Urinary retention 53 (3.1) 12 (2.5) 9 (2.5) 4 (5.1)
Vaginal adhesions 25 (1.5) 6 (1.2) 12 (3.3) 1 (1.3)
Re admission to hospital 70 (4.1) 48 (10.0) 29 (8.0) 5 (6.4)
—related to mesh 2 (0.1) 34 (7.1) 1 (0.3) 3 (3.8)
—unrelated to mesh 68 (4.0) 14 (2.9) 28 (7.8) 2 (2.6)
Patient compromise 39 (2.3) 15 (3.1) 10 (2.8) 3 (3.8)
Any pain 60 (3.5) 31 (6.4) 14 (3.9) 3 (3.8)
—within 2 months 2 (0.1) 0 (0.0) 0 0.0) 0 (0.0)
—between 2 and 12 months 50 (2.9) 26 (5.4) 10 (2.8) 2 (2.6)
—between 12 and 24 months 8 (0.5) 7 (1.5) 4 (1.1) 1 (1.3)
Pain on vaginal examination 3 (0.2) 2 (0.4) 2 (0.6) 1 (1.3)
Pain during sexual intercourse 20 (1.2) 8 (1.7) 5 (1.4) 0 (0.0)
Pain during physical activities 3 (0.2) 1 (0.2) 0 0.0) 0 (0.0)
Spontaneous pain 34 (2.0) 22 (4.6) 7 (1.9) 2 (2.6)
Any infection 44 (2.6) 9 (1.9) 13 (3.6) 2 (2.6)
—no abscess 43 (2.5) 9 (1.9) 12 (3.3) 2 (2.6)
—abscess 1 (0.1) 0 (0.0) 1 (0.3) 0 (0.0)
Any mesh exposure 5 (0.3) 55 (11.4) 1 (0.3) 7 (9.0)
—mild < 1 cm 3 (0.2) 20 (4.2) 1 (0.3) 2 (2.6)
—severe > 1cm 2 (0.1) 35 (7.3) 0 (0.0) 5 (6.4)

Disclosure:

Work supported by industry: no.

044

The complex urinary bacterial community in patients with lower urinary tract symptoms

Sathiananthamoorthy, S1; Malone-Lee, J1; Khasriya, R2; Gill, K1; Swamy, S1; Collins, L3; Rohn, J1

1: UCL; 2: UCH; 3: Middlesex University London

Introductio: Lower urinary tract symptoms (LUTS) are a burden to human health worldwide. A key step in the investigation of LUTS is to rule out the possibility of urinary tract infection (UTI). This step is made challenging by the accumulating evidence highlighting the inadequacies of routine diagnostic tests, including the midstream urine (MSU) culture (1). Given the recognised limitations associated with culture-based bacterial characterisation studies, 16S rRNA gene sequencing offers a less biased approach. This approach has previously been used to characterise patients with UUI (2) and other urological conditions.

Objective: To characterise and compare the urinary tract bacterial communities of patients that described LUTS suspected to have a UTI with asymptomatic individuals using 16S rRNA gene sequencing.

Methods: This study was conducted with ethical approval from the East London & the City, UK. Clean-catch MSU specimens were provided by patients attending their first clinic appointment at the Whittington Hospital Clinic, UK. Asymptomatic controls were recruited from staff, students and the general population. A 2-5ml aliquot of urine was submitted to a hospital laboratory, requesting for a routine MSU culture. A 1 microlitre calibrated loop of urine was plated on chromogenic culture medium, which was then placed in an ordinary 37°C incubator. The cultures were identified and interpreted as “no significant growth”, “mixed growth of n types of organisms” and “≥ 105cfu/ml of one organism”. 16S rRNA gene sequencing was performed on 1ml unspun aliquots and 400μl urinary cell sediment that resulted from concentrating 30ml of urine.

Results: Urine specimens were analysed for 33 patients attending their first clinical appointment (mean age= 49 years, sd=16.5) and 29 controls (mean age=40.7 years, sd=15.7). Bacterial DNA was detected in the urine samples of 32 (97.0%) patients and 26 (89.7%) controls. Enterobacteriaceae were the most predominant taxa in first-visit patients, whereas Streptococcus most abundant in controls. The Kruskal-Wallis test identified significantly higher distribution of median number of observed taxa overall (spun and unspun samples combined) between new patients and controls (χ2 = 8.0, df = 2, P <0.05). Significant differences were not identified between patient and control unspun samples (χ2 = 4.6, df = 2, P = 0.09) or patient and control spun samples (χ2 = 3.8, df = 2, P = 0.14). These results suggest that combining the unspun urine and spun urine samples improves the resolution and clarifies the distinction between bacterial communities from LUTS patients and healthy individuals.

Conclusions: This study provided insight into the complexity of the urinary bacterial community in health and LUTS suggestive of UTI, and identified the core urinary microbiota shared by patient and controls. Combining unspun urine with spun-down urinary epithelial cell concentrates optimised the species richness for the patient cohort, resulting in a significant difference between patient and control bacterial communities. Using urinary sediment to inspect bacterial composition may provide much-needed clarity about the differences between symptomatic and healthy people, in turn informing diagnosis and treatment.

References

  1. 1.

    Journal of Clinical Microbiology. 2013 Jul;51(7): 2054-62.

  2. 2.

    mBio. 2014 August 29, 2014; 5(4).

Disclosure:

Work supported by industry: no, by n/a.

045

Are we getting better at diagnosing, treating, and managing obstetric anal sphincter injuries (OASI)?

Eisenberg, V 1 ; Solomon, L 1 ; Vernikovsky, G 1 ; Lantsberg, D 1 ; Bitman, G 1 ; Alcalay, M 1

1: Sheba Medical Center Tel Hashomer and Sackler Faculty of Medicine Tel Aviv

Introduction: The implementation of a hands-on workshop has been suggested to improve OASI diagnosis, classification, consequent repair and management.

Objective: To evaluate the effect of a hands-on training workshop for OASI repair, and 3D transperineal ultrasound (TPUS) follow-up on the diagnosis, management and outcome of women with OASIS.

Methods: In December 2011 a hands-on training workshop was conducted, after which women with OASI underwent repair in the operating theatre by a trained obstetrician gynecologist or colorectal surgeon. Subsequent follow-up included (before and after the workshop) an interview, pelvic examination, standardized pelvic floor, sexual function, and Cleveland Clinics Incontinence Score (CCIS) questionnaires and TPUS. Ultrasound datasets were analyzed offline at a later time blinded to clinical data. On TPUS with tomographic ultrasound imaging (TUI), a residual sphincter defect was defined as any defect in either the external (EAS) or internal anal sphincter (IAS) on at least four/six slices ≥ 1 hour of the 12 hour clock-face or an angle of ≥ 30º. Statistical analysis was performed using SPSS (P < 0.05). The groups before and after the structured management protocol were studied with regards to pelvic floor and anal incontinence symptoms and residual sonographic defects.

Results: There were 173 and 188 women with OASI before and after the workshop, respectively. Tear classification after the workshop was: 3A – 108 (57.4%), 3B – 32 (17%), 3C – 26 (13.8%), and 4th degree tears – 22 (11.7%). There were no differences between the groups in age, BMI, nulliparity rate (71%), gestational week, fetal weight, fetal head circumference or gender. After the implementation of structured management there was a trend towards a decrease in the use of instrumental deliveries, second stage duration, epidural anesthesia, and episiotomy use, but none of these reached statistical significance. Structured management improved adherence to follow up visits (p<0.001). Symptoms of stress incontinence, dyspareunia, and anal incontinence improved in the second group, but this reached significance only for the prevalence of CCIS≥4. On TPUS there was a trend towards a longer perineal body, wider transverse muscle width, less residual EAS and IAS defects that did not reach statistical significance. Overall there were significantly less residual defects in women after structured management (Table 1).

Conclusions: It seems that women had a trend to fare better after the implementation of a structured management workshop, in terms of symptoms and residual TPUS findings. We expected a greater improvement which we did not find over the follow up time. A longer follow up period with repeated visits is planned, and a repeat workshop was performed. This study highlights the importance of training and adequate follow up. Structured training and follow-up in a dedicated Urogynecology/perineal clinic by experienced staff, using a validated bowel symptom questionnaire and 3D TPUS, may improve patient outcome after OASI.

Table 1: Comparison between groups before and after structured hands-on training.

Parameter Before workshop After workshop P
  N=173 N=188  
Time from delivery to first follow-up (months) 10±16.4 5.2±6.3 <0.001
Time from delivery to second follow-up (months) 29.4±19.2 18.7±16.5 <0.001
Time between 2 follow-up visits (months) 21.9±16.7 14.2±14 0.001
CCIS≥4 on questionnaire (percentage) 31.7 22 0.043
Any residual defect on (percentage) 91.9 83.4 0.017

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Work supported by industry: no.

046

Defecatory dysfunction as a predictor of pessary failure

Geller, E 1 ; Dengler, E 1 ; Mounsey, L 1 ; Gines, F 1 ; Agha, M 1 ; Long, T 1

1: University of North Carolina at Chapel Hill

Introduction: The pessary is a common first-line therapy for pelvic organ prolapse and stress urinary incontinence (SUI).

Objective: The primary objective was to determine if defecatory dysfunction was associated with pessary failure. The secondary objective was to determine other predictors of pessary failure.

Methods: This was a retrospective cohort study of all women undergoing first pessary placement at one academic center from April 2014 to January 2017. Defecatory dysfunction was defined as the presence of constipation, rectal straining, rectal splinting, and/or a feeling of incomplete defecation. Data were extracted from a standardized new patient intake form and the Pelvic Organ Prolapse Distress Inventory short form (PFDI-20) which all new patients complete at their first office visit. Pessary failure was defined as <1 year of pessary use and not using at most recent visit.

Results: Charts of 1092 women were reviewed and 1071 were included. Women who failed the initial pessary fitting were excluded. Mean age was 62±15 years, mean BMI was 28±6 kg/m2, mean parity was 2±1, with 68% Caucasian, 73% menopausal, and 41% sexually active. Reason for pessary use included pelvic organ prolapse (46%), SUI (24%), or both (30%). Overall pessary failure rate was 77%. The overall rate of defecatory dysfunction, as defined above, was 45%. Factors associated with pessary failure included defecatory dysfunction symptoms of incomplete defecation (p<.001) and rectal splinting (p=.001), as well as rectocele (p=.031), fecal incontinence (p=.002), diarrhea (p=.046), absence of bulge symptoms (p<.001), lesser degree of prolapse on exam (p=.003), SUI as reason for pessary use (p<.001), younger age (p<.001), Hispanic race (p=.001), and being sexually active (p<.001). In a logistic regression model, defecatory dysfunction in the form of incomplete defecation remained significantly associated with pessary failure (OR 3.29, 95% CI 1.43, 7.52). Other factors that remained significantly associated with pessary failure were absence of bulge symptoms (OR 2.18, 95% CI 1.22, 3.90) and younger age (OR 1.02, 95% CI 1.02, 1.05).

Conclusions: Pessary failure was common, with over two-thirds of the study population not achieving long-term use. Defecatory dysfunction in the form of incomplete defecation had the strongest association with pessary failure. Women with incomplete defecation were three times as likely to discontinue pessary use compared to those without this form of defecatory dysfunction. Other predictors of pessary failure included absence of bulge symptoms and younger age. Understanding predictive factors of pessary failure may help guide clinicians and patients when choosing treatment options for pelvic floor dysfunction.

Disclosure:

Work supported by industry: no.

047

Perineal trauma in subsequent delivery after previous obstetric anal sphincter injury: A multi-centre study

D'Souza, J 1 ; Monga, A 1 ; Tincello, D 2

1: University of Southampton, NHS Foundation Trust; 2: Department of Health Sciences, University of Leicester

Introduction and hypothesis: Obstetric anal sphincter injuries (OASIS) result in significant morbidity and are a contributing factor for anal incontinence and faecal urgency. Evidence for risk of recurrence is limited. We aim to investigate whether there are key factors influencing the risk of recurrence of OASIS.

Methods: Univariate and multivariate logistic regression analysis of prospectively collected data from electronic maternity databases. Data included all primiparous women sustaining OASIS during a singleton, term, cephalic, vaginal delivery that had a subsequent delivery, from four hospitals between 2004 and 2015.

Results: A total of 2272 women met the criteria, of whom 10.2% of those delivering vaginally had a repeat OASI. 59.4% had a second degree tear. Positive predictors for recurrent injury were increased birthweight and maternal age at both index and subsequent deliveries, a more severe degree of initial OASI and Asian ethnicity. The overall mediolateral episiotomy (MLE) rate was 15.6%; 77.2% of those having episiotomy had in no spontaneous perineal trauma. Only 4.4% of women with recurrent OASIS had a MLE, whilst the MLE rate was 16.9% in those without a recurrence (p<0.001). MLE at subsequent delivery decreased the risk of recurrent injury by 80%. Birthweight greater than 4Kg increased the risk by 2.5-times. Women having an elective caesarean section were more likely to be Caucasian, older, have previously had an operative vaginal delivery and a more severe degree of OASI.

Conclusion: Women with previous OASIS are at an increased risk of recurrence. Recommendation for more liberal use of MLE in Obstetric practice could decrease the risk of recurrence.

References

  1. 1.

    Int Urogynecol J 2014;25:1621–7.

  2. 2.

    BJOG 2014;121(13):1695-703

  3. 3.

    RCOG GTG No.29, 2015

Disclosure:

Work supported by industry: yes, by University of Southampton, NHS Foundation Trust.

048

Episiotomies and perineal tears: Womens perspective

Karantanis, E 1 ; Alexander, J 1 ; Manners, M 2 ; Turner, R 3 ; Faasse, K 3

1: St George Hospital, Sydney; 2: St George Hospital; 3: University of New South Wales

Introduction: Episiotomies are increasing in frequency to minimize obstetric anal sphincter injuries. Obstetricians and Midwives often worry about whether laboring women are consenting if an episiotomy is considered. Information about women’s attitude to and acceptance of episiotomy is sparse and such information can help guide obstetric management.

Objectives: We aimed to determine the acceptability of episiotomy to pregnant women, the degree of importance of information about episiotomies, and the effects of information on comfort and anxiety levels approaching delivery.

Methods: Nulliparous women in their third trimester were provided evidence-based information packages about episiotomies including pre and post information questionnaires developed by a psychologist, statistician with consumer review. Comprehension, attitudes to episiotomy, and anxiety levels were compared before and after the information packages.

Results: There were 105 responses to the survey. 88% of women surveyed would accept an episiotomy, 10% said they did not have enough information, and 2% said they would decline. 81% of women agreed that the information helped them understand more about childbirth. 62% agreed that they felt more comfortable with the birthing process after reading the material though 10% disagreed with that statement. Only 1 responder disagreed with the statement that this was important information to provide to women. There was no significant difference in changes in anxiety toward episiotomy pre and post information although there was a 38% reduction in the number of women who reported high or very high anxiety prior to the questionnaire. There was no difference in anxiety for episiotomy compared with a perineal tear although slightly more women suggested they would prefer an episiotomy over a perineal tear. Only 6% of women were prepared to risk a third or fourth degree tear rather than have an episiotomy. Data collection and analysis will be complete over the upcoming weeks.

Conclusion: The majority of women accepted an episiotomy if required. The most common reason for this was for the safety of themselves or the baby. Many women describe moderate to very high levels of anxiety approaching childbirth but particularly towards perineal tears, episiotomies and caesarean section. Though analysis is incomplete, written information appears to reduce anxiety in women with high or very high anxiety levels. As most women found the information helped them feel more comfortable approaching childbirth and the vast majority considered the information to be of importance, it is possible that continuing to refine and expand the information given to women will be beneficial in empowering patients to make informed decisions during labour and delivery. The supplementation of antenatal care with written material should not significantly increase the workload of doctors and midwives in already burdened antenatal clinics. We can infer that new national guidelines to require episiotomies for all instrumental deliveries on nulliparous women will be well received by women if they are educated with appropriate antenatal materials. A questionnaire also identifies the conscious and informed objectors in whom episiotomy must be avoided.

Disclosure:

Work supported by industry: no.

049

Potential role of pre-stage diabetes in the development of overactive bladder: Analysis of a health screening program in men and women

Aoki, Y 1 ; Okada, M 1 ; Ito, H 1 ; Kusaka, Y 1 ; Yokoyama, O 1

1: University of Fukui Faculty of Medical Sciences

Objective: This study examined the relationship between OAB with FPG and HbA1c, as well as other markers of cardiovascular risk including dyslipidemia, obesity, hypertension and comorbidities, in a population based health screening program.

Methods: A cross-sectional questionnaire survey assessing the role of pre-stage diabetes on OAB was conducted. We collected data on participants aged 40-69 years who participated in a multiphasic health screening, from April 2015 to March 2016, with written informed consent. All participants underwent a detailed health evaluation, including age, body mass index (BMI), blood pressure, a blood laboratory study, and current medical therapies including medication for diabetes, hypertension, and dyslipidemia. A blood laboratory study evaluated FPG level, HbA1c, Triglyceride, and HDL cholesterol. All participants were asked to answer a standardized self-reported questionnaire for OAB screening (SQOAB, Screening Questionnaire for Overactive Bladder). One of the screening questions we used is “It is difficult to hold on when I have the sudden compelling desire to urinate” with a choice of the following two responses: yes or no. Participants who answered ‘yes’ were identified they had OAB. Baseline characteristics of the study population were calculated both overall and according to categories of with or without OAB. Subjects were stratified into three 10-years age groups (40-49, 50-59, and 60-69 years). Univariate analyses were initially performed to assess the relationships between OAB and the characteristics or associated health factors including FPG and HbA1c. Variables were added simultaneously to multivariable regression models. We report the OR and 95% confidence interval (95%CI) for the multivariable logistic regression, with a p-value of <0.05 regarded as statistically significant.

Results: A total of 6,133 individuals aged 40-69 years were participated in in a multiphasic health screening. Of all participants, we excluded 353 participants with prior diagnosis of diabetes and 9 participants without complete response for the questionnaire, leaving a sample of 5,771 participants (2,298 males and 3,473 females) for analysis. Median age was 65 years. Overall, 189 men (8.2%) and 409 women (11.8%) reported urgency. Multivariate regression showed that even modestly raised FPG (110-125 mg/dL) and HbA1c (5.5-5.9%) levels were independent associated with OAB in women (OR 1.46 (1.04-1.83, 95%CI) compared with FPG <100 mg/dL, and OR 1.31 (1.04-1.65, 95%CI) compared with HbA1c of <5.5%, respectively) (Figure). No statistical difference was found between FPG/HbA1c levels and OAB in men.

Conclusions: These results suggested that the level of FPG and HbA1c was significantly correlated with OAB even at the stage where it is not confirmed as a diabetes in female population. Pre-stage diabetes has a possible role in the development of OAB.

figurez

Figure. Multivariate analyses of the risk factors for OAB in women.

Disclosure:

Work supported by industry: no.

050

Features of fecal incontinence in patients with coexisting pelvic floor dysfunction

Savitt, L 1 ; Cauley, C 1 ; Wakamatsu, M 1 ; Weinstein, M 1 ; Von Bargen, E 1 ; Bordeianou, L 1

1: Massachusetts General Hospital

Introduction: Many patients with fecal incontinence (FI) report co-existing constipation. Surprisingly, the impact of this superimposed disease on FI patients has not been well characterized or understood. Furthermore, treatment recommendations for this subgroup of FI patients have not been formulated.

Objective: This study aims to 1) report the frequency of this phenotype of FI and 2) compare quality of life outcomes of FI patients with and without concurrent constipation.

Methods: This is a single institution prospective cohort study from January 2007 to January 2017. 1399 patients with FI were identified. Of these, 946 (67.6%) completed the Fecal Incontinence Severity Index (FISI) survey. 656 (69.3%) had coexisting constipation measured by the Constipation Severity Instrument (CSI). The FISI, the impact of FI on quality of life (FIQOL), the rate of coexisting pathology (measured by the Pelvic Organ Prolapse Inventory (POPIQ-7) and Urinary Distress Inventory (UDI-6) surveys) were compared between FICA (constipation absent) and FICP (constipation present) groups.

FISI scores were divided into quartiles, and FIQOL scores were thematically categorized: lifestyle, coping, depression, and embarrassment. To determine the impact of increasing CSI scores on FIQOL, 4 independent linear regression models were developed for each FIQOL theme. Models were adjusted for FISI score quartile, POPIQ 7, and UDI-6 scores. Finally, manometry and defecography data was reviewed and FICP versus FICA phenotypes compared.

Results: FICP patients (CSI score of 33.1 +/- 15.3) were more likely to report family history of constipation (31.3% vs 9.3%, p=0.01) and less likely to report a history of pregnancy (89.2% vs 91.4%, p=0.001) or complicated delivery, such as those requiring instrumentation for extraction, (9.1% vs 18.1%, p=0.005) when compared to FICA patients. FICP patients reported higher rates of pelvic pain (37.3% vs 14.9%, p<0.001), bladder pain (21.9% vs 11.5%, p<0.001), and abdominal pressure (57.0% vs 27.8%, p=0.001). In addition, FICP patients had higher rates of coexisting pelvic organ prolapse (POPIQ-7 18.4 vs 8.2, p<0.01) and urinary incontinence (UDI-6 30.2 vs 23.4, p=0.01). FICP patients also had statistically different physiology and defecography results (Table).

In addition, FICP patients had better FISI scores at presentation (21 vs 23.8, p <0.001) yet lower satisfaction with their health (28.9% vs 42.5, p<0.001). For each FISI quartile, FIQOL scores in FICP patients were worse as CSI increased: FIQOL-lifestyle (-0.013 (-0.018, -0.009) p<0.001); FIQOL-coping (-0.012 (-0.017, -0.007) p<0.001), FIQOL-depression (-0.022 (-0.027, -0.018) p<0.001), FIQOL-embarrassment (-0.007 (-0.012, -0.002) p=0.004). Coexisting pathology worsened FIQOL scores even further.

Conclusions:

FI patients with concurrent constipation represent a different disease phenotype from patients with isolated FI. They have a different constellation of symptoms, different medical and family histories, different manometric and defecography findings and worse overall QOL. In addition, they have higher rates of co-existing pelvic organ prolapse and urinary dysfunction. Treatment of FICP patients requires careful exclusion of prolapse pathology with coordinated treatment of co-existing disorders.

Table:

Anorectal Physiology Testing/Defecography Findings All patients with Fecal Incontinence Who Underwent Particular Test FICP (Fecal Incontinence Patients with Constipation Present) FICA (Fecal Incontinence Patients With Constipation Absent) P value
Mean Resting Pressure 609 (64.4%) 56.8 ± 25.2 44.9 ± 20.4 <0.001
Maximum Resting Pressure 611 (64.6%) 78.8 ± 30.3 66.6 ± 26.2 <0.001
Maximum Squeeze Pressure 613 (64.8%) 138.1 ± 55.4 120.3 ± 51.1 <0.001
Inability to Expel Balloon 469 (49.6%) 117 (27.7%) 23 (11.4%) <0.001
Paradoxical EMG 575 (60.7) 147 (37.5%) 161 (28.0) <0.001
Intussuception/intra-rectal 140 (14.8) 26 (40%) 8 (88.9%) 0.005
Intussuception/intra-anal 39 (60%) 1 (11%) 0.005
Intussuception/rectocele 75 (61.5%) 8 (44.4%)

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Work supported by industry: no.

051

Differentiation of skeletal muscle myocytes from patient-specific, induced pluripotent stem cells derived from urine of women with stress urinary incontinence

Kibschull, M 1 ; Nguyen, T 1 ; Chow, T 1 ; Lye, S 1 ; Drutz, H 2 ; Alarab, M 3 ; Rogers, I 1 ; Shynlova, O 1

1: Sinai Health System / Lunenfeld-Tanenbaum Research Institute; 2: Baycrest Health Sciences; 3: Sinai Health System / Urogynecology

Introduction: Stem cell therapy holds great promises in human regenerative medicine. Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are two major pelvic floor disorders (PFD) with potential application of stem cells for regeneration of pelvic floor tissues and urethral muscle for regaining its function. However, the derivation of autologous human tissue stem cells is associated with technical challenges regarding the choice of tissue biopsies, culture conditions for the enrichment of specific cells, and their capacity to integrate into the patients’ target tissues. To circumvent the problem with primary cells derived from SUI patient’s muscle biopsy, we reprogrammed urine cells into induced pluripotent stem cells (iPSC) which can be differentiated into various cell types for therapy of PFD. We reported previously the differentiation of iPSC into fibroblasts for PFD treatment. Here, we describe the differentiation of iPSCs derived from urine cells of women with SUI to skeletal muscle myocytes for future urethral sphincter regeneration.

Objective: To use patient-specific iPSC cells - reprogrammed from urine cells of women with SUI - for differentiation of skeletal muscle cells.

Methods: Urine-derived iPSC from women with SUI (and the embryonic stem cell lines H9 as control) were differentiated into early embryonic mesoderm using the small-molecule GSK-3b-inhibitor CHIR99021. After >60 days in culture, cells were tested for the presence of myocytes. Success of the myogenic differentiation was monitored by quantitative PCR (qPCR) for specific gene expression and immunocytochemistry (ICC) for skeletal muscle lineage markers.

Results: We tested three published protocols for skeletal myocyte differentiation and adapted the Choi et al (2016) protocol to differentiate skeletal muscle cells from urine-derived iPSC lines. An optimum of 3 days of CHIR99021 treatment for induction of early mesodermal differentiation from iPSC, indicated by expression of the early mesodermal lineage ‘T’ gene (human brachyury homologue), was used. After continuous culture in chemically-defined, selective media for >30 days, differentiation along the mesodermal lineage as was confirmed by specific markers Pax3, Pax7 MyoD, MyoD, Myh3 and desmin. After >80 days of culture we detected skeletal muscle myocytes, which was confirmed by ICC detection for skeletal muscle markers MF20, PAX7, MyoD, MyoG and NCAM1. Moreover, transferring myocytes into specific maturation medium initiates their differentiation and fusion into multi-nucleated myotube structures that stain positive for Titin and fast skeletal troponin T protein (TNNT3).

Conclusions: We present here a proof that iPSC derived from urine cells can be differentiated in vitro into skeletal muscle cells that have the ability to further differentiate into multi-nucleated myotubes. This confirms that the iPSC technology has the capacity to derive specific cell types – here skeletal muscle cells – that can be used in tissue regeneration, i.e. injured urethral sphincter muscle therapies of patients with SUI. Importantly, iPSC serves as an unlimited source of stem cells for regenerative medicine, avoiding the use of muscle biopsy and problems with primary cell culture (senescence, loss of proliferation). Patient-specific skeletal muscle myocytes derived from iPSC of women with PFD have a great potential in regeneration of urethral and supporting pelvic floor muscles.

Disclosure:

Work supported by industry: no.

052

Clinical effectiveness and safety of surgical treatments for stress urinary incontinence: A network meta-analysis

Saraswat, L 1 ; Brazeelli, M 2 ; Imamura, M 2 ; Hudson, J 2 ; MacLennan, G 2 ; Vale, L 3 ; Craig, D 4

1: Aberdeen Royal Infirmary; 2: University of Aberdeen; 3: Cochrane Incontinence Group; 4: Newcastle University

Introduction: Stress urinary incontinence (SUI) is a common condition that can have a profound impact on the quality of life of affected women. There are currently nine different surgical techniques that can be used to treat stress urinary incontinence. While some techniques are used more often than others, there is currently no consensus amongst decision-makers, doctors and patients about which surgical technique is most effective and the safest. Previous research has not helped to resolve this uncertainty around choice. This is because research to date has focused on the individual surgical techniques, rather than comparing all of the techniques with each other.

Objective: The aim of this research is to evaluate the clinical effectiveness and safety of all existing surgical interventions for stress and stress-predominant mixed urinary incontinence in women.

Methods: A systematic review and network meta-analysis of clinical effectiveness and safety of nine different surgical interventions for stress urinary incontinence was conducted. RCTs were identified from existing Cochrane reviews and literature searches based on the Cochrane Incontinence Group Specialised Trials Register. The surgical interventions assessed were open and laparoscopic colposuspension, traditional suburethral slings, retropubic and transobturator mid urethral slings, single incision slings, anterior vaginal repair, bladder neck needle suspension and periurethral bulking agents. Network meta-analysis (NMA) was employed to combine direct and indirect evidence to allow an estimate of treatment effects for interventions where no direct head-to-head clinical trials have been conducted. This analysis will provide relative treatment effects for all comparisons. Data on adverse events were collected and analyzed using pair-wise meta-analyses. Risk of bias was assessed using the Cochrane risk-of-bias tool. Primary outcome was defined as cure (resolution of incontinence symptoms) at 12 months. Secondary outcomes included perioperative complications, voiding dysfunction, repeat continence surgery and long term adverse effects such as persistent pain or dyspareunia.

Results: The NMA included 175 RCTs that provided data on surgical treatment of SUI. The RCTs varied considerably in sample sizes, duration of follow up and risk of bias. The NMA results suggest that both traditional slings and retropubic mid-urethral slings (MUS) were more effective than other interventions in curing the symptoms of stress urinary incontinence. The surface under the cumulative ranking curves for traditional sling and retropubic MUS showed that 89.4% and 89.1% of women were cured respectively. However, the credible intervals around the estimated odds ratios from the NMA showed some degree of uncertainty. Data for adverse events were limited and provided little evidence of a difference between interventions.

Conclusions: Retropubic MUS and traditional slings are the most effective surgical interventions in resolving symptoms of SUI compared with other available interventions. Trials with longer duration of follow up that provide data on long term adverse outcomes such as pain are required to conduct risk benefit analysis for different surgical interventions and further aid decision making.

Disclosure:

Work supported by industry: no.

053

Can lumbosacral magnetic resonance imaging be performed safely in patients with a sacral neuromodulation device?

Pizarro-Berdichevsky, J 1 ; Guzman-Negron, JM 2 ; Gill, B 2 ; Goldman, HB 2

1: Urogynecology Unit H. Sotero del Rio - Division de Obstetricia y Ginecologia, Pontificia universidad Catolica de Chile; 2: Cleveland Clinic Lerner College of Medicine, Cleveland,

Introduction and Objectives: Historically, the use of magnetic resonance imaging (MRI) in patients with sacral neuromodulation (SNM) devices has been limited. Currently the Medtronic InterstimTM II model only has FDA approval for 1.5 Tesla (T) MRI head scans.

Objective: was to determine the safety of SNM in patients during lumbosacral 1.5 T MRI.

Methods: We prospectively recruited SNM implanted patients requiring lumbosacral or pelvic 1.5 T MRI. Before MRI, patients completed validated urinary symptom questionnaires and a survey regarding their usual SNM sensation. The implantable pulse generator (IPG) was interrogated, with impedances, battery life, and stimulus amplitude sensory thresholds assessed pre and post-MRI. Devices were switched off prior to entering the scanner. Patients were monitored during the MRI study and an MRI-related adverse events questionnaire was completed post-MRI. Validated questionnaires were repeated 1 month after MRI to assess for changes in SNM therapeutic efficacy.

Results: Eleven patients were enrolled in the study. All patients underwent lumbosacral MRI with lower back pain 55% (6/11) being the most common indication for the study. Immediately after MRI only 1 patient reported mild discomfort at the site of the IPG during the MRI, which was only present during the scan and not afterward. Two patients reported warmth at the the IPG site during the scan, which also was only present during scanning. No patients experienced sensations of stimulus or movement at the IPG site, nor were any paresthesias reported. There were no major changes in impedances or battery life with MRI. Stimulus amplitude sensory thresholds and localization of stimulation were unchanged. Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaires (IIQ-7) 1 month after MRI did not show worsening scores compared to pre-MRI scores. None of the patients reported a negative Patient Global Impression of Improvement (PGI-I) score 1 month after MRI.

Conclusion: No significant adverse events occurred in patients implanted with an SNM device who underwent a 1.5 T lumbosacral MRI scan. Therapeutic efficacy of SNM was unchanged 1 month after this imaging.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Medtronic).

054

Inhibition of Rho kinase by GSK 269962 reverses both corticosterone-induced detrusor overactivity and depression-like behaviour in rats

Wrobel, A 1 ; Jankiewicz, K 1 ; Rechberger, E 1 ; Skorupska, K 1 ; Miotla, P 1 ; Semczuk, A 1 ; Kulik-Rechberger, B 2 ; Rechberger, T 1

1: Second Department of Gynecology, Medical University of Lublin, Jaczewskiego 8, PL 20-090 Lublin, Poland; 2: Department of Pediatric Propedeutics, Medical University of Lublin, Gębali 6, PL 20-093 Lublin, Poland

Introduction: Literature data give clear evidence that upregulated RhoA/Rho-kinase (ROCK) signalling is one of the factors that may lead to the development of detrusor overactivity and various disorders of the central nervous system. In neuronal cells, the excitatory glutamate activates ROCK and ROCK inhibition may exert a neuroprotective effect against glutamate-related excitotoxicity. Moreover, a decreased expression of several Rho/ROCK pathway components in the frontal cortex after acute single administration of serotonin re-uptake inhibitors, serotonin/norepinephrine re-uptake inhibitors, and tricyclic antidepressants has been found. A role of ROCK in the regulation of muscarinic M3 receptor-mediated detrusor contraction has been also demonstrated. It was proven that ROCK inhibitors prevent contractions in rat bladder strips evoked by carbachol and reverse detrusor overactivity in distinct in vivo models. Moreover, there are reports of lowering the basal tone of the bladder by ROCK inhibitors in the absence of exogenous stimulation, which indicates the role of ROCK signalling in keeping the basal tone of the bladder.

Objective: The main objective of our study was to investigate whether the administration of a ROCK inhibitor – GSK 269962 could reverse the corticosterone (CORT)-induced detrusor overactivity and depressive-like behaviour in animals, as well as undo the changes in pro-inflammatory and anti-inflammatory cytokines in serum, urinary bladder, hippocampus, prefrontal cortex, and Barrington’s nucleus. Brain structures selected for testing play an important role in the aetiopathogenesis of depression and in voiding control. Previous studies confirmed that 14-day administration of CORT via parenteral route is a reliable procedure to produce detrusor overactivity symptoms in rats without causing any histopathological alterations in the urinary bladder, and for obtaining a depressive phenotype in the forced swim test. This in vivo model is responsive to standard antimuscarinic and antidepressant agents. GSK 269962 was used, since it displays greater than 30-fold selectivity for ROCK against a panel of serine/threonine kinases. 10 mg/kg/day of this agent (i.e., a dose applied in the study) inhibits both ROCK1 and ROCK2 isoforms without affecting other kinases participating in detrusor contraction.

Methods: The experiments were carried out on female Wistar rats. Surgical procedures, conscious cystometric investigations, biochemical analyses, and behavioural studies (measurement of the locomotor activity and forced swim test) were performed.

Results: Administration of corticosterone at a daily dose of 20 mg/kg for 14 days increased the immobility time of animals in the forced swim test, induced changes in the cystometric parameters specific to detrusor overactivity, elevated concentrations of the pro-inflammatory cytokines (IL-1β, IL-6 and TNF-α) and reduced level of the anti-inflammatory cytokine IL-10 in serum, urinary bladder, and various brain structures (i.e., hippocampus, prefrontal cortex, and Barrington’s nucleus). Inhibition of ROCK by 7-day treatment with GSK 269962 (10 mg/kg/day) reversed the symptoms of both detrusor overactivity and depression as well as normalized levels of the tested biomarkes.

Conclusions: The outcomes of the study confirmed a close connection between depression and detrusor overactivity. The findings encourage the idea of ROCK inhibitors as a potential future treatment option for overactive bladder accompanied by depression.

Disclosure:

Work supported by industry: no.

055

A pilot study on pelvic floor symptoms in women living with female genital Mutilation/Cutting: preliminary results

Uebelhart, M1; Boulvain, M1; Dällenbach, P1; Petignat, P1; Abdulcadir, J1

1: HUG

Introduction: Female Genital Mutilation/Cutting (FGM/C) can have significant, negative psychophysical health consequences, some of which, could increase the risk of developing pelvic floor symptoms (urinary, colorectal, pelvic and vaginal). Specific uro-gynecological long term conditions related to FGM/C are reported in the literature, especially in case of type III (infibulation), and include dysuria, obstructive micturition, long term micturition efforts and overactive bladder. Women living with FGM/C are also reported to be at increased risk of negative obstetric outcome, including episiotomy, prolonged second stage of labour, obstructed labour, perineal tears and 3rd degree tears. They are often multiparous, live in low-income countries, where obstetric access and care can be delayed or lacking and can experience early marriages and early pregnancies with possible additional negative perineal consequences. Also, women with FGM/C have been found at increased risk of other past traumatic life events, especially sexual traumas such as forced marriage and rape, with a potential additional negative impact on the pelvic floor function. FGM/C can cause both psychosexual and physical consequences including pelvic floor disorders that can significantly impact women’s life quality.

Objective: To determine the prevalence of pelvic floor symptoms and disorders among women with FGM/C and test available validated questionnaires.

Methods: Cross sectional study started in April 2016, in our Department of Gynecology and Obstetrics on 121 women with different types of FGM/C. The sample size is based on an expected proportion of 20% of pelvic floor disorders in a population of women with FGM/C in their thirties, with a α =0.05, 80% power and W=0.15. Inclusion criteria are: having undergone FGM/C, age ≥18, no use of oestrogens and/or androgens, no previous history of hysterectomy. Six validated questionnaire scores (PFDI-20, PFIQ-7, PISQ-IR, FGSIS, FISI, and Wexner constipation questionnaire) and sociodemographic information are collected. The questionnaires are administered in French or in English by the investigators, when needed with a certified and accepted female interpreter. The scores of the questionnaires validation studies on women without FGM/C with or without pelvic floor symptoms are used as reference. All women undergo a urogynecological examination including vulvar inspection to classify the FGM/C type according to the World Health Organization Classification. In case of pelvic organ prolapse (POP), this is classified according to the Pelvic Organ Prolapse Quantification System.

Results: Data on 60 women are presented as preliminary results. Fourteen (23%) have FGM/C type 3. The remaining women have FGM/C type 1, 2 or defibulated (opened-up) type 3. Only two women presented a POP at stage ≤2. Forty five percent of women referred other past traumatic sexual, psychological or physical events different than FGM/C or forced marriage. Women with FGM/C reported questionnaires’ scores indicating a negative impact on the quality of life due to pelvic floor symptoms (PFDI-20 and PFIQ-7) and a low satisfaction of the genital self-image (FGSIS).

Conclusions: Preliminary results indicate that women with FGM/C report scores similar to those of women without FGM/C who experience pelvic floor symptoms and disorders, even though they do not present a POP.

Disclosure:

Work supported by industry: no, by N/A.

056

Heterogeneity in cost estimates reported for SUI treatments

Zwolsman, S 1 ; Kastelein, A 1 ; Daams, J 1 ; Opmeer, B 1 ; Roovers, J 1

1: AMC

Abstract

Introduction: There is an increased demand for an international overview of cost estimates and insight into the variation affecting these estimates.(Sculpher,2004) In this review we provide an overview of cost estimates for different components in the diagnosis, treatment and follow-up of SUI. Understanding of these costs is useful for cost-effectiveness analysis (CEA) research of new treatment modalities and for clinical guideline development.

Objective: To provide an overview of unit cost estimates for healthcare utilization by SUI patients, explore variation affecting these estimates and present a quality standard for determination and reporting of cost estimations.

Methods: Systematic review of economic evaluations of SUI. A systematic search was conducted in 'Ovid Medline & other non-indexed materials' and 'Ovid Embase' for articles published between 1995 and 2017. The NHS-EED filter and the McMaster sensitive therapy filter were combined with a SUI search strategy. Cost estimates were converted into 2017 NL Euros using inflation rates and purchasing power. We extracted unit cost estimates, assessed variability and methodology and determined transferability.

Results: We included 37 studies in this review. 482 Cost estimates from 13 countries worldwide were extracted. Descriptive analysis show that hospital stay in gynaecology ranged between €82 and €1,292 per day. Cost for gynaecological consultation range from €30 in France to €158 in Sweden. In the UK costs are estimated at €228 per hour. Cost for a TVT device range from €431 in Finland to €994 in Canada. TVT surgery per minute costs €25 in France to €82 in Sweden. Total costs for TVT range from €1,224 in Ireland to €9,878 for inpatient care in Sweden. Outpatient TVT placement costs €5,435 in Sweden as compared to €1,437 in France. Variation was explored.

Conclusion: Cost prices for SUI treatment range both within and between countries. CEAs of SUI interventions cannot be interpreted without bias when the base of these analyses – namely costs – cannot be compared and generalized. Heterogeneity was observed in costs estimates for all units at all levels of health care. Available CEA results are most valid for the particular health care contexts where the costs were derived from. Of course, costs that were more commonly reported were easier to compare. Methodology of economic evaluation research would benefit from quality standards as proposed in this review to reduce methodological heterogeneity. Therefore, when costs have not been adjusted for inflation and purchasing power, the outcome of this CEA cannot be applied to other countries. Also, both researchers and clinicians should make sure that the source of cost prices used in research have a clear description and are reliable. Reviewed CEAs should be interpreted with care. More standardised methods, taxonomy and definitions will enhance transferability to other contexts.

Reference:

Sculpher, M., Pang, F., Manca, A., Drummond, M., Golder, S., Urdahl, H., Davies, L. & Eastwood, A. (2004). Generalisability in economic evaluation studies in healthcare: a review and case studies. Health Technology Assessment, 8(49), iii-iv,1-192.

Disclosure:

Work supported by industry: no.

057

Reducing obstetric anal sphincter injuries in a tertiary hospital with high perineal support rate

Saavedra Arcas, JA 1 ; Barrero de Marcos, AC 1 ; Bernaldo de Quiros Huguet, I 1

1: Hospital Universitario Nuestra Señora de Candelaria

Introduction: Obstetric anal sphincter injuries (OASI) are associated with significant short-term and long-term morbidity. During the past decade, a continuous rise in the rate of OASI has been reported. As a response to the need to reverse this trend, researchers have focused on perineal support during the second stage of labour. The perineum protection technique has become a main protective factor. However, at the same time, in our centre with a protection rate over 95 percent, there was a compelling need to identify and evaluate other strategies to minimize OASI. Since 2010 we implemented the National Guideline for the Management of Normal Vaginal Labour and Delivery and performed regular workshops on Prevention, Identification and Repair of OASI.

Objective: The aim of this study was to determine the effect of maternal and obstetric characteristics on the incidence of OASI in the last five years.

Methods: We conducted a retrospective observational study on all woman with a planned singleton, term, cephalic vaginal delivery within our obstetric unit between 2013 and 2017. Maternal, obstetrical and foetal risk factors for OASI were collected from the hospital obstetric database. Univariate analyses and multivariate logistic regression analyses, presenting adjusted odds for OASI, were performed. Incidence of obstetric anal sphincter injuries, defined as third or fourth degree perineal lacerations, was the primary outcome.

Results: From January 2013 to December 2017, 11121 women underwent singleton vaginal delivery. The OASI rate decreased from 2,81 % in 2013 to 1,81% in 2017 while the episiotomy rate suffered a drop of 38% (from 44,5 to 17,16%). This reduction could not be explained by change in population characteristics (nulliparity and maternal age) or other OASI risk factors (operative deliveries, epidural analgesia and birth weight) during the study. The overall perineal protection rate remained stable (>95%).

Conclusions: The marked reduction in OASI rate in our study could be explained by three factors: the lower episiotomy rate, the performance of workshops on Prevention, Identification and Repair of OASI during the last decade and the continuous use of active perineal protection.

Disclosure:

Work supported by industry: no.

058

The impact of bariatric surgery on urinary incontinence: A systematic review and meta analysis

Purwar, B 1 ; Cartwright, R 2 ; Cavalcanti, GDA 3 ; Digesu, GA 4 ; Fernando, R 4 ; Khuallr, V 4

1: Singleton Hospital, Swansea, UK; 2: John Radcliffe Hospital, Oxford, UK; 3: Federal University of Pernambuco and Oswaldo Cruz University Hospital (University of Pernambuco - Recife - Brazil); 4: Imperial College Hospitals NHS Trust, London, UK

Introduction: Obesity is a growing pandemic with a huge burden of associated harmful effects on health. Overweight and obese patients are at risk of all lower urinary tract symptoms including stress and urgency urinary incontinence (UI). Improvements in urinary incontinence have been reported after weight loss, with the most significant effect on stress urinary incontinence (1, 2).

Objective: We aimed to systematically review and meta-analyse all available studies reporting the effect of surgically induced weight loss on urinary incontinence.

Methods: We searched for studies including women with urinary incontinence that had undergone bariatric surgery. Medline, Embase, and the Cochrane library were systematically searched using pre-defined criteria for relevant studies up to September 2016. Two independent reviewers categorized studies as either low or high risk of bias using a novel instrument specifically designed for longitudinal symptom studies aimed at the general population. Disagreement was resolved by consensus. We screened 105 abstracts and retrieved 35 full text articles. Twenty-three studies (n=3225) were included were included for meta-analysis. Different urinary symptom questionnaires employed in different studies were standardised on a scale of 0-100 to enable pooling We calculated the weighted mean difference for urinary quality of life scores and weighted overall pooled estimates for proportions of women cured. Data were analysed using metan, metafunnel and metareg for Stata 14 using random effects models.

Results: There were no randomised controlled trials identified. Included studies had enrolled women aged <70 years with BMI > 35. As compared to pre-operative BMI, BMI dropped by mean difference of 2kg/m2 after the bariatric surgery (P<0.0001).The urinary scores of patients were improved in all studies (WMD= -14.79;CI= -18.47 to -11.11, p<0.0001) but with substantial heterogeneity (I2 =87.1%). The pooled proportion of women cured of any UI was 59% (95% CI= 51% to 66%) and the proportion of women cured of SUI was 55%(95% CI= 40% to 70%). Results were unchanged in sensitivity analyses excluding each study once. We explored heterogeneity using metaregression, testing the type of bariatric surgery and change in BMI as predictors of effect size, neither of which were significant predictors. Differences between studies may therefore relate to different sampling approaches and choice and timing of outcome assessments.

Conclusion: Evidence from cohort studies suggests that there is a clinically meaningful improvement in urinary symptom scores, proportion of women cured of SUI and any UI and reduction in BMI after bariatric surgery, but with substantial differences between studies. Further studies are needed to explore how bariatric surgery impacts on individual subtypes of incontinence, and to investigate which types of surgery offer the largest benefit for LUTS.

1.Obes Rev;15(7):610-7.

2.JAMA Intern Med;175(8):1378-87.

figureaa

Figure 1: Forest plot displaying mean change in urinary scores after bariatric surgery based on type of surgery.

figureab

Figure 2: Meta-analysis of proportions of women cured of Any UI after bariatric surgery (Metaprop)

Disclosure:

Work supported by industry: no.

059

Somatic and psychological triggers for irritative bladder symptoms: Men are from Mars, women are from Venus?

Zilberlicht, A 1 ; Boms-Yonai, N 1 ; Haya, N 1 ; Feferkorn, I 1 ; Lavie, O 1 ; Abramov, Y 1

1: Carmel Medical Center, Rappaport Faculty of Medicine, Technion University

Introduction: Overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. Somatic and psychological triggers have recently been reported in patients with OAB1.

Objectives: The current study aimed to determine the prevalence of these triggers among middle-aged men and women without OAB.

Methods: This was a prospective study in which randomly selected middle-aged male and female volunteers without OAB were asked to fill the validated SOPSETO, UDI-6 and IIQ-7 questionnaires2. Individuals who had previously been diagnosed or treated for OAB were excluded. Statistical analysis was preformed to determine the prevalence of each trigger and its correlation to patients' quality of life (QoL). Given a confidence level of 95%, a power of 0.8 and assuming a correlation of 0.5, a sample of 40 men and 40 women was required.

Results: Forty men and sixty-six women were included. Three women and no men were excluded due to prior diagnosis of OAB. No statistically significant differences were found between men and women with regards to age (58+10 vs. 53+9 years), caffeine and total fluid consumption. There was a significantly higher prevalence of urinary urgency (41% vs. 19%, p=0.021), urge urinary incontinence (22% vs. 0%, p=0.002) and stress urinary incontinence (30% vs. 3%, p=0.001) among women as compared to men. Total UDI-6 (17+15 vs. 9+8, p=0.04) and IIQ-7 (10+21 vs. 4+15, p=0.02) scores were higher among women. Of the total 34 triggers evaluated 18 were ranked significantly higher among women than among men. There was a good correlation between the SOPSETO and the UDI-6 and IIQ-7 scores, primarily in women (r=0.46, p<0.0001; r=0.69, p<0.0001) but also in men (r=0.441, p=0.009; r=0.391, p=0.02).

Conclusions: Middle-aged women who have not been diagnosed with OAB still report irritative bladder symptoms more frequently than men of the same age group. Somatic and psychological factors are more likely to trigger these symptoms in women than in men and might add burden to their QoL.

References:

  1. 1.

    Neurourol Urodyn, 2017; 9999:1-6.

  2. 2.

    Neurourol Urodyn, 1995; 14: 131.

Disclosure:

Work supported by industry: no.

060

How does Manchester Health Questionnaire compare with clinical assessment at 3 months follow up visit after 3rd and 4th degree perineal tear repair? A 100 women observational study report

Subramaniem, A 1 ; Lingam, K 2 ; Hardwick, A 2 ; Knopik, K 3

1: Queens hospital Burton,NHS; 2: Queens Hospital Burton; 3: Queens hospital Burton

Introduction: We know that there is lack of evidence to inform decision making regarding the optimal mode of delivery following OASIS. About 17% of women develop worsening faecal symptoms after a second vaginal delivery if there had been faecal incontinence beyond 3 months but resolved by 6 months of index pregnancy. Availability of Endoanal ultrasound and anal manometry at follow up clinics for women who have had OASIS is not universal. Most units have limited resources and training to offer endoanal ultrasound or manometry for all women who sustain tears OASIS. Due to the nature of these investigations they are not always acceptable to some women. Manchester heath Questionnaire is a useful Quality of life assessment tool for faecal incontinence. We wanted to assess how the questionnaire results compare with clinical assessment in perineal tear review clinics.

Objectives: How does Manchester health questionnaire compare with clinical assessment? Can the Manchester health Questionnaire be useful in assessing need for further referral for colorectal investigations in women who have sustained 3rd and 4th degree perineal tears?

Methods: 100 women who had of 3rd and 4th degree tears were followed up 3 months after delivery in a dedicated post-natal review clinic between Jan 2015-Dec 2017. Manchester health Questionnaire was posted out and women were requested to complete prior to appointment. During clinic appointment direct symptom review and clinical examination was performed and decision was made to either refer for further investigations for endoanal ultrasound scan +/- manometry or discharge based on the clinical assessment alone, independent of questionnaire score. Manchester health Questionnaire scores were compared with clinical assessment results in each group of women and results analysed.

Results: Of the 100 women who were reviewed

Manchester health questionnaire score Number of patients Number referred for endoanal scan+/- anal Manometry on clinical assessment Percentage referred
3 or less than 3 44 7 16%
4 - 10 36 12 33%
11-20 7 4 57%
21 - 30 6 5 83%
>30 4 4 100%
Did not complete 3 1 n/a

The results as tabulated above showed that the Manchester scores compare favourably to clinical assessment. In those who had a score of 3 or less, after clinical assessment only 16% were referred for further assessments. All patients who scored above 30 were referred for further investigations and management to the colorectal team.

Conclusion: There is good correlation between the Manchester health Questionnaire and clinical assessment. It could be used as an adjunct to clinical assessment when making decisions for further referral especially in limited resource settings. If scores are high, patients could be offered the choice of referring directly for further investigations rather than wait for referral after review in perineal tear clinic, this may cut waiting times and help women resolve their issues sooner. Further studies are required to determine whether these results are reproducible in other settings. If this can indeed be used as a tool for assessing need for referrals further studies are needed to determine the exact cut off scores for referral.

Disclosure:

Work supported by industry: no.

061

What do the public think about vaginal mesh use? Content analysis of comments from online public forums after a programme on vaginal mesh on national television in the UK

Moloney-Geany, S 1 ; Cottam, A 1 ; ElHodaiby, M 1 ; Madhu, C 1

1: Southmead Hospital

Introduction: Vaginal meshes have been used in the management of pelvic organ prolapse and urinary incontinence. Whilst scientific studies have shown improved outcomes, some women develop serious complications, which can be debilitating. This has resulted in litigation and an increased scrutiny by the press, television, governments, health care providers and the patients themselves.

Objective: The aim of the study was to analyse public comments posted online about mesh use; to gain an insight into patient understanding and concerns over the use of mesh.

Methods: A television programme, Panorama (1) was broadcast by a national television in the UK (BBC) in December 2017 highlighting the serious complications of vaginal mesh use. National newspapers (UK) also reported on the content of the programme.

We identified public comments over a 2-month period after this telecast from newspapers, social media and internet forums discussing the programme and the use of mesh. A thematic analysis was performed from the available data. Ethical approval was not deemed necessary as the content was available on public forums and no patients were involved in the study.

Results: The overwhelming majority of the comments across all platforms were negative and tended towards anger. There were occasional comments regarding positive experiences of mesh, but the individual’s impression was that they were lucky not to have had a problem. The One of the main themes was that of distrust and frustration at the lack of transparency over the use of mesh and knowledge of complications. There were frequent mentions of the need for further investigation and a public enquiry. There were several comments calling for clarity in figures regarding the risks associated with mesh, the number of mesh implants used and the number of women who have experienced mesh complications. There were concerns about the lack of trial and safety data prior to the implants being implemented into practice.

Social media comments specifically blamed large organisations and the industry. There were specific personal and sometimes derogatory comments towards professionals featured in the television broadcast.

Conclusions: The study provides a valuable insight in to the public anxiety about the use of mesh, with a distrust of organisations and professionals. There is a need for more clarity and transparency from everyone involved in the care of these women. There is a need for more specific and easily accessible information from professional and public organisations.

Reference:

  • http://www.bbc.co.uk/programmes/b006t14n - Current affairs programme, featuring interviews and investigative reports on a wide variety of subjects

Disclosure:

Work supported by industry: no.

062

The preferred mode of delivery of medical professionals and non-professional mothers-to-be and the impact of additional information on their decision. A prospective, online-based, informative survey

Bihler, J 1 ; Tunn, R 2 ; Reisenauer, C 1 ; Kolenic, G 3 ; Pauluschke-Froehlich, J 1 ; Wagner, P 1 ; Abele, H 1 ; Rall, K 1 ; Naumann, G 4 ; Wallwiener, S 5 ; Wallwiener, M 5 ; Brucker, S 1 ; Huebner, M 6

1: Department of Womenʼs Health, University Hospital of Tuebingen, Germany; 2: Department of Urogynecology, German Pelvic Floor Centre, St. Hedwig Hospital, Berlin, Germany; 3: Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, USA; 4: Department of Gynecology and Obstetrics, Helios Hospital Erfurt, Erfurt, Germany; 5: Department of Gynecology and Obstetrics, University Hospital of Heidelberg, Germany; 6: Women´s Center Bern, Lindenhofgruppe, Bern, Switzerland

Introduction: The prevalence of pelvic floor disorders significantly correlates with parity and mode of delivery.(1) Over the last decades, unsatisfactory rates of C-sections have led to an increased interest in the personal attitude regarding the mode of delivery. Apart from obvious indications for C-sections, the grey area of relative indications might be influenced substantially by personal preferences.

Objective: The objective was to evaluate the personal preference of mode of delivery and to analyze differences in both medical professionals and non-professionals. In addition, the possible interest in participating in not yet established prevention measures was evaluated. Furthermore, we hypothesized, that gaining information about the system of risk stratification provided in the survey could potentially change participants´ decision regarding the preferred mode of delivery, therefore subjects were asked twice (before and after providing information).

Methods: This is the main analysis including the preliminary results published earlier. During the last year four professional cohorts (all participants of the National Urogynecology Congress, all employees of two major University Hospitals, and all members of the National Society of Gynecology and Obstetrics) were invited online. The two non-professional groups included pregnant women who sought for medical care either at our University Hospital or at their general OB/GYN practitioners in the local area. Since no validated questionnaires were available, an online questionnaire was developed for this study. Approval was given by the local ethical committee. The Study is registered at clinicaltrials.gov.

Results: In summary a total of n=2,324 medical professionals (MP) and 269 non-professional mothers-to-be (NP) participated. Vaginal delivery (VD) was the preferred mode of delivery in both groups (MP 90.6% vs. NP 88.8%; p=.429). Main reasons for participants opting for C-Section (CS) were analyzed: MP are more likely to opt for CS due to concerns regarding unspecified pelvic floor disorders (MP 56% vs. NP 9% p <.001), or specifically urinary incontinence (MP 65.4% vs. NP 13.6%, p <.001), fecal incontinence (MP 57% vs. NP 13%, p <.001) and prolapse (MP 59.6% vs. NP 13.6% p <.001). Likewise, parity and a prior experienced C-section (pCS) had a significant impact on the decision towards vaginal delivery. (parity MP OR 7.52 95%CI 4.6-12.3, NP OR 9.3 95%CI 1.9-44.2; (pCS) MP OR .121 95%CI .07-.19, NP OR .053 95%CI .01-.25). Moreover, provided information about prevention measures, such as a risk stratification system, did not change participants´ minds regarding their preferred mode of delivery (MP p=.137, NP p= .245). In the group of non-professionals, 81% expressed their confidence in knowing about the pros and cons of CS and VD (Yes 81.0%; No 9.7%; unsure 9.3%).

Conclusions: Both MP and NP mothers-to-be prefer vaginal birth. However, within the group that opted for CS, MP were significantly more often concerned of pelvic floor disorders compared to NP. Although the NP felt confident in knowing the advantages and disadvantages of either mode of delivery, the awareness of pelvic floor disorders is different. Likewise, prevention measures as risk stratification systems, would be more favored by MP. Future prevention aspects might include education in pelvic floor matters.

Table 1: The participants´ interest regarding not yet established prevention measures to avoid pelvic floor disorders

  MP   NP   
n % n % p
Willingness to participate in a risk stratification system
Yes
No
unsure
1638
327
359
70.5
14.1
15.4
148
61
60
55.0
22.7
22.3
0.000*
Interest in a pessary therapy to support postpartum recovery
Yes
No
unsure
1012
714
598
43.5
30.7
25.7
98
86
85
36.4
32.0
31.6
0.047*

VD = vaginal delivery; CS = caesarean section MP = medical professionals; NP = non-professional mothers-to-be; * shows statistical significance

References:

1.Borello-France D, Burgio KL, Richter HE, Zyczynski H, Fitzgerald MP, Whitehead W, et al. Fecal and urinary incontinence in primiparous women. Obstet Gynecol. 2006;108(4):863-72.

Disclosure:

Work supported by industry: no.

063

Position, where and how? Does delivery position, place and mode of delivery affect the risk of Obstetric Anal Sphincter Injuries (OASIS)

Da Silva, AS 1 ; Thiagamoorthy, G 1 ; Flint, R 1 ; Rajshekhar, S 1 ; Srikrishna, S 1 ; Robinson, D 1 ; Cardozo, L 1

1: King's College Hospital

Introduction: Obstetric Anal Sphincter Injuries (OASIS) can lead to significant co-morbidities such as incontinence, pain and rectovaginal fistula formation. Maternal, infant and delivery factors have been shown to vary the incidence of OASIS such as race, malpresentation, infant birth weight and instrumental use1. A study of 814 women identified the standing position increases the risk of OASIS 7-fold with few other studies available for comparison2.

Objectives: Identify if mode of delivery, place of birth and delivery position affect the risk of OASIS

Methods: Contemporaneously recorded antenatal and intrapartum records were studied from live vaginal deliveries between 2007 and 2016 at our obstetrician led unit. Data were statistically analysed for the association between OASIS with delivery risk factors for odds ratios obtained by multinomial logistic regression using IBM SPSS (Version 24).

Results: Datasets of 48,798 live births were analysed. The rate of spontaneous vaginal deliveries was 29,114 (59.6%) and assisted vaginal deliveries 6918 (14.2%). The overall incidence of OASIS was 3.5%, of these, 75.7% occurred in primiparous women compared to 23.3% in multiparous women (P<0.001, CI 2.732-4.410). Figure 1 presents a forest plot of the risk of sustaining OASIS between position, place and mode of delivery.

Conclusion: This is the largest UK cohort of consecutive women analysed for OASIS. The overall incidence of OASIS is similar to the national average, with 2.9% occurring on labour ward (LW) versus 3.7% in the midwifery-led unit (MLU). Injury rates were lowest in the homebirth setting (1.3%), however the proportion of primiparous women was significantly lower in this group (34.1%) compared to LW (48.5%) and the MLU (50.1%) (P<0.001). When adjusted for parity the incidence of OASIS in primiparous women was 3.6%, 4.5% and 5.9% in homebirth, LW and MLU respectively. The incidence of OASIS is increased with instrumental deliveries; 2.7% non-instrumental vs 7.0% instrumental deliveries, (P<0.001, CI 0.337-0.425). Semi-recumbent and kneeling positions marginally reduces the risk of OASIS. Notably, delivery on the Birthing-Stool triples the risk of OASIS to 12.0% and mothers should be counselled about this (P<0.001, CI 1.570-6.559).

figureac

Figure 1. Forest plot showing odds ratio for OASIS based on delivery risk factors

REFERENCES: 1. RCOG. GTG No. 29. 2. Acta Obstet Gynecol Scand 1994;73:630–3.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (DC - Astellas allergan cogenetix ferrying ixaltis Boston. LC - Astellas Boston).

064

Postpartum urinary and anal incontinence in women with and without obstetric anal sphincter injuries

Ros, C 1 ; Anglès, S 1 ; Elias, N 1 ; Espuña, M 1

1: Hospital Clinic de Barcelona

Introduction: Obstetric anal sphincter injuries (OASIS) are the main factor to have anal incontinence (AI) in young women. However, the relationship between OASIS and urinary incontinence (UI) remains controversial1.

Objective: To compare symptoms of UI and AI between women with and without history of OASIS, at 6 months postpartum, according to the mode of delivery.

Methods: A study including women with history of primary repaired OASIS in a tertiary university hospital from 2012 to 2107 were designed. A group of women without OASIS were selected as the control group, with normal and instrumental deliveries (Naegele and Kjelland forceps, Spatules Thierry and ventouse). All patients filled out the International Consultation on Incontinence Questionnaire (ICIQ-UI-SF) to detect symptoms of UI (score 0-21), and the Wexner questionnaire to detect symptoms of AI (score 0-20), at 6 months postpartum. A 3D-endoanal ultrasound (EAUS) was performed to all women with OASIS (probe 2052, Ultraview800, BK-Medical), and the residual defect was classified according to Starck system2 (0-16).

Results: A total of 330 women were included: 140 patients with OASIS and 190 without OASIS. Up to 85.8% of women were primiparous. No statistically significant differences (NS) were found between patients with and without OASIS considering age (mean 33.4±5.1 years old) or gestational age (40.0±1.3 weeks), whereas neonatal weight was higher among patients with OASIS (3431±414 g vs 3316±429 g; p<0.01) and the episiotomy rate was lower (44.6% vs 69%; p<0.001).

Up to 43/190 (23%) women expressed symptoms of stress UI and 27/190 (14%) of urge UI in the control group, while 40/140 (29%) and 14/140 (10%) did in the OASIS group, respectively (NS). No statistically significant differences were found in symptoms severity measured by the ICIQ-UI-SF score, comparing women with and without OASIS, neither analysing the results according to the mode of delivery (normal and instrumental delivery) (Table 1).

Flatus incontinence was referred by 54% of all women included in this study (65% with OASIS vs 45.8% without OASIS; p=0.001). Up to 22% of all patients explained liquid incontinence (17.8% OASIS vs 7.9% without OASIS; p<0.05), and 6%, solid incontinence (11.4% OASIS vs 0.5% without OASIS; p=0.04). Finally, up to 22% of women with OASIS complaint of urgency, while 11.6% of women without OASIS. As expected, women with OASIS obtained higher Wexner scores than women without OASIS (Table 1). A positive correlation was found between Wexner and Starck score measured by EAUS (p=0.01).

Conclusions: One in four of patients included in this study had symptoms of stress UI and one in eight, symptoms of urge UI at 6 months postpartum. The proportion of women with UI symptoms was similar in women with and without OASIS. No differences on ICIQ-UI-SF score between women with a normal vaginal delivery and women with instrumental deliveries. More than a half of patients referred AI, especially flatus incontinence. Women with history of OASIS expressed more symptoms of AI.

Table 1. Results of ICIQ-UI-SF and Wexner comparing women with and without OASIS, and according to the mode of delivery.

  Without OASIS (n=190) With OASIS (n=140) p
ICIQ-UI-SF score 2.6±4.1 2.6±4.5 NS
 Normal 2.8±3.9 2.6±4.5 NS
 Instrumental 2.6±4.3 2.6±4.5 NS
SUI symptoms N(%) 43/190 (22.6) 40/140 (28.6) NS
UUI symptoms N(%) 27/190 (14.2) 14/140 (10) NS
Wexner score 1.1±1.6 2.7±3.2 0.001
 Normal 1.2±1.8 2.5±3.3 0.02
 Instrumental 1.1±1.6 2.9±3.2 0.001
Wexner>0 N(%) 87/190 (45.8) 94/140 (67) 0.04
  NORMAL (n=104) INSTRUMENTAL (n=217)  
ICIQ-UI-SF score 2.7±4.2 2.6±4.3 NS
Wexner score 1.9±2.9 1.7±2.5 NS
Wexner>0 N(%) 62/104 (59.6) 116/217 (53.5) NS

References:1Int Urogynecol J Pelvic Floor Dysfunct. 2008;19:179-83; 2Eur J Obstet Gynecol Reprod Biol. 2007 Feb;130(2):193-201.

Disclosure:

Work supported by industry: no.

065

Is EpiNo Birth Trainer an effective tool to reduce pelvic floor injury among primiparous women? First Italian prospective randomized-controlled single-blind ongoing Study

Pifarotti, P 1 ; Dell'Utri, C 1 ; Bonfanti, I 1 ; Masserini, F 1 ; Scaramella, E 1 ; Buonaguidi, A 1

1: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Introduction: WHO recommends a restricted use of episiotomy and suggests taking high degree perineal tears as quality indicators. Therefore, the need to research and develop new preventive strategies. EpiNo Birth Trainer (Tecsana GMBH) is composed of a soft inflatable balloon that progressively strengthens and stretches the muscles, with the intent to facilitate a natural birth and reduce the risk of perineal injuries.

figuread

Objective: To evaluate the efficacy of EpiNo on pelvic floor injuries among primiparous women enrolled in a tertiary obstetric unit, where the recorded episiotomy rate performed is 80%.

Methods: Between January and August 2017, 104 Caucasian primiparous women with singleton uncomplicated pregnancies, age >18 year and a Body Mass Index <30 have been recruited, in a Maternity Centre of reference, which welcomes over 6.000 babies a year. 132 was the calculated sample of patients needed. A computer generated the randomization list. Midwives and Obstetrician were blinded to group allocation. Participants underwent antenatal urogynaecological assessment, which included the evaluation of the pubococcygeus muscle activity (PC test). Prenatal patients’ perception of pelvic floor disorders has been investigated by means of standardized Questionnaires. Women who received EpiNo, were coached to use it 15 minutes daily, from the 36th gestational week onwards. Perineum was considered intact, if no suturing was required. Follow up was at 4, 6 ,12 months.

Results: Of the 98 women initially included,18(18%) underwent a Caesarean Section (CS) and has been therefore excluded. Out of the 80 women remaining, 37(46%) received Epi No and 43 (54%) were in the control Group. The thorough episiotomy rate was 65% in both groups. The investigated obstetrical outcomes did not statistically differ in the two groups. Although a clinical benefit in the Epi No group has been observed, since a higher rate of intact perineum has been recorded (78 vs 67%), as well as a lower rate of minor (22 vs 30%) and major (0 vs 2%) perineal tears respectively. We observed a significantly shorter 2nd stage of labour in EpiNo users (37 vs 53 minutes, p = 0.03). EpiNo did not influence Fetal outcome and APGAR score. 35(44%) women were available for follow up 4 months postpartum, of them 19(51%) cases and 16(37%) controls. At the follow up visit EpiNo users had a lower rate of pubococcygeus muscle strength Impairment, measured by PC test compared to the controls (68 vs 81%), moreover a higher rate of sexual activity has been recorded (50 vs 31%). Urinary incontinence and anal incontinence episodes did not differ in the two groups.

Conclusions: EpiNo is a safe medical device, well tolerated from women and their partners. Moreover, it increases patients confidence with their body, reduce birth anxiety and have a positive psychological impact, able to shorten the second stage of labour, as shown in our preliminary data. We believe in the beneficial effect of EpiNo on the preservation of an intact perineum and to reduce pelvic floor impairments. Although a long-term follow-up is needed.

References:

  1. 1.

    Int Urogynecol J. 2013

  2. 2.

    Cochrane Database Syst Rev. 2017

Disclosure:

Work supported by industry: yes, by Tecsana GmbH.

066

Natural history of asymptomatic POP recurrence: What happens next? What should I advice my patient?

Alarcon , MG 1 ; Mass-Lindenbaum M, M 2 ; Pizarro - Berdichevsky, J 3

1: Potificia Universidad Católica de Chile ; 2: Universidad de los Andes - Chile; 3: Pontifica Universidad Catolica de Chile

Background: During physical examination, after Pelvic Organ Prolapse (POP) Surgery, it is not uncommon to identify descent of any compartment at hymen in asymptomatic patients. Identifying which patients will develop progression or will complain of symptoms could be relevant for counseling and eventually planning prevention strategies.

Objective: The aim is to describe the natural history of these patients, analyzing anatomical progression below the hymen (Ba or Bp or C points at +1 or more) and/or bulge symptom development. The secondary aim is to identify risk factors for progression or to develop symptoms of POP.

Materials and Methods: A retrospective analysis from 2008-2017 from a prospectively collected database was performed. Postoperatively, our patients are reassessed 4 weeks, 3, 6, and then yearly. The follow up includes Pelvic Organ Prolapse Quantification System(POP-Q) every 6 months.

Inclusion criteria: 1) Any POP surgery, 2) Ba or Bp at hymen(0) or C descent more than half TVL, 3) absence of symptoms at the time of POP-Q defined previously. 4) to have at least 1 POP-Q after the asymptomatic recurrence identified with a difference of at least 6 months. The primary outcome was a composite POP progression (bulge sensation or Ba, Bp or C at +1 or more). Logistic regression analysis was performed for the composite outcome. The results are presented as means±standard deviations, or counts (percentages).

Results: Between 2008 and 2017, 163 operated patients had asymptomatic POP recurrence. The mean age was 58±9. 122(77.2%) were postmenopausal. Parity was 3±2. 53(32.5%) had at least 1 forceps. Average follow up was 35.2 ±21 months. Index POP surgeries were: Sacrocolpopexy 49(30.1%), Colpocleisis 1(0.6%), Colporrhaphy Repair 117(71.8%) Vaginal Apical Suspension 75(46%). Concomitant surgeries were Hysterectomy(vaginal or supracervical) on 108(66.3%) and Sling(TVT or TOT) on 91(55.8%).

During follow up, 79 patients, (48%) persisted asymptomatic. 84(52%) met the criteria for the composite outcome. 45(53%) became symptomatic and 72(44.2%) had POP progression below the hymen. 7(8.3%) were reoperated. Anatomical recurrence at any point of POP-Q was developed at 23±17 months and prolapse symptoms appeared at 29±19 months. In logistic regression analysis, the only variable that persisted as significant to predict the composite outcome was older age with an OR 1.047 CI 95% 1.010-1.085 (56 vs 60 years).

Conclusions: In this study 52% of patients had a possible clinically significant progression or symptom development during follow up. This information could be relevant to counsel patients with asymptomatic recurrence. This may be associated with older age of patients which could be in a higher risk subgroup. However, these results should be interpreted with caution due to the retrospective nature of the study.

Disclosure:

Work supported by industry: no.

067

Overview about diagnostic options in physiotherapy for patients with pelvic organ prolaps

Soeder, S 1

1: German Pelvic Floor Center

Introduction: There are many women different age with a pelvic organ prolapse in different stages and symptoms. The Quality of Life is often minimised and the women are changing her lifestyle, stopping sport activities or isolating themselves from social events. The guidelines recommend an adäquat diagnostic, a conservative treatment with physiotherapy and /or surgery. Pelvic organ prolapse includes all pelvic organs. They can have an incontinence, but not necessarily. This overview is looking for the diagnostic parameters and pelvic pain, surgery and strengthening.

Objectives: A) Are there parameters that can assess the outcome of a physiothereutic treatment of an pelvic organ prolapse before and after surgery? B) Wich common features of these dysfunctions have been already investigated in intervention studies?

Methods: A literature research was done including studies from 2008 – 2016 in the Cochrane database, the database of IUGA and ICS. The keywords has been identified with the complications and symptoms of the AWMF interdisciplinary guidelines of pelvic organ prolapse from 2016. The following 4 groups were created: Symptoms( Pelvic pain, tenderness, urinary incontinence, Urge, de novo urge, cystocee, Pelvic floor dysfunction, POP, Triggerpoints, SUI, Dyspareunia, sexual function, visceral pain), Diagnostik (Oxford, PERFECT, Ultrasound, Rehabilitativer ultrasound, Biofeedback, EMG, Digital examination, Palpation, elasticity, perineometer, dynamic MRI, WQuestionaire), Therapie conservative: (Pelvic floor training, pelvic muscle training, electrical stimulation, biofeedback, pessary, pelvic floor exercises, physiotherapy, behavior training), Surgery ( TVT, MESH, Sling, surgery, Mesh revision, mesh related complications, mesh excision)

Results: The literature research showed 5 Retrospective studies, 10 Reviews, 7 RCT, 2 comparative studies, 1 clinical opinion, 3 qualitative analysis, 1 Pilotstudy, 3 prospective studies.

Those studies have been classified in 4 different groups:

  1. 1.

    Assessments of Pelvic Floor Measurements: 4 studies

  2. 2.

    Chronic Pelvic Pain Syndroms: 7 studies

  3. 3.

    Pelvic Floor Strengthening: 13 studies

  4. 4.

    Surgery: 8 studies

Conclusion: Back to the objectives Group No 1 shows a large selection of assessments of pelvic Floor measurements and also validated measurements. Also Group No 2 shows an overview and the complexity of pelvic pain, triggerpoints, questionaires. Group No 3 proofs the effectiveness of diagnostic parameters of pelvic floor muscles, the individual training, the influence of quality of life in terms of treatment decision, group No 4 shows the positive outcome of surgery, but also the complications. After this intensive confrontation with literature and 4 different views to the objectives, the questions A and B are positive described and investigated. As in the guidelines is written the individual diagnostic is the main point to the right treatment. The 4 Groups give us good base of possibilities.

Literature:

  1. 1.

    AWMF Guideline Diagnostic and therapy of female descensus genitalis, German Society of Gynecology and Obstretics, in cooperation with Swiss and Austrian society for Gynecology and Obstretics, 2016.

  2. 2.

    Kavvadias T, Baessler K, Schuessler B; Int Urogynecol J (2011) 22:385-393; pelvic pain in urogynecology. Part I: evaluation, definitions and diagnosis.

  3. 3.

    Kavvadias T, Baessler K, Schuessler B; Int Urogynecol J (2012) 22:385-393; pelvic pain in urogynecology. Part II: ttreatment options in patients with lower urinary tract symtoms.

Disclosure:

Work supported by industry: no.

068

Surgical treatment of primary apical prolapse: A comparison of different vaginal surgical techniques

Husby, KR 1 ; Larsen, MD 2 ; Lose, G 1 ; Klarskov, N 1

1: Department of Obstetrics and Gynecology, Herlev and Gentofte University Hospital; 2: Center for Clinical Epidemiology, Odense University Hospital, and Research Unit of Clinical Epidemiology, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.

Introduction: Uterus prolapse is a common diagnosis affecting the quality of life for millions of women worldwide. Today no consensus exists on which operation technique is ideal to treat apical prolapse. Various surgical techniques are being performed with the vaginal hysterectomy with suspension of the vaginal cuff as the most frequently used. The popularity of uterus-preserving techniques is increasing. Until now no study has compared the different vaginal techniques in one study.

Objective: The aim of this study was to compare the efficiency of different vaginal operation types to treat primary apical prolapse, evaluated on risk of relapse surgery.

Methods: Data was obtained from the Danish National Patient Registry (NPR) which contains all operations performed in Denmark. Patients operated in the apical compartment in Denmark 2010-2016 (both inclusive) were included and with follow-up until June 30 2017. The NPR was supplemented with clinical collected data from the Danish Urogynecological Database. Patients who previously were hysterectomized or operated for prolapse in the apical compartment were excluded. Data was analysed using a Cox proportional hazard regression analyse and adjusted for age, preoperative prolapse stage, ASA-score, smoking, BMI and use of alcohol.

Results: The Hazard ratio for relapse operation in one compartment was 1.12 for vaginal hysterectomy, 4.40 for sacrospinous ligament fixation, and 1.89 for vaginal uterus-preserving operations with mesh kits compared to the Manchester-Fothergill procedure (table 1). Thus the Manchester-Fothergill procedure is the operation with fewest reoperations due to recurrence. 40% of the patients had a reoperation due to pelvic organ prolapse recurrence within 7 years after a sacrospinous ligament fixation (fig. 1).

Conclusions: The sacrospinous ligament fixation has an alarmingly high number of reoperations due to prolapse recurrence. The Manchester-Fothergill procedure seems to be the procedure with fewest reoperations due to recurrence, and is the significantly best uterus-preserving operation.

Table 1 N Hazard Ratio [95% CI] Hazard Ratio adjusted [95% CI]
Manchester-Fothergill procedure 1,323 1 1
Vaginal hysterectomy with suspension of vaginal cuff 1,742 1.12 [0.87-1.44] 1.11 [0.86-1.43]
Sacrospinous ligament fixation 769 4.40 [3.45-5.64]* 4.52 [3.47-5.89]*
Vaginal uterus-preserving operation with mesh 98 1.89 [1.08-3.07]* 1.93 [1.10-3.40]*

* Significantly more reoperations than patients operated with the Manchester-Fothergill procedure

Fig 1.

figureae

Disclosure:

Work supported by industry: no.

069

Should a speculum examination be routine practice at pessary changes?

Davis, C 1 ; Orako, R 1 ; Rantell, A 1 ; Robinson, D 1 ; Cardozo, L 1

1: Kings College Hospital

Introduction: Pessaries can be a very effective way to conservatively manage pelvic organ prolapse (POP). However, pessary use can occasionally result in tissue damage and excoriation or ulceration. Signs of tissue damage include bleeding, abnormal discharge and pain [1]. To assess for tissue damage a speculum examination is carried out. Currently there is a lack of guidance whether to perform a speculum examination as part of a routine assessment when changing pessaries.

Objective: To assess the need for speculum examination on all patients at routine pessary changes

Methods: A retrospective analysis of 75 women attending a tertiary urogynaecology unit’s nurse-led pessary clinic. All underwent a Cusco’s speculum examination as part of their routine change. Data were collected and analysed. We assessed bleeding both prior to and at the time of change of pessary, abnormal discharge, pain, the use of topical oestrogens (Ovestin cream or Vagifem pessaries) and the length of time between changes.

Results: 20% of patients seen had excoriation on speculum examination. 53% of these patients had a ring insitu, 46% had a gellhorn. 46% of patients with excoriation in the vagina had abnormal discharge, 33% had bleeding and 6% presented with both. 27% were asymptomatic. 33% had their pessary insitu longer than we routinely advise. Interestingly of the patients with excoriation 60% reported they were using topical oestrogens.

Conclusions: From our results we have demonstrated the need to perform a speculum examination at each change of pessary. Of the patients who had excoriation 27% were asymptomatic and therefore would be missed. This could have greater health consequences such as incarcerated pessary, increasing pain on future changes and the possibility of erosion through the vault. Contrary to anecdotal evidence, topical oestrogens may not safeguard vaginal tissues.

  1. 1.

    Hooper, G. L., Atnip, S. and O'Dell, K. (2017), Optimal Pessary Care: A Modified Delphi Consensus Study. Journal of Midwifery & Women's Health, 62: 452–462. doi:10.1111/jm. wh.12624

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Allerga, Pfizer, Ferring, Astellas, Congetix, Coloplast, Mediplus, Bard).

070

Sacrospinous ligament fixation and post-operative pain

Brighton, A1; Hayward, L1

1: Middlemore Hospital, Auckland, New Zealand

Introduction: Sacrospinous Ligament fixation (SLF) is a procedure used to treat apical prolapse. It involves the placement of either permanent or absorbable sutures, from the vaginal vault or cervix into the sacrospinous ligament, which runs from the ischial spine medially to the sacrum. A commonly recognized complication of this procedure is buttock pain, which is thought to result from bruising or damage to the nerves originating from the S3 and S4 nerve roots [1]. Studies vary in the reported incidence of this pain, and time to resolution [2, 3]

Objective: To investigate the incidence and nature of post-operative buttock pain and the speed of resolution in women undergoing SLF for apical prolapse.

Methods: Prospective observational study of 40 women undergoing SLF for apical prolapse greater than stage 2 on POP-Q examination, either alone or with a concomitant procedure, between October 2014 and March 2016. Patients completed a pre-operative questionnaire and post-operative questionnaire on day 1, and then weekly questionnaires for 6 weeks. Patients rated their pain using a Likert scale and marked its position on an anatomical diagram. Data on analgesia usage and side effects were collected.

Results: Data analysis was performed for 38 patients; 2 patients were excluded due to missing data. 37/38 had a unilateral right sided SLF and 1/38 had bilateral SLFs. Concomitant procedures included anterior repair (33/38, 86.8%), posterior repair (21/38, 55.3%), transvaginal tape (TVT) (4/38, 10.5%), labioplasty (1/38, 2.6%) and anal skin tag removal (1/38, 2.6%). Nine patients (23.7%) reported pre-operative pain, with an average pain score of 5. The incidence of immediate post-operative buttock pain was 60.5%, with 50% of patients reporting a maximal pain level of severity 6 or more. Pain scores decreased over time (figure 1). Only three patients (10.7%) reported any pain at 6 weeks, with pain scores of 1 or 2.

25 different analgesia combinations were used to treat pain. 36/38 (94.8%) were prescribed paracetamol, 20/38 (54.1%) gabapentin, 13/38 (34.2%) ibuprofen and 2/38 (5.3%) diclofenac. 30/38 (79%) women received some form of opiate analgesia. Medication side effects were reported. 28/38 (73.9%) complained of constipation. Tiredness and nausea were each reported in 13/38 (34.2%) women.

Conclusions: The incidence of buttock pain after SLF is high, but the duration is short, and complete resolution usual by 6 weeks. No patient had a true neuralgia and pain was more likely secondary to bruising. This information can be used to better council patients pre-operatively.

figureaf

Figure 1 - Average weekly pain scores

1.Lazarou, G., et al., Anatomic variations of the pelvic floor nerves adjacent to the sacrospinous ligament: a female cadaver study. Int Urogynecol J Pelvic Floor Dysfunct, 2008. 19(5): p. 649-54.

2.Souviat, C., et al., Long-term functional stability of sacrospinous ligament-fixation repair of pelvic organ prolapse. J Obstet Gynaecol, 2012. 32(8): p. 781-5.

3.Unger, C.A. and M.D. Walters, Gluteal and posterior thigh pain in the postoperative period and the need for intervention after sacrospinous ligament colpopexy. Female Pelvic Med Reconstr Surg, 2014. 20(4): p. 208-11.

Disclosure:

Work supported by industry: no.

071

Deep learning for automatic analysis of the puborectalis muscle and urogenital hiatus on transperineal ultrasound

van den Noort, F 1 ; Grob, AT 1 ; Slump, CH 1 ; van der Vaart, CH 2 ; van Stralen, M 3

1: University of Twente; 2: University Medical Center Utrecht; 3: University Medical Center Utrecht

Introduction: The quantitative analysis of transperineal ultrasound (TPUS) is currently done manually, measuring hiatal dimensions, echo intensity or global strain. This is observer dependent and time consuming. Deep learning mimics learning of the human brain by optimizing a convolutional neural network (CNN). It has recently become the state-of-the-art technique for medical image segmentation tasks.

Objective: Automating the quantitative analysis of TPUS images, using deep learning.

Methods: The puborectalis muscle (PRM) and the urogenital hiatus (UH) were manually segmented in 1318 TPU images with minimal hiatal dimensions. This data is from 253 women in their first pregnancy at 12 and 36 weeks pregnancy in which the PRM and UH were delineated manually in rest, contraction and Valsalva. We randomly split the data set into a training (122 women, 649 images) and test (131 women, 669 images) set. Using the training set, we trained an 11-layered convolutional neural network (CNN) for automatic segmentation of the PRM and UH. This network was optimized by evaluating its performance on the validation set (64 images from the test set). The resulting CNN was then independently evaluated on the remaining images in the test set (605 images). We calculated the hiatal dimensions and the echo intensity and length of the PRM from these segmentations. We evaluated the performance of our system by calculating the means (μ), standard deviations (sd) and intraclass correlation coefficients (ICCs) with their 95 % confidence intervals (CI) for these variables as compared to manual segmentations performed by the human observer.

Results: An example of the segmentation performed by the CNN is shown in Figure 1. The ICC between CNN and manual segmentation are summarized in Table 1. There was a good agreement on the UH width and PRM length and an excellent agreement on the other parameters.

Table 1: The μ(sd) and ICC(CI) of the UH dimensions and the length and intensity of the PRM.

  Manual μ (sd) CNN μ (sd) ICC (CI)
Width UH 4.2 (0.5) cm 4.1 (0.5) cm .78 (.66-.84)
Length UH 5.0 (0.9) cm 4.9 (0.9) cm .96 (.94-.97)
Area UH 14.9 (4.1) cm2 14.7 (3.9) cm2 .96 (.95-.96)
Intensity PRM 138 (22) 141 (21) .94 (.88-.97)
Length PRM 12.2 (1.8) cm 11.5 (1.8) cm .72 (.53-.82)
figureag

Figure 1: Example of CNN segmentation (PRM (blue), hiatus (green)), compared to manual segmentation and the original image.

Conclusion: We showed that deep learning (CNN) can be reliably used for quantitative analysis of TPUS images with intact PRM. In future work, we will extend this research by applying this method also to avulsion patients to be able to automatically analyze all female TPUS data for diagnosis and treatment guidance.

Disclosure:

Work supported by industry: yes, by Philips and TomTec.

072

Impact of vaginal douching products on growth of vaginal commensal Lactobacillus and E. coli

Hesham, H 1 ; Hung, K 1 ; Bergerat-Thompson, A 2 ; Weinstein, M 1 ; Mitchell, C 2

1: Massachusetts General Hospital; 2: Vincent Center for Reproductive Biology, Massachusetts General Hospital

Introduction: Close to 20% of American women use vaginal douching products to address symptoms of odor, discharge and discomfort. Douching is associated with an increased risk for bacterial vaginosis, but few studies have assessed the impact of douching on risk for urinary tract infection (UTI).

Objective: The aim of this study was to evaluate the effect of commonly used commercial vaginal douching products on the vaginal microbiota including the uropathogen Escherichia coli (E. coli) and the four most common vaginal commensal Lactobacillus species.

Methods: Five species of bacteria were grown in broth: E. coli, Lactobacillus crispatus, L. jensenii, L. gasseri, L. iners. The bacterial broth cultures were exposed to varying concentrations of commonly used commercial douching products containing iodine, baking soda, or vinegar. Saline solution was used to dilute douching products and as a control. Change in optical density (OD600) was measured over 24 hrs for lactobacilli and 2 hours for E. coli to assess growth. OD600 was compared across concentrations for each product using ANOVA.

Results: The baking soda douche strongly inhibited growth of both E. coli and all four lactobacilli, with a dose response seen for the lactobacilli (* = p < 0.01) (Figure 1). However, at the highest concentrations iodine and vinegar based douching solutions inhibited E. coli growth (* = p < 0.01) but not lactobacilli (Figure 2).

figureah

Conclusion: Inhibition of lactobacilli by baking soda based douches could predispose women to more UTI, despite concurrent inhibition of E. coli. Iodine and vinegar based douches do not inhibit protective vaginal Lactobacillus species in vitro.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Symbiomix Therapeutics, LLC).

073

A histological basis for the nonlinear behavior of pelvic tissues

Rynkevic, R 1 ; Ferreira, J 1 ; Martins, P 1 ; Parente, M 1 ; Mascarenhas , T 2 ; Fernandes, AA 1

1: INEGI, University of Porto, Faculty of Engineering, Portugal; 2: Department of Gynecology and Obstetrics, Centro Hospitalar de São João-EPE, Faculty of Medicine, University of Port, Portugal

Introduction: In the last few years there has been a growing interest in the characterization of the mechanical behavior of human soft tissues, in the biomechanics community [1]. Mechanical characterization of living tissues and computer-based simulations related to medical issues, have become increasingly important to improve diagnostic processes and treatments evaluation [2]. This study links experimental and computational analysis of living tissues using ex vivo, in vitro, and in silico techniques.

Objective: The goal of this work is to go through each of the steps involved in the mechanical characterization of biological soft tissues and to explore the link between experimental and computational analysis. The general approach is based on the use of curve fitting algorithms that allow the determination of the material-dependent parameters from experimental data, and ultimately predict the tissues mechanical behavior through numerical simulation.

Methods: The vaginal tissue, bladder, and rectum of virgin and pregnant Swifter ewes (n=5 per group) were collected. Uniaxial tensile tests were performed to obtain mechanical properties of the tissues, using nonlinear constitutive models of fibre-reinforced hyperelastic materials. A Simple Genetic Algorithm (SGA) is employed for the curve-fitting of the resultant stretch-stress curves:

\( \psi ={C}_{10}\left({I}_1-3\right)+\frac{k_1}{2{k}_2}\left({e}^{k_2{\left({I}_4-1\right)}^2}-1\right) \) (1)

For the histological analysis, samples were stained with Miller's Elastica to allow identification and quantification of collagen, elastin, and smooth muscle fraction.

Results: Biomechanical changes in pregnant sheep were observed. Vaginal tissue was more compliant, than of virgin sheep (39.8%; p<0.05). Pregnant sheep bladder became more rigid (74.6%; p<0.05), less extensible (21.2%; p<0.05) and thinner (20.2%; p<0.05). As for the rectal wall, Young’s moduli of comfort and stress zones were higher in pregnant sheep (61.9%, p<0.05; 44.1%, p<0.05), however, rectum became less elastic than of virgin (23.8%, p<0.05). Bladder of pregnant sheep contained more total collagen (34.6%; p<0.05), less elastin fibres (37.6%; p<0.05) and less smooth muscle cells (31.3%; p<0.05). The rectum contained more total collagen (24.6%; p<0.05), less elastin fibres (36.9%, p<0.05) and less smooth muscle cells (11.2%, p<0.05).

The obtained material parameters C10, k1 and k2 agree with the histological data (Figure 1). Soft tissues have shown nonlinear material parameters (coefficient k1), in accordance with higher collagen content while low collagen content is evidenced in softer material parameters.

Conclusions: In this study it was conducted a biomechanical and histological analysis of the sheep vaginal wall, bladder, and rectum. Curve-fitting algorithms were applied to experimental data. Experimental and simulation fittings are in good agreement with histological data. The material parameters obtained are ready to be used in complex simulation environments.

figureai

Figure 1. Graphical results of the fitting for vaginal tissue, bladder and rectum of virgin and pregnant ewes. The fitting function (crosses) is plotted against the experimental data points (solid line), with coefficient k1 values and total collagen amount.

References:

[1] Proceedings of the IEEE, Institute of Electrical and Electronics Engineers, 86 (3), 1998.

[2] Biomedical Engineering Letters, Vol. 6, Issue 3, pp 181–195, 2016.

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Work supported by industry: no.

074

Does flatus incontinence matter?

Cattani, L 1 ; Gillor, M 1 ; Eslick, G 1 ; Dietz, HP 1

1: University of Sydney

Introduction: Anal incontinence is the involuntary loss of flatus, mucus, liquid or solid stool. Among those components, flatus incontinence is the most common accidental bowel leakage in women, yet its impact on quality of life is unclear and might not be sufficiently appreciated in clinical practice (1).

Objectives: This study aimed to determine correlations between sonographically diagnosed anal sphincter trauma and bother of anal incontinence (2) on the one hand and the St. Mark’s Incontinence Score (SMIS) with and without flatus incontinence component, in order to determine whether its inclusion improves SMIS performance.

Methods: This is an observational, cross-sectional study of women attending a tertiary urogynaecological unit between May 2013 and November 2015. Baseline assessment included a standardized interview with SMIS and VAS assessment for bother (2) and physical examination with International Continence Society Pelvic Organ Prolapse Quantification (POP-Q) and translabial 4D pelvic floor ultrasound (TLUS). 4D TLUS scans were performed in all patients in the supine position after voiding, at rest, on pelvic floor contraction and Valsalva maneuvers. At least one volume was obtained covering the entire length of the external anal sphincter. (3) These volumes were later analyzed on a desktop PC, using 4D view software, with the reviewer blinded to all clinical data. Statistical analysis was performed using SAS software. Statistical analysis was performed using univariate, multivariate and R-squared analysis and student t-test. A p < 0.05 was considered statistically significant.

figureaj

Figure: Normal sphincter in asymptomatic woman (A) and sphincter defect in patient with flatus incontinence (B)

Results: During the inclusion period 1104 patients visited our unit. 44 patients were excluded for missing data and 9 for suboptimal quality of ultrasound volumes, leaving 1051. Mean age was 57 years (17 – 89) and mean current BMI was 29.1 kg/m2 (15.1 -60.4). Among study patients, the prevalence of any anal incontinence and flatus incontinence were 16.4% (172/1051) and 13.9% (146/1051) respectively. Presenting symptoms were stress and urge urinary incontinence in 72.4% (761/1051) and 73.2% (769/1051) respectively, and 54.2 % (570/1051) were symptomatic for pelvic organ prolapse. Significant external anal sphincter (EAS) trauma was detected in 9.8% (103/1051) of patients and was associated with flatus incontinence (p = 0.002). Including flatus incontinence in the SMIS score gave an R-squared of 87.8% for predicting patient bother, while omitting the flatus incontinence question from the SMIS gave an R-squared of 86.3% for predicting bother. This difference was statistically significant (p=0.04).

Conclusion: Flatus incontinence is associated with ultrasound findings of EAS trauma. Its inclusion in the SMIS significantly improves the performance of this score in predicting patient bother from anal incontinence.

References:

1.Am J Obstet Gynecol 2005;192(5):1637-42.

2.Tech Coloproctol 2016;20:123-128.

3.J Ultrasound Med 2018;37:263-280.

Disclosure:

Work supported by industry: no.

075

Evaluation of biodegradable polymer nanoscaffold meshes impregnanted with or without human Wharton's jelly stem cells for the treatment of Pelvic Organ Prolapse

Lin, HZ 1 ; Claudine, S 1 ; Ng, RK 1 ; Bongso, A 2 ; Fong, CY 2

1: NUHS; 2: NUS

Introduction: Pelvic Organ Prolapse is a major health issue in women and its surgical management with native tissue repair or mesh augmentationis fraught with failures and complications respectively1. The recent advances in the field of tissue engineering and stem cell biology offer potential for better outcome. The newer nanoscaffold meshes have the advantages of being bioresorbable and provide stem cell niches for impregnanted stem cells to function optimally2. Stem cells impregnanted into such meshes have the advantages of producing new collagen and elastin for the pelvic floor to prevent POP.

Our lab has produced and characterized human Wharton’s jelly stem cells (hWJSCs) from human umbilical cord. hWJSCs possess multipotency traits like the embryonic stem cells and the adult human bone marrow stem cells. In addition, hWJSCs have the advantage of hypoimmunogenicity, lack of tumorigenesis and safety. hWJSCs will work well in our study because it can proliferate easily and fresh cell numbers can be harvested in plenty from umbilical cords, which are usually discarded in the labour ward. Our lab hs also proven the ability of hWJSCs to attach, proliferate and differentiate efficiently in the stem cell niches of three dimensional matrices, particularly nanofibrous scaffolds.

Objective: This pilot project aims to generate preliminary in vivo data on the ability of the hWSJCs to integrate and populate with our novel polycaprolactone (PCL) and polyglycolic acid (PGA) combination mesh in the lysine oxidase-1-KO murine model. We plan to characterize and study the integration of hWJSCs and PCL/PGA nanoscaffold in a murine model.

Methods: Anaesthesized mice were divided into 4 groups. With n=3/group/time period. Group 1: sham surgery was performed. Group 2: Mice with transplanted commercial polypropylene mesh. Group 3: Mice with PCL/PGA nannoscaffold. Group 4: Mice with PCL/PGA nannoscaffold impregnated with hWJSCs. Mice were culled on D3 7 and 14. We evaluate the muscle regeneration, presence of GFP-tagged hwJSCs in host tissues at various time points, signs of inflammation of the tissue around the meshes.

Results: Mice in group 3 showed significantly more amounts of tissue regeneration with suggestions of neovascularization noted on D14. We also noted mesh erosion via the ventral surface of the mice in Group 2 which was not seen in any of the other groups. This is in keeping with the presentation of mesh erosion in vagina which we note clinically.

Conclusions: Our preliminary data shows notable more evidence of regeneration in the mice with the PCL/PGA mesh impregnated with hWJSCs compared to the others. We postulate that the electrowoven PCL/PGA mesh could be less immunogenic or inflammatory and allow the mice to retain the transplant without much rejection. The discovery of mesh erosion only in our polypropylene arm was surprisingly, however this should be viewed with caution until we performed the experiment in more mice and at longer time points for a sufficient enough comparision.

References

1. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997 Apr 89(4) 501-6

2. Developingn a pro-regenerative biomaterial scaffold microenvironment requires T helper 2 cells. Science 352, 366-370

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Work supported by industry: no.

076

A mobile surgical outreach model: Building capacity for fistula care in the Democratic Republic of Congo (DRC)

Raha, K 1 ; Keyser, L 2 ; McKinney, J 2 ; Mukwege, D 1

1: Panzi Hospital and Foundation; 2: Mama, LLC

Introduction: The DRC is a country characterized by weak maternal health indicators; the World Bank reports a fertility rate of 6 and maternal mortality ratio of 550.1 Despite efforts to improve obstetric care, many women lack access to sufficient perinatal care and suffer complications from childbirth, including genital fistula (GF).1 In DRC the incidence and prevalence of GF is unknown. The majority of the country’s 77 million people live in rural areas that are difficult to reach and significantly underdeveloped.2 Political instability, conflict and inadequate investment in health infrastructure contribute to this lack of data and of any national strategic policy for GF prevention and treatment.3 Panzi Hospital (PH) in eastern DRC has provided comprehensive treatment for women with GF since its establishment in 1999 as a tertiary care facility specializing in gynecologic surgery. In 2011 PH began surgical outreach to expand efforts for GF prevention and treatment.

Objective: The aim of this paper is to describe the PH Mobile Surgical Outreach (MSO) model of care delivery for women with GF and to present data highlighting the program’s scope and clinical impact in 2011-2017.

Methods: PH created the MSO program to deliver health services to women with GF living in remote areas in DRC, and reduce geographic and security barriers to treatment. The primary aim is to bring PH expertise to the patient, reducing the need for her to travel long distances and spend months away from her family and community. The MSO model facilitates reintegration by educating the community about GF and encouraging family involvement in patient care. Local staff at each facility participate in training, including surgical skills, peri-operative care and community sensitization. Each mobile team consists of two surgeons, one surgical assistant, one nurse, and one anesthetist. Outreach trips are organized annually or bi-annually for each site, depending on the volume of cases and available funding. Site selection occurs in a two-step process: (1) identification of accessible hospitals in strategic locations; (2) initial site visit and site readiness assessment. This study presents 2011-2017 MSO activities, including the program’s geographic scope, and patient and provider outcomes.

Results: The MSO team has worked with 43 clinic sites across 12 provinces. Since 2011, they have conducted 77 site visits and provided surgical care for 2,017 women. Table 1 indicates the number of surgeries conducted each year by province from 2011-2017. Table 2 provides a clinical snapshot of the case mix in 2017.

figureak
figureal

Conclusions: The MSO model aims to build capacity to address GF by improving accessibility to skilled medico-surgical care and enhancing community awareness. Training efforts serve to improve skills of local providers, strengthen the health workforce and offer scalable, sustainable solutions to prevention and treatment efforts. This research demonstrates feasibility and provides indicators of program successes. It is possible that such a model be adopted as a national strategy to address barriers to skilled GF care.

References

  1. 1.

    https://www.unicef.org/infobycountry/drcongo_statistics.html

  2. 2.

    http://www.worldbank.org/en/country/drc/overview

  3. 3.

    Onsrud M et al. Int J Gynaecol Obstet. 2011;114(1):10-14. doi:10.1016/j.ijgo.2011.01.018 [doi].

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Renovia, Inc).

077

Comparison of the female urine microbiome cultured from midstream urine and catheter urine samples

Duckett, J 1 ; Wildman, S 2 ; Curtiss, N 1

1: Medway Hospital; 2: University of Kent

Introduction: The female urine microbiome (FUM) and its impact on health and disease is a current area of research. There remains debate regarding the best urine samples to collect. Whilst patients are often less keen to undergo catheterisation this method of urine collection provides less potential for contamination from the vaginal microbiome than midstream urine samples (MSU). A small study has previously suggested than the catheter urine samples (CSU) are more similar to urine samples achieved by super public aspiration than MSU samples. However, different studies on the FUM performed with CSU and MSU samples appear to grow a similar profile of genera.

Objective: To compare the microbiota grown from CSU and MSU samples by an extended culture methodology from women with refractory overactive bladder (OAB).

Methods: 24 women were recruited and consented for inclusion. Inclusion criteria were that they suffered with symptoms of OAB but not stress incontinence and had tried at least two anticholinergic drugs or anticholinergic drug and mirabegron. Women provided a clean catch voided urine sample into a sterile container and were also catheterised using sterile non-touch techniques at the same clinic appointment. Patients testing positive for nitrites or who had a positive hospital MSU were excluded (2 patients). 100uL of each urine was plated in four conditions. Aerobic (48hour), in 5% CO2 enriched aerobic (48hours), anaerobic (7 days) and in campygen (7 days) and incubated at 35oC. Morphologically distinct colonies were identified and purity plated in the same conditions. Sterile water was used to lyse the bacteria and then polymerase chain reaction undertaken to amplify the 16s rRNA gene. The purified amplicon was sequenced to identify the bacterial genera by reference to an online database. The genera profile of each urine type was compared. Ethics approval was granted (ClinicalTrials.gov: NCT02536872). A formal power calculation was not performed as this was a proof of concept study.

Results: The mean age of the women was 55 years, with median parity of 2. All were white-british and the mean BMI was 31. Almost exclusively the plates from urine collected by MSU sample grew more colonies, although the numbers of colonies from both was too high to accurately quantify this suggest that the overall bacterial load was higher in the MSU urine samples. There were 42 different genera identified overall in all urine samples (32 different genera in CSU samples and 36 in the MSU samples) see fig 1.

figuream

There was no significant difference between the mean number of genera identified from CSU samples 4.8 (SD 2.3) and the mean number of genera identified from the MSU urine samples 5.6 (SD 2.6) (p=0.27). The mean number of genera that were present in both CSU and MSU for an individual was 2.6.

Conclusions: The overall bacterial load was higher in clean catch MSU samples. The genera profiles were similar in CSU and MSU samples but there was variation in the genera identified from the CSU and MSU samples from the same patient.

Disclosure:

Work supported by industry: no.

078

Validation of an obstetric fistula screening questionnaire

Chen, CCG 1 ; Long, A 1 ; Rwabizi, D 2 ; Mbabazi, G 2 ; Ndizeye, N 2 ; Dushimiyimana, B 2 ; Ngoga, E 3

1: Johns Hopkins; 2: University of Rwanda; 3: Rwanda Society of Obstetricians and Gyenecologists

Introduction: Most experts believe that obstetric fistula (OF) remains a significant cause of maternal morbidity in lower-resource countries; however, the global burden of disease is unknown. There currently is no well-validated, widely used OF screening tool. The screening questionnaire evaluated in this study was previously piloted and validated using a case-control design nested within a cross-sectional study in a low prevalence setting in rural Nepal.

Objective: To validate a symptom-based screening questionnaire for OF.

Methods: With an international panel of fistula surgeons, we developed and face validated an OF screening questionnaire which assessed for symptoms of lower urinary tract and lower gastrointestinal tract fistulas (LUTF, LGTF) and urinary and fecal incontinence, and also included a previously non-validated OF screening question used in many demographic health surveys (DHS). We determined the accuracy of these questions using a case-control study design. Cases were parous women who presented for care with possible fistula symptoms and subsequently confirmed to have fistulas on examination. Controls included parous women with and without incontinence symptoms who were confirmed not to have a fistula on examination. All women underwent the screening for fistula symptoms and a physical examination, with examiners blinded to screening results.

Results: Of the 367 women who completed the questionnaires and underwent clinical examination, 59 women had LUTFs and 34 had LGTFs, 174 women were classified as controls with and without symptoms of incontinence. All LUTF screening questions performed well, with the DHS screening question (Sometimes a woman can have a problem such that she experiences a constant leakage of urine or feces from her birth canal/vagina during the day and night. This problem usually occurs after a difficult childbirth, but may also occur after a sexual assault or after a pelvic surgery. Have you ever experienced (now or in the past) a constant leakage of urine and/or stool from your birth canal/vagina during the day and night?) demonstrating the highest sensitivity (100%; 95% CI 94%, 100%), specificity (95%; 95% CI 91%, 97%) and area under the curve (AUC, 0.973). The combination of a LGTF screening question (When you are not having a bowel movement, do you routinely/consistently experience feces passing through the birth canal/vagina that you cannot stop/control?) and question on fecal incontinence (We would like to ask you about any leakage of feces. Please do not include problems during short-term illness (such as a flu or virus/ diarrhea). Do you have problems with leakage of feces from the anus (accidents or soiling because of the inability to control the passage of feces until you reached a toilet)?) demonstrated the highest sensitivity (97%; 95%CI 85%, 100%), specificity (98%; 95% CI 95%, 99%) and AUC (0.981).

Conclusions: The OF screening questionnaire demonstrated high sensitivities, specificities and AUCs. This screening questionnaire has now been studied in two countries using two different study designs with different frequencies of OF, and has been shown to be highly discriminative for OF symptoms. We also determined the test-characteristics of a DHS OF screening question used to determine OF prevalence in many countries. Public health officials can utilize this information to report the global burden of disease from OF more accurately.

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079

What is the best cut-off value for the levator- urethra gap measurement in the diagnosis of avulsion defects?

Eisenberg, V 1 ; Vernikovsky, G 1 ; Lantsberg, D 1 ; Bitman, G 1 ; Alcalay, M 1

1: Sheba Medical Center Tel Hashomer and Sackler Faculty of Medicine Tel Aviv

Introduction: Levator avulsion is a risk factor for pelvic floor organ prolapse and prolapse recurrence after surgical repair. Avulsion diagnosis on transperineal ultrasound can be performed using tomographic ultrasound imaging (TUI) on volumes acquired on pelvic floor muscle contraction (PFMC). The levator-urethra gap (LUG) is the distance between the urethral lumen centre and levator insertion on the inferior pubic rami. It has been previously suggested that a LUG≥2.5 mm is another valid method to diagnose avulsion defects. However there appear to be ethnic variations which question the validity of this cut-off for widespread use.

Objective: To determine a cut-off value for LUG measurements in our patient population.

Methods: Women followed prospectively in our tertiary referral centre after sustaining labour trauma (OASI) underwent an interview, standardized pelvic floor questionnaires and 2D/3D/4D transperineal ultrasound examination. Levator avulsion was diagnosed on PFMC using TUI and abnormal insertion was determined in the three central slices. Ultrasound datasets were analyzed offline at a later time blinded to the clinical data and previous ultrasound measurements. LUG was measured on each side of the three central slices, yielding 6 measurements and an average for each side was obtained. Statistical analysis was performed using SPSS and a two-sided P-value of < 0.05 was considered statistically significant. Both methods were correlated and agreement between methods was determined. Different cut-offs were evaluated using ROC curve analysis.

Results: 507 complete datasets were available for analysis. The mean age was 28.9±4.9 years, the mean BMI 23.9±4.1 kg/m2, median parity 1, 73.4% were primiparous, instrumental deliveries – 25.6% of which forceps - 4.2%. None of them had previously undergone pelvic floor surgery. Mean LUG distances were: right LUG 2.15±0.56 mm, left LUG 2.12±0.53 mm. Data was analysed for groups based on the presence of avulsion. The relevant demographic data and levator measurements are described in Table 1.

Table 1: Demographic data and levator measurements in women with and without avulsion defects.

Parameter No avulsion Avulsion P value
Demographics N=269 N=238  
Age (years) 28±4.7 29.6±4.9 <0.001
BMI (kg/m2) 24.3±4.4 23.5±3.9 0.034
Forceps delivery (percentage) 2.1 5.9 0.042
Levator findings on ultrasound    
Levator rest area (cm2) 16.1±3.8 17.7±5.5 <0.001
Levator valsalva area (cm2) 22.3±7 25.3±8.1 <0.001
Levator contraction area (cm2) 12.2±2.8 15.7±5.3 <0.001
LUG right (mm) 1.83±0.28 2.42±0.61 <0.001
LUG left (mm) 1.84±0.26 2.37±0.59 <0.001

LUG measurements were higher with increasing age (P<0.001) and height (P<0.05). A cut-off of LUG≥2.5 missed 60.6% of avulsions, LUG≥2.3 missed 49.8%, LUG≥2.1 missed 34.2%, LUG≥2 missed 27.5%, LUG≥1.9 missed 18.6%, and LUG≥1.8 missed 11.9% of avulsions. An ROC Curve analysis including all possibilities outlined gave the best area under the curve for a cut-off of LUG=2.1 (Area 0.745, 95%CI 0.701-0.789, P<0.001). See Figure 1.

Figure 1: ROC curve analysis for the LUG cut-off

Conclusions: LUG distance measurement is useful but should be tapered based on the population studied. In our study the suggested cut-off value for diagnosing levator avulsion was 2.1 mm.

Disclosure:

Work supported by industry: no.

080

Anal incontinence: The role of the levator ani muscle in the absence of anal sphincter injury

Melendez Munoz, J 1 ; Subramanian, N 2 ; Friedman, T 2 ; Dietz, HP 2

1: Monash Health; 2: University of Sydney

Introduction: The puborectalis muscle, the most substantial part of the levator ani complex, is considered an important structure in anal continence. It is responsible for maintenance of the ano-rectal angle and opening or occluding the anal canal when relaxing or contracting respectively. (1) To date, there is however little evidence on the role of avulsion as a risk factor for anal incontinence, and the few studies performed on this issue do not control for anal sphincter trauma.

Objective: To determine any association between levator ani trauma and anal incontinence, while controlling for sonographic evidence of past anal sphincter injury.

Methods: The records of 1273 patients attending a tertiary urogynaecological unit with a complaint of pelvic floor dysfunction between January 2014 and December 2016 were retrospectively analysed. Patients had had a physician-directed interview including a St Marks score for anal incontinence (AI) and VAS (visual analogue scale) assessment of AI bother, and 4D translabial ultrasound for levator and sphincter imaging on pelvic floor muscle contraction (PFMC), as described previously.(2) Stored 4D pelvic floor ultrasound volume data sets were analysed offline with the help of proprietary software (4D VIEW V 10.0, GE Medical Systems), at a later date and blinded against all clinical data A complete avulsion was diagnosed if at least three central tomographic slices showed an abnormal muscle insertion, rated separately for each side. Significant external anal sphincter (EAS) defects were diagnosed if at least 4/6 slices had defects of 30 degrees or more of the EAS circumference.(3) We used logistic regression modelling to analyse any association between levator avulsion and measures of anal incontinence, controlling for anal sphincter trauma, age, body mass index and Forceps delivery.

figureao

Figure: Levator ani avulsion (A) and external anal sphincter trauma (B; ‘*’ indicate site of trauma.

Results: Mean age at presentation was 54 +/- 13 years. Mean BMI was 29 +/- 7. Median vaginal parity was 2 (2-3). 1142 (90%) women were vaginally parous of which 381 (30%) had had a forceps delivery and 414 (32%) a hysterectomy. 186 women (15%) complained of anal incontinence (AI) at a mean St Marks score of 12 and a VAS bother of 6 (range, 4-9). 144 (11%) of the entire population had significant residual anal sphincter trauma, and 318 (25%) had a Levator ani avulsion on tomographic US. Avulsion was associated with St Mark’s Score and VAS bother of AI as well as AI expressed as a binary variable, although the latter association became nonsignificant after controlling for anal sphincter trauma, age, BMI and forceps delivery; see Table.

  Association with levator ani avulsion
Univariate analysis Multivariate analysis*
P P
Anal Incontinence (yes/no) 0.011 0.084
St Marks’ score (0-24) 0.005 0.011
VAS bother of Anal Incontinence (0-10) 0.022 0.040

Table: Associations between levator ani avulsion and measures of anal incontinence; * controlling for residual EAS trauma on translabial imaging, Forceps, BMI and age (n=1273)

Conclusions: In this retrospective observational study we found a weak association between levator ani avulsion and measures of anal incontinence which largely remained significant when controlling for anal sphincter trauma.

References:

1. Neurogastroenterol Motil 2005; 17: 68–72.

2. Ultrasound Obstet Gynecol 2004; 23: 615–625.

3. J Ultrasound Med 2018; 37:263–280

Disclosure:

Work supported by industry: no.

082

The risk of cognitive impairment in patients starting anticholinergic medications for overactive bladder: a prospective trial

Iyer, S 1 ; Botros, C 2 ; Lozo, S 2 ; Eng, J 2 ; Sand, P 2 ; Tomezsko, J 2 ; Botros, S 3 ; Gafni-Kane, A 2 ; Sasso, K 2 ; Goldberg, R 2

1: University of Chicago; 2: North Shore University Health System; 3: The University of Texas at San Antonio

Introduction: Anticholinergic medications have been associated with cognitive changes but there is little data specific to anticholinergic medications used to treat overactive bladder (OAB).

Objectives: We aimed to assess cognitive changes in patients 6 months after starting anticholinergic therapy for OAB by comparing MOCA (Montreal Cognitive Assessment screening) scores over time between patients starting anticholinergic medications for OAB to those who did not.

Methods: We present a prospective cohort study assessing changes in cognition in naïve patients who started oxybutynin for OAB compared to patients not on anticholinergic OAB medications. The primary outcome measure was change over time in MOCA scores (0-30 points). Patients were enrolled from March 2015-June 2017. At the time of enrollment patients completed a baseline MOCA screening, a Geriatric Depression Screen (GDS), and assessment of current medications to create an anticholinergic burden score (ACB). At follow-up visits patients were administered a MOCA, GDS, and their current medications and medical problems were reviewed at 1, 3, and 6 months after enrollment. Exclusion criteria included non-English speaking or inability to complete follow-up schedule. Patients were not excluded if they had a neurological diagnosis or if they discontinued OAB medications. Statistical analysis (n=106) was done using a linear mixed effects model accounting for correlated error terms given multiple MOCA assessments at various time points per patient.

Results: 106 patients were enrolled, 60 in the OAB group and 46 in the control group. The mean age was 77 years old, 93% of patients were Caucasian, and 98% completed high school with no difference between groups. Patients were followed for 6 months with a mean of 2.48 visits with no difference between the groups. 24 (23.6%) patients in the OAB group and 23 patients (50%) in the control group only completed the baseline assessment and dropped out of the study or were lost to follow-up. In the OAB group 90% (54) of patients took medications for at least 1 month. Over time there was no difference in change in MOCA scores between the OAB and control groups when controlling for age, GDS score, and ACB score (p= 0.86). This association did not change when patients with a neurological diagnosis were excluded (n= 6). On average the control group’s linear change in the MOCA score was -0.11 points less than the OAB group (CI -0.18 - 0.03). A drop of 3.1 points on the MOCA is considered cognitive decline. As GDS score increased MOCA score decreased -0.29 points (p=0.05, CI -0.59 -0.00) and as age increased the MOCA score decreased -0.11 points (p= 0.003, CI -0.18 - -0.04) for the entire cohort. This correlation between GDS and age is consistent with the literature and was consistent between the groups.

Conclusion: While cognitive decline has been associated with anticholinergic medications, our study followed patients for 6 months with no changes found in MOCA scores after controlling for age, depression, and polypharmacy with the ACB score. A larger study with longer follow-up would better our understanding of cognitive changes associated with OAB anticholinergic medications.

Disclosure:

Work supported by industry: no.

083

Pelvic floor muscle training for female stress urinary incontinence: A randomized control trial comparing home and outpatient training

Fitz, F1; Gimenez, M1; Ferreira, L1; Bortolini, M1; Castro, R1

1: Federal University of São Paulo

Introduction: The pelvic floor muscle training (PFMT), performed in outpatient setting, is the first-line treatment for female stress urinary incontinence (SUI) (1). However, inadequate financial resources prevent the patients perform outpatient PFMT (2).

Objective: Primary objective is to compare the effect of home PFMT to outpatient PFMT in the cure of the SUI. Secondary objectives are to compare the efficacy of the two interventions in the pelvic floor muscle (PFM) function, quality of life and adherence.

Methods: Were included sixty-nine women with predominance of SUI and more than 2 grams (g) of leakage, as proven by a pad test. The exclusion criteria were had chronic degenerative diseases, pelvic organ prolapse greater than stage I, neurologic/psychiatric diseases, inability to contract PFM, previous pelvic floor re-education programs and surgeries. These women were randomized into two groups: outpatient PFMT and home PFMT. Both groups had daily sessions at home. The first one came to the clinic twice a week to the PFMT; and the second one came once a month to make adjustments in the treatment. The training protocol consisted of three sets of exercises daily for three months (one set: 8 maximum voluntary contractions held for 6-10 seconds, with double time rest between each contraction, followed by 3-5 fast contractions in a row). The outpatient PFMT group performed additional 24 outpatient sessions. Primary outcome was the cure of SUI by pad test (standardised bladder volume), defined as < 2 g of leakage. Secondary measures included: PFM function (Oxford scale); quality of life [Incontinence Quality-of-Life Questionnaire (I-QoL)]; adherence to home exercise sets (exercise diary).

Results: The home PFMT group (n=34) were similar to outpatient PFMT group (n=35) on key characteristics (age, parity, body mass index, duration of symptoms, pad test, quality of life). Both interventions showed significant changes from baseline to post-treatment (both p≤0.05).

Table 1. Primary outcome measure after 3-month treatment.

Objective cure - Pad test < 2 g Home PFMT Group (n=34) Outpatient PFMT Group (n=35) p OR (CI 95%)
  10 (28.6%) 21 (61.8%) 0.01 # 33.2% (61.8% – 28.6%)

Intention-to-treat analyses (with imputation of non-cured to the missing cases); #Chi-square

Table 2. Secondary outcome measure after 3-month treatment.

Oxford scale (0-5) Home PFMT Group (n=28) Outpatient PFMT Group (n=28) p
Grade 2 3 (10.7%) 5 (17.9%) 0.020 ##
Grade 3 21 (75%) 11 (39.3%)  
Grade 4 or 5 4 (14.3%) 12 (42.9%)  
I-Qol Domain    
Avoidance and limiting behaviour 139.2 (±37.2) 140.3 (±24.9) 0.576**
Psychosocial Impacts 179.4 (±37.6) 171.6 (±33.7) 0.149**
Social Embarrassment 59.8 (±22.9) 69.8 (30.7) 0.173*
Home exercise sets/month (n=0-90) (n=0-82)  
1st month 64.8 (±18.5) 76.4 (±8.8) 0,015**
2nd month 62.5 (±22.4) 74.6 (±11.1) 0,067**
3rd month 68.7 (±19.8) 75.6 (±9.4) 0,331**

Per protocol analyses; ##Likelihood ratio; **Mann-Whitney; *Student’s t-test

Conclusions: Outpatient PFMT presented significantly better results in primary outcome compared to home application of PFMT.

References:

1. Cochrane Database Syst Rev. 2014;5:CD005654.

2. Urol Nurs. 2006;26:41-51.

Disclosure:

Work supported by industry: no.

084

Translabial imaging of urethral diverticula

Pauline, G 1 ; Gillor, M 1 ; Dietz, HP 1

1: University of Sydney

Introduction: Urethral diverticula (UD) are an uncommon cause of lower urinary tract symptoms in women, said to occur in 0.02–6% of women worldwide (1). Diagnosis is important because UD can cause substantial morbidity, and because it is a correctable cause of lower urinary tract symptoms. There is often significant delay to diagnosis (2). Urethroscopy and/or MRI are used widely for diagnosis. 4D-translabial ultrasound (TLUS) is an alternative, especially since the development of 3D/ 4D imaging (3).

Objective: To review ten years of experience with UD evaluated by TLUS.

Methods: This was a retrospective review of patients seen for assessment in a tertiary urogyneacology unit between March 2008 and February 2018. 4121 women were examined by 3D/4D TLUS using a GE Kretz 730 expert system with RAB 8-4 MHz transducer. All had undergone urethroscopy with a zero degree office cystoscope. We collected data regarding demographics, presenting symptoms, and findings on examination. Archived 4D-TLUS volumes were analysed using proprietary software on a PC. Analysis included location of the diverticulum, diameters and tract visualization, echogenicity of contents and complexity.

Results: Of 4121 women seen during the inclusion period, 25 were found to have a major urethral abnormality on TLUS (0.6%). Of those, 17 had a cystic structure demonstrated while 8 showed other abnormalities such as multiple hyperechogenic foci and/ or architectural distortion. On urethroscopy, a UD was confirmed in 16; 13 of which had had a cystic structure demonstrated. Of 17 women with a paraurethral cystic structure traversing the urethral rhabdosphincter, 13 had a UD confirmed on urethroscopy (77%). Four were found to have vaginal cysts (2), Skene gland cysts or varicosities. In three confirmed UDs there were multiple hyperechogenic foci +/- urethral distortion. In other words, 3/8 (38%) women with multiple hyperechogenic foci +/- urethral distortion had a UD on urethroscopy. In the 9 cases without UD on urethroscopy, the urethral lumen was normal in 8, and in one case there was a stenosis that could be traversed with the cystoscope. In the 8 cases with normal lumen, the final diagnosis was ‘normal urethra’ in 4, vaginal cyst in 2, Skene gland cyst in one, and ‘vascular abnormality’ in one.

In the 16 patients with confirmed UD, mean age was 48 (33-70) years, mean parity was 2 (0-4). The principal symptom was stress incontinence in 9/16 (56%), urge incontinence in 8/16 (50%), frequency in 6/16 (38%), and recurrent UTIs in 7/15 (47%). Physical examination demonstrated an anterior vaginal wall mass in 7/16 (43%). All except one were posterior to the urethra. Mean maximum diameter was 13.4 mm (5-24 mm). The UD was simple in 8/13 (62%) or complex (i.e., multilocular and/or covering >80% of the urethral circumference) in 5/13. A tract was identified on TLUS in 11/13 (84%). The most common tract location was between 5 to 7 o’clock in 8/11 (73%). Mean urethral circumference covered by the UD was 41% (147°, 60-340°).

figureap

Figure: Imaging in women with UD in the midsagittal (A,C,E,G) and coronal plane (B,D,F,H). A,B: Hyperechogenic foci and distortion; C,D: small cystic structure; E,F: Simple posterior UD; G,H: Circumferential complex UD. Arrows indicate UD.

Conclusions: Translabial ultrasound is a valid non- invasive method for the diagnosis of urethral diverticula. Incidence is well below 1% in our population. A cystic structure traversing the urethral rhabdosphincter observed on TLUS has a high predictive value for the urethroscopic diagnosis of UD. Multiple hyperechogenic foci may indicate the presence of a small diverticulum. Sectional plane imaging helps in identifying diverticular tracts.

References:

1 J Urol. 1967 Jul;98(1):96-8.

2 Curr Urol Rep. 2015 Oct;16(10):71.

3 Clin Obstet Gynecol 2017; 60: 58–81

Disclosure:

Work supported by industry: no.

085

A review of mid urethral tape surgery (MUT) for stress urinary incontinence (SUI); patients requiring return to theatre for surgical management of mesh complications, further SUI and OAB surgery

Nicholson, R 1 ; Kershaw, V 2 ; Ballard, P 2 ; Khunda, A 2 ; Puthuraya, S 1 ; Gouk, E 1 ; Samarage, S 2

1: North Tees NHS Foundation Trust; 2: James Cook University Hospital

Introduction: Mid-urethral tape (MUT) procedures are commonly performed for the treatment of stress urinary incontinence (SUI) in women. Recent media coverage and the Scottish Independent review1 of vaginal mesh highlight mesh complications. A cohort study of mesh complications for SUI surgery in England, reported a complication rate of 9.8%2. The National Institute for Health and Care Excellence (NICE) recommend careful audit of outcomes for MUT. Complications according to NICE include failure (5-31%), erosion (0-4%), voiding dysfunction (0-18%), de novo over active bladder (OAB) symptoms (0-25%)3 and chronic pain. Surgical management of these complications therefore include a further SUI procedure, incision/excision of the MUT, injection of the tape with steroid, urethral dilatation, Botox® injections and sacral neuromodulation (SNS).

Objective: We aim to review the surgical management of complications of MUT in our units including a further SUI procedure for failure of the original MUT, incision/excision/injection of the MUT for erosion or chronic pain, Botox® injections and sacral neuromodulation (SNS) for de novo over active bladder symptoms and urethral dilatation for voiding dysfunction.

Methods: All patients coded to have a MUT procedure between 1/1/2010 until 31/12/14 in our Hospitals were reviewed retrospectively. Case notes were analysed for all patients who returned to theatre up until December 2017 due to complications related to their original MUT.

Results: 908 patients had an MUT procedure. 126/908 (13.9%) returned to theatre, the mean timing was at 28 months (range 0-81). 32/908 (3.5%) had procedures for mesh complications which included 26/908 (2.9%) having excision of the vaginal portion of the MUT, 6/908 (1%) having incision of the MUT and 6/908 (0.6%) having injection of the MUT for pain. 53/908 (5.8%) had a cystoscopy to investigate various symptoms including pain, voiding symptoms, recurrent UTI, OAB symptoms and haematuria. 6/908 (1%) had urethral dilatation. 17/908 (1.7%) had further SUI surgery; 11/908 (1.2%) had a repeat MUT, 3/908 (0.3%) urethral bulking, 1/908 (0.1%) autologous fascial sling and 2/908 (0.2%) colposuspension. 16/908 (1.7%) had surgical management of OAB including 12/908 (1.3%) with Botox® and 4/908 (0.4%) SNS. Further analysis will break the results down by the type of MUT, the presenting symptom, the efficacy of the above salvage procedures and the reason for cystoscopy.

Conclusion: The risk of return to theatre in our cohort up to 7years (mean 28months) following initial MUT to deal with complications including excision/incision/injection of the mesh is 3.5%, for further SUI surgery is 1.7% and for further surgery for OAB is 1.7%. Units should use their local results when counselling women.

References

  1. 1.

    https://www.england.nhs.uk/wp-content/uploads/2017/07/mesh-oversight-group-report.pdf

  2. 2.

    Complications following vaginal mesh procedures for stress urinary incontinence: An 8 year study of 92,246 women. Keltie. K et al, Scientific Reports (Nature) Vol 7, 2017.

  3. 3.

    Urinary incontinence in women: management

Clinical guideline [CG171] Published date: September 2013 Last updated: November 2015

Disclosure:

Work supported by industry: no.

086

Pelvic floor muscle activity during jumps in continent and incontinent women: An exploratory study

Moser, H 1 ; Leitner, M 2 ; Eichelberger, P 3 ; Kuhn, A 4 ; Baeyens, J 5 ; Radlinger, L 2

1: Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Bern, Switzerland and Faculty of Sport and Rehabilitation Sciences, Vrije Universiteit Brussel, Brussels, Belgium; 2: Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Bern, Switzerland ; 3: Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy, Bern, Switzerland and Graduate School for Cellular and Biomedical Sciences, University of Bern, Bern, Switzerland; 4: Bern University Hospital, Gynaecology, Bern, Switzerland ; 5: Faculty of Sport and Rehabilitation Sciences, Vrije Universiteit Brussel, Brussels, Belgium

Introduction: Urinary incontinence, is worldwide a very common condition and it shows a negative impact on quality of life. Among several forms of incontinence, stress urinary incontinence (SUI) is the most prevalent type. The overall costs generated by patients with SUI to society are tremendous. Even in female athletes SUI is a widespread problem. According to the International Continence Society SUI is defined as the complaint of involuntary leakage on effort or exertion or on sneezing or coughing [1]. SUI-provoking activities have a rise of intra-abdominal pressure and impact loading on the pelvic floor in common. To date, PFM activity during whole-body movements that potentially provoke urinary leakage is increasingly explored. The mode of muscle contraction during impact activities for the PFM is still unclear, especially during jumps. However, the importance of involuntary reflex activity of the PFM for continence has been recognized.

Objective: This study investigated PFM activity during jumps, by means of electromyographic (EMG) measurement to clarify the involuntary reflex activity of the PFMs. Women with SUI and continent women (CON) were tested during drop jumps (DJ) and counter movement jumps (CMJ).

Methods: Twenty-eight continent and twenty-two incontinent women aged between 18 and 60 years were included. A vaginal probe was used to record surface EMG activity of the PFMs during DJ and CMJ. Six time intervals of 30 ms were used to parameterize data from 30 ms before (pre-activity) to 150 ms after ground contact (reflex activity) on a force plate during the landing and take-off phase. All EMG signals were normalized to the mean of the peak values of two maximal voluntary contractions (MVC) and expressed in percentage (%MVC).

Results: The measurement of PFM activation during vertical jumps for continent and incontinent women showed no significant difference between the groups (P < 0.05). EMG values exceeded 100 %MVC for all time intervals during all landing and take-off phases. The mean of maximal PFM activation during the first landing of DJ was 404.1 SD 164.1 %MVC at 142 SD 53 ms after ground contact for SUI and 370.2 SD 139.1 %MVC at 155 SD 62 ms after ground contact for CON. The mean of minimal PFM activation between the take-off and second landing phase of DJ was 57.9 SD 42.6 %MVC at 210 SD 96 ms after take-off for SUI and 50.0 SD 29.4 %MVC at 214 SD 82 ms after take-off for CON. For CMJ it was 61.4 SD 43.4 %MVC at 238 SD 102 ms for SUI and 51.1 SD 23.3 %MVC at 252 SD 85 ms for CON.

Conclusions: Vertical jumps seem to stimulate pre-activity before and reflex activity after ground contact during the landing phase and activate PFMs up to 400 %MVC. Jumping stimuli inducing involuntary PFM contraction should be used for future investigations to consider a beneficial effect concerning continence.

References:

1.Urology, 2003. 61(1): p. 37-49.

Figure 1 Means and standard deviations (SD) for take off in the time interval (-350 ms to 300 ms) during drop jumps (DJ) for continent (CON) and incontinent (SUI) women. EMG electromyographic, %MVC normalized EMG on maximal voluntary contraction (MVC). CON Rest EMG onset for CON. SUI Rest EMG onset for SUI.

figureaq

Disclosure:

Work supported by industry: no.

087

Transcutaneous tibial nerve electrical stimulation combined with transvaginal electrical stimulation in the treatment of overactive bladder syndrome: a blind randomized clinical trial

Giarreta, F1; Haddad, J2; Fusco, H2; Baracat, E2; Casarotto, R2; Ferreira, E2

1: University of São Paulo - USP; 2: University of Sao Paulo - USP

Introduction: Overactive bladder syndrome (OAB) has been defined as “urgency with or without urge incontinence, usually with frequency and nocturia”1. It is a high prevalent syndrome that negatively affects women’s quality of life and the diagnosis is based on clinical symptoms. Treatment options include behavior therapy, pharmacotherapy and physiotherapy which usually uses Transcutaneous Tibial Nerve Stimulation (TTNS) and Transvaginal Electrical Stimulation (TES) as well-established conservative treatment with minimal adverse effects2,3.

Objective: To verify whether the association of TES+TTNS is more effective than the use of TTNS for the treatment of women with OAB.

Methods: This is an ongoing randomized, assessor-blind clinical trial conducted at the physiotherapy outpatient in a hospital. It was approved by the Ethics Committee and is registered at www.ClinicalTrials.gov . Inclusion criteria: women over 18 years old with diagnosis of OAB or mixed urinary incontinence with predominance of OAB symptoms. Sample size calculation was 102 women, and up to this moment 90 patients were enrolled. The participants were randomly allocated to two groups: TTNS group (G1) and TES+TTNS group (G2). All patients signed a free and informed consent form.

Assessment instruments: three-day voiding diary, King´s Health Questionnaire (KHQ) and Overactive Bladder Questionnaire (OAB-V8). Pelvic floor muscle strength was evaluated with digital palpation. All participants were assessed before and after treatment and both groups were oriented for bladder training. TTNS was performed with Dualpex 961 Quark® equipment (pulse frequency=10Hz, pulse width=200μs) for 30 minutes, once a week, for 12 weeks. For G2, the same technique for TTNS was applied and after that, the patient was placed in a lithotomy position for TES with a vaginal electrode for 20 minutes (pulse frequency=10Hz, pulse width=1ms). The intensity was the highest tolerated by the patient without reaching the motor limiar. Descriptive analysis was performed. Chi-square or Fisher test, Mann Withney test and Wilcoxon test were used for comparisons. Statistical analysis was performed with Software R, versão 3.1.3.

Results: So far, 58 women completed the treatment (n=33 for G1 and n=25 for G2), 22 are under treatment and 10 abandoned the study. The median age was 66 years old for G1 and 53 years old for G2; 87.9% of women were in menopausal status for G1 and 70.8% for G2. Mean parity, menopausal status and mean body mass index didn´t show statistic differences. After treatment, improvement was observed in both groups. Comparing the difference between pre and post treatment, there was not statistical significance for the KHQ, OAB-V8 and voiding diary in the intergroups analysis, however, G2 presented better results than G1 for pelvic floor muscle strength (p=0,0009).

Conclusion: Partial results of 58 women treated for OAB showed improvement in both groups, however, up to this moment, the only outcome that presented statistical significance between groups was the pelvic floor strength, for which TTNS+TES had better results when compared to TTNS alone. In relation to the OAB symptoms there was no difference between groups.

References:

1 Am J Obstet Gynecol 2002;187:116-126

2 Rev Bras Ginecol Obstet 2007;29:452-8

3 J Urol 2003;169:2210-2215

Disclosure:

Work supported by industry: no.

088

Critical appraisal of non-neurogenic overactive bladder clinical practice guidelines using the AGREE II instrument

Plata, M 1 ; Bravo-Balado, A 1 ; Ramos, A 2 ; Trujillo, CG 1 ; Caicedo, JI 1 ; Serrano, A 1 ; Cataño, JG 2

1: Department of Urology, Hospital Universitario Fundación Santa Fe de Bogotá and Universidad de los Andes School of Medicine, Bogotá D.C., Colombia.; 2: Department of Urology, Hospital Universitario Fundación Santa Fe de Bogotá, Bogotá D.C., Colombia.

Introduction: The benefits of clinical practice guidelines (CPGs) are as good as the quality of the guidelines themselves1. Rigorous methodologies for their elaboration are imperative for an appropriate implementation of the resulting recommendations2. There is a growing interest concerning the reliability of guidelines given the great variability in their quality3. To date, there are no studies aiming to evaluate the quality of overactive bladder (OAB) CPGs.

Objective: To critically appraise non-neurogenic OAB CPGs.

Methods: A systematic review of the literature was independently conducted by two investigators in March 2017 and updated in November 2017. Data sources included MEDLINE, EMBASE, Google Scholar and the National Guideline Clearinghouse from 2006 to 2017. We included non-neurogenic OAB and urinary incontinence (UI) CPGs that included within the same guideline recommendations related to OAB, published in English. Five urologists independently appraised CPGs using the Advancing Guideline Development, Reporting and Evaluation in Health Care instrument II (AGREE II)1; they were trained in the use of this instrument before starting quality assessment. A consensus was achieved by reviewing each individual evaluation in a weakly group meeting.

Results: Fourteen non-neurogenic OAB CPGs written in English were published between 2006 and 2017. After eliminating for duplicates and titles and abstracts were screened, we included seven guidelines. The National Institute for Health and Care Excellence guideline on UI in women performed best in all domains, with the highest scores being clarity of presentation (97%) and editorial independence (95%), and an overall assessment (OA) of 97%; all five evaluators would recommend this guideline without modifications. This was followed by the EAU Guidelines on UI in Adults, with the best performance in clarity of presentation (98%) and scope and purpose (87%), and an OA of 73%; in this case, 3 evaluators would recommend this guideline without modifications and 2 with modifications. The AUA/SUFU guideline had an OA of 67%, followed by the guideline endorsed by the Society of Obstetricians and Gynaecologists of Canada with 63%. Finally, the Canadian Urological Association Guideline on Adult OAB, the Conjoint Urological Society of Australia and New Zealand and Urogynaecological Society of Australasia Guidelines and the Clinical Guidelines for OAB endorsed by the Japanese Urological Association had OAs of 43%, 33% and 30%, respectively. Main deficiencies were found in the applicability domain (23.0%±33.2, range 3-79%) and stakeholder involvement (40.9%±27.3, range 15-91%).

Conclusions: This is the first study aiming to critically appraise non-neurogenic OAB CPGs. Many limitations were found, especially when it comes to evaluate the implementation and adherence to the guidelines’ recommendations. There is a need for including all relevant professionals in the development of OAB CPGs, such as physical rehabilitators and geriatricians, among others.

  1. 1.

    Brouwers MC, et al. AGREE II: Advancing guideline development, reporting and evaluation in health care. J Clin Epidemiol. 2010;63(12):1308-1311.

  2. 2.

    Grol R. Successes and failures in the implementation of evidence-based guidelines for clinical practice. Med Care. 2001;39(8 Suppl 2):II46-54.

  3. 3.

    Grilli R, et al. Practice guidelines developed by specialty societies: the need for a critical appraisal. Lancet. 2000;355(9198):103-106.

Disclosure:

Work supported by industry: no.

089

Mobile App increases the adherence of pelvic floor muscles training for women with urinary incontinence

Juliato, C 1 ; Araujo, C 1 ; Marques, A 1

1: University of Campinas

Introduction: Adherence is the key for pelvic floor muscle training (PFMT) success and essential for long-term efficacy of urinary incontinence treatment (1).

Mobile health apps are a growing field that offers new possibilities for delivering health services, which enable people to increase adherence to treatment (2).

Objective: Was to evaluate the utilization of a mobile app specifically developed for the treatment of urinary incontinence in the adherence of domiciliary PFMT and its impact at the urinary symptoms.

Methods: A pilot, prospective, randomized, single-blind, parallel study including women stress urinary incontinent (SUI).

The diagnosis of SUI was based on a demonstration of urinary leakage on straining or coughing with a comfortably full bladder.

The exclusion criteria included pelvic organ prolapse, neurologic impairment that jeopardize the capacity of comprehension, symptoms suggestive of neurogenic bladder and extreme PFM condition obtained after initial vaginal palpation, as hyperactivity or complete inability to contract.

Women were randomized into two different groups: “Group 1” this group received a mobile app specially developed by our research group in collaboration to Eldorado Institute of Technology, which was called ״Diario Saude®” mobile application (app).

The app was developed using the same visual component of electromyographic (sEMG) as a guide for PFMT.

At home, women were asked to repeat it, now without sEMG help, but following the visor or “Group 2- Patients from this group received written instructions for domiciliary PFMT. The image of muscular contraction presented in the paper was the same obtained through sEMG visor (Control).

Exercises should be done 2 times a day.

Reevaluation was repeated at one, two and three months after initial evaluation. Changes of urinary and vaginal symptoms were access using the followed questionnaires: Subjective Improvement Perception, ICIQ-VS (International Consultation on Incontinence Questionnaire – Vaginal Symptoms), ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form), FSFI (Female Sexual Function Index), QUID (Questionnaire for Urinary Incontinence Diagnosis). Also, to complete muscular evaluation, digital palpation was done using Oxford Modified Scale.

Results: 33 women were including in the study: 17 in Group 1-APP and 16 in Group 2-Control.

There was significant difference regard the number of exercise repetition at Group 1-App after one month (0.009), two months (p=0.001) and three months (p=0.001) of follow-up (Graphic 1).

No significant difference were notice at the questionnaires, but subjective improvement perception were significant higher at Group 1- APP in all of reevaluation moments (p=0.03, 0.01 and 0.005).

After two months of PFMT, there was significant difference at the “FAST” aspect (p=0.011) at Group 1- App.

Conclusion: The utilization of mobile app increased the adherence for PFMT of women with urinary incontinence symptoms and the improvement subjective perception.

1. Neurourol Urodyn. 2015 34(7):600-5

2. J. Med Internet Res. 2015, 24;17(2):e52

figurear

Graphic 1. The number of exercise repetition in one months, two months and three months of follow-up.

Disclosure:

Work supported by industry: no, by Cássia Juliato.

090

A novel wearable, intravaginal device for continuous neuromodulatory treatment of overactive bladder

Sutherland, S 1 ; Siegel, S 2

1: University of Washington, Seattle, WA; 2: Metro Urology, Mpls/St Paul, MN

Introduction: The FemPulseTM device delivers electrical stimulation through the vaginal wall adjacent the cervix to stimulate autonomic nerves and plexuses between the bladder and CNS to treat overactive bladder (OAB) with/without urge urinary incontinence (UUI).

Objectives: Serving as an initial feasibility study, the primary objectives were to evaluate device fit, comfort, wearability and safety. Secondary objectives were to assess potential for impact of FemPulseTM stimulation on OAB symptoms in patients with/without UUI.

Methods: Twelve subjects completed the study. There were 3 sessions for each subject. The first session assessed device fit, comfort, self-management of the device, and assessment of sensation thresholds, tolerability and safety. The next two six-hour sessions involved a randomized, blinded, crossover design with washout, assessing the effects of stimulation via bladder diaries and questionnaires. Safety monitoring was performed in all sessions via Holter monitor, serial blood pressure, heart rate assessments and symptom reporting. Results for stimulation versus sham arms were compared.

Results: The FemPulseTM device fit all subjects properly and was deemed comfortable. Most subjects easily manipulated and oriented the device within the vagina. All subjects were able to identify and localize anatomically sensations at 3 thresholds on each of 8 electrode combinations. There were no safety concerns, cardiac-related or otherwise, nor device-related adverse events. Findings comparing stimulation versus sham data noted a reduction in urge-related bother in 50% of subjects as compared to their baseline (6 of 12 subjects); a longer maximum time between voids (+24% versus sham) in 67% of subjects (8 of 12 subjects); and achievement of a dry status in 57% of subjects who were confirmed with UUI during the study (4 of 7 subjects), as compared to 0% dry status in the sham arm.

Conclusions: The FemPulseTM intravaginal device is wearable, safe and provides a promising non-surgical form of continuous neuromodulation delivery for the treatment of OAB and UUI. Further study is currently underway to further assess the efficacy of this therapy for the treatment of OAB.

figureas

Disclosure:

Work supported by industry: yes, by FemPulse, LLC.

091

The eCoin™ implantable tibial nerve stimulation device for overactive bladder syndrome

Sand, P 1 ; Sen, S 2 ; Lucente, V 3 ; Clark, M 4 ; Kaaki, B 5 ; English, S 6 ; Gilling, P 7 ; Meffan, P 8 ; MacDiarmid , S 9

1: University of Chicago, NorthShore University HealthSystem; 2: Stanford University Medical School; 3: The Institute for Female Pelvic Medicine and Reconstructive Surgery; 4: The Clark Center for Urogynecology; 5: UnityPoint Clinic; 6: Canterbury Urology Research Trust; 7: Tauranga Urology Research Ltd; 8: Roundhay Medical Center; 9: Alliance Urology Specialists

Introduction: Overactive bladder syndrome (OAB) may be treated through stimulation of the posterior tibial nerve but treatment needs to be done in the office weekly for 12 weeks initially and then every 3-4 weeks to maintain benefit. This limits patient compliance and persistence on therapy.

Objective: To assess the efficacy and safety of an implantable, automated stimulator of the posterior tibial nerve on OAB.

Methods: A prospective, international, multicenter 12 week trial of the novel implantable eCoin™ system for posterior tibial nerve stimulation (PTNS) was conducted to evaluate changes from baseline in OAB symptoms on bladder diaries and patient reported outcomes after 12 weeks of treatment at 7 centers. 46 subjects were implanted with the eCoin™ device over the posterior tibial nerve under local anesthesia at baseline (Figure) and then automatically treated for 30 minute sessions. Subjects completed 3-day bladder diaries to assess changes in voiding symptoms at 4, 8 & 12 weeks from baseline. Safety was evaluated by reported adverse events. Two-tailed t-tests were used to compare the means of the bladder diary data from baseline to study completion.

Results: Three of the 46 subjects were excluded, one who was explanted prior to receiving treatment and two because of incomplete baseline data. The mean age of the 46 subjects implanted was 63.4± 11.5 years. After 12 weeks of treatment there was a 63% reduction in urgency urinary incontinence episodes (UUI). There was a mean change in UUI/ day of -3.29 ± 2.99 with a mean baseline of 5.24 ± 2.93 at three months in the 43 subjects (p=0.001). UUI fell to 2.17 episodes/day at 2 months and to 1.95 episodes/day at 3 months. There was a 50% reduction in UUI at 3 months in 70% of subjects and a 75% reduction in UUI in 44% of subjects. Twenty-three percent of subjects had no leakage episodes after 12 weeks of treatment with eCoin.™ Urinary frequency was reduced by 25% or by 3.4±2.2 voids/day from 12.6±2.3 voids/day at baseline (p=0.001). Urinary urgency episodes occurred 6.8±3.8 times/ day and were reduced by 39% or 3.0±3.6 episodes/day (p=0.001). Serious adverse events were noted in 3 subjects. Cellulitis secondary to an ankle wrap occurred in one subject, one subject had a limp with leg edema at screening, and one had an unrelated pneumonia.

Conclusions: These data, showing a dramatic improvement in UUI, suggest great promise for eCoin™ stimulation of the posterior tibial nerve to treat OAB without the need for weekly office visits.

figureat

Figure

Disclosure:

Work supported by industry: yes, by Valencia Technologies. A consultant, employee (part time or full time) or shareholder is among the authors (Valencia Technologies).

092

Comparison between Polyvinylidene fluoride and Polypropylene transobturator-suburethral tapes: Preliminary results from a multicentre randomized trial

Sabadell, J 1 ; Pereda, A 2 ; Ojeda, F 3 ; Urbaneja, M 4 ; Palau, M 5 ; Camps, N 6 ; Genover, E 7 ; Canet, J 8 ; Asuero, M 9 ; Perez-Espejo, MP 9 ; Montero-Armengol, A 1 ; Rodriguez-Mias, N 1 ; Salicrú, S 1 ; Gil-Moreno, A 1 ; Poza, JL 1

1: Hospital Vall d'Hebron; 2: Hospital de Granollers; 3: Hospital Quiron Sagrado Corazón; 4: Hospital Virgen del Rocío; 5: Hospital de Viladecans; 6: Hospital de Bellvitge; 7: Hospital de Mataró; 8: Hospital Santa Caterina; 9: Hospital General de Riotinto

Introduction: Polyvinylidene fluoride (PVDF) has been proposed as an alternative to polypropylene (PP) for its use in suburethral slings. Owing to its biocompatibility and biomechanical properties it has been hypothesized that PVDF slings could be associated with less mesh-related complications.

Objective: To describe and compare the effectiveness and complication rates of PVDF and PP transobturator suburethral tapes (TOT).

Methods: Preliminary results of a multicentre RCT are presented. Women were randomized to undergo PP or PVDF TOT. A block-randomization procedure, stratified by centre, was performed. Allocation to trial group was carried out by a central computer system. Women with pure stress urinary incontinence or stress-predominant mixed urinary incontinence were eligible. Postoperative follow-up was performed at one, six and twelve months. Outcomes were classified as cured, improved or failed defined by combined objective and subjective criteria. The main outcome was the cure-improvement rate at 1-year. Sandvik’s and ICIQ-SF questionnaires were completed before and 1-year after surgery. Patient global impression of improvement (PGI-I) questionnaire was also completed at 1-year. Complications are also reported. Outcomes were analysed in an intention-to-treat basis.

Results: Recruitment of participants was closed after reaching the calculated sample size (n=282; participants actually recruited=288). Based on last data actualization, 126 women were allocated to PP and 127 to PVDF. Both groups were similar regarding their initial characteristics. 143 women have completed 1 year follow-up. The cure-improvement rate in this cohort was 92.9% and 94.5% in the PP and PVDF groups respectively (p=0.74). Changes in questionnaires scores were also similar (table 1). Based on the PGI-I score, patients find themselves to be mostly very much better after surgery with both sling materials. Complications are detailed in table 2. More cases of persistent pain were observed in the PP group (4.8% vs. 0%; p=0.014).

Conclusions: The interim data analysis of this RCT finds that PVDF has similar effectiveness than PP when used in TOTs. Complication rates are also similar, however more cases of persistent pain are observed in the PP group. All these observations should be corroborated with the final complete data analysis.

Table 1. Questionnaire scores.

  Pre-operative Post-operative p Within Group p Between Groups
  PP PVDF PP PVDF PP PVDF
Sandvik 8 [8 to 12] 8 [8 to 12] 0 [0 to 3.5] 0 [0 to 3] 0.000 0.000 0.57
ICIQ-SF 16 [13 to 18] 16 [14 to 18] 0 [0 to 6] 0 [0 to 6] 0.000 0.000 0.81
VAS 8 [7 to 10] 8 [7 to 10] 0 [0 to 2.5] 0 [0 to 2] 0.000 0.000 0.76
PGI-I    1 [1 to 2] 1 [1 to 2]    0.30

Data expressed in Median [Interquartile range]

Table 2. Complications

  PP PVDF p
Intraoperative 6 (4.9%) 4 (3.2%) 0.54
Early postoperative    
Temporary elevated PVR 8 (6.3%) 9 (7.1%) 0.82
Cystitis 2 (1.6%) 2 (1.6%) 1
Groin/obturator pain 2 (1.6%) 4 (3.1%) 0.68
Late postoperative    
Groin/hypogastric pain 6 (4.8%) 0 (0%) 0.014
Suburethral granuloma 2 (1.6%) 1 (0.8%) 0.62
Tape erosion 2 (1.6%) 1 (0.8%) 0.62
De novo urgency 13 (20.6%) 8 (12.7%) 0.23
Sling division 2 (3.2%) 0 (0%) 0.50

Disclosure:

Work supported by industry: yes, by Cardiolink.

093

No increased risk of clean intermittent catheterization with onabotulinumtoxinA retreatment in female patients with overactive bladder syndrome: Pooled analysis of randomized controlled trials

Robinson, D 1 ; Cruz, F 2 ; Rovner, E 3 ; Sobol, J 4 ; McCammon, K 5 ; Hamid, R 6 ; Radomski, S 7 ; Sand, P 8 ; Orejudos, A 9 ; Patel, A 10 ; Lemack, G 11

1: King’s College Hospital NHS Foundation Trust, London, UK; 2: Hospital S. João & Universidade Do Porto, Porto, Portugal; 3: Medical University of South Carolina, Charleston, SC, USA; 4: Michigan Institute of Urology, West Bloomfield, MI, USA; 5: Eastern Virginia Medical School, Norfolk, VA, USA; 6: University College London Hospitals, London, UK; 7: University of Toronto, Toronto, Canada; 8: University of Chicago, Chicago, IL, USA; 9: Allergan plc, Irvine, CA, USA; 10: Allergan plc, Marlow, UK; 11: University of Texas Southwestern Medical Center, Dallas, TX, USA

Introduction: OnabotulinumtoxinA has previously been associated with the potential need for clean intermittent catheterization (CIC) in patients with overactive bladder (OAB) syndrome. However, the risk of recurrent CIC in patients undergoing repeat treatment with onabotulinumtoxinA requires further characterization.

Objective: A post hoc analysis of pooled placebo-controlled trials was undertaken to evaluate the risk of CIC as well as efficacy and quality of life (QOL) outcomes following reinjection with onabotulinumtoxinA 100U in female patients with OAB.

Methods: Female OAB patients who received onabotulinumtoxinA 100U or placebo in 3 phase 3 randomized controlled trials and a randomized controlled postmarketing study were included (N=1362). Rates of CIC (>1 day duration) were evaluated over 12 weeks following treatments 1 and 2. Patients could be re-treated with open-label onabotulinumtoxinA 100U if requested and if the predefined criteria of ≥2 urinary incontinence (UI) episodes in a 3day bladder diary and an interval of ≥12 weeks since the prior treatment were met. The percentage change from baseline in UI episodes/day, proportions of patients with 100% reduction in UI episodes/day (ie, became “dry”), mean changes from baseline in King’s Health Questionnaire (KHQ) Role (RL) and Social Limitations (SL) domains, and proportions of patients with improvements on the Treatment Benefit Scale (TBS) were assessed at week 12 after treatments 1 and 2. Adverse events were recorded.

Results: CIC rates for female patients in the 12 weeks following the first treatment were 5.2% (38/729) for onabotulinumtoxinA and 0% (0/633) for placebo. In the 12 weeks after the second treatment, CIC rates were 3.9% (16/413) for those receiving onabotulinumtoxinA for a second time; the majority of which were de novo CIC patients (11/413, 2.7%) who had not had CIC following their first onabotulinumtoxinA treatment. Only 5 patients required CIC within 12 weeks following both treatments 1 and 2. The CIC rate was 2.9% (15/510) for patients who received their first onabotulinumtoxinA treatment in treatment cycle 2 (ie, those receiving placebo at treatment 1). The percentage decrease in UI episodes/day from baseline after treatment 1 was greater at 12 weeks with onabotulinumtoxinA vs placebo (-56.2% vs -14.6%; baseline: 5.4 and 5.5, respectively). At 12 weeks, 29.9% of onabotulinumtoxinA- vs 6.9% of placebo-treated patients became dry, achieving a 100% reduction in UI episodes/day. Following the first treatment, mean changes from baseline in KHQ RL and SL domains with onabotulinumtoxinA were greater than with placebo and exceeded the minimally important difference of -5 points (22.8 vs -3.6 and -22.6 vs -6.4, respectively). The proportion of patients with improvement/great improvement on the TBS at 12 weeks after the first treatment was 57.2% with onabotulinumtoxinA and 26.4% with placebo. Similar changes in UI and QOL were observed following the second treatment. No unexpected safety signals were observed, and urinary tract infection was the most common adverse event with onabotulinumtoxinA.

Conclusions: In this large, pooled population of female OAB patients, no increased risk of CIC was observed with onabotulinumtoxinA retreatment. OnabotulinumtoxinA 100U improved UI and QOL and was well tolerated.

Disclosure:

Work supported by industry: yes, by Allergan plc. A consultant, employee (part time or full time) or shareholder is among the authors (Allergan plc).

094

Botulinum Toxin. It's not what you do, it’s the way that you do it

Thiagamoorthy, G1; Flint, R1; Rantell, A1; Rajshekhar, S1; Robinson , D1; Cardozo, L1

1: King's College Hospital

Background: Anecdotally there seems to be considerable variation in the practical steps taken during intravesical treatment with Botulinum Toxin (BTX). Contrary to the initially held theory, recent data suggest that trigonal BTX injection is safe and may even have superior OAB efficacy.1,2 With this in mind, we decided to enquire about the real-life practices of those using intravesical BTX around the world to determine if any practices may be worth investigating further.

Methods: A 31 question online questionnaire was created in conjunction with BSUG, EUGA and IUGA then distributed via ‘email-blasts’ to the organisations’ membership.

Results: Between October 2017 and March 2018 232 responses were received (78.5% Urogynaecologists, 12.9% Urologists, 8.2% General gynaecologists, 0.4% nurse-cystoscopist). The professionals practiced in 39 different countries, majority in the UK (37.9%) and USA (15.5%). When looking at procedural practicalities, 46.1% conducted their procedures under local anaesthetic, with 34.7% using general anaesthetic and 11.0% using conscious sedation. The majority of practitioners used a day-case facility (48.3%), with 37.3% using an outpatient/office based approach and 14.5% electively admitting the patient to hospital. When looking at choice of scope 75.9% used a rigid scope with 24.1% using a flexible scope. Abobotulinumtoxin A (Botox®) was the brand most commonly used (94.6%). Most (84.1%) recommended antibiotic cover of some sort for the procedure and 47.0% also recommended antibiotics post-procedure. Of the type of antibiotics used, 32.5% prescribed a quinolone, 32.0% prescribed a cephalosporin, 19.8% prescribed an aminoglycoside and 7.3% prescribed trimethoprim. Aminoglycosides are known to potentiate the effects of botulinumtoxin3 and so should therefore should be used with caution. If signs of infection were present, despite this 22.6% would still go on to inject, with 77.4% refraining. Preoperatively 50.9% of practitioners did not require their patients to learn how to perform clean intermittent self-catheterisation. For idiopathic DO, 63% injected 20 sites, 22.0% ten sites, and 6.2% ≥30 sites. The largest difference in practice was whether or not to inject into trabeculations, 46.3% did whilst 53.7% did not. The next was the decision to create a bleb or not, 60.8% vs 39.2% respectively. 73.6% had not injected into the trigone, but of those who had, 81.5% found no problems, 10.8% thought the patients found it more painful and 3.1% stated that their patients developed vesico-ureteric reflux. Post treatment 25.0% of practitioners did not undertake a post-void residual. When looking at repeat injections, the majority of people would repeat injections following 6 to 9 months (70.8%) followed by 9 months to 1 year (23.5%)

Conclusion: These data provide insight into variations in clinical practice. Closer analysis of the different steps particularly injecting into trabeculations and whether or not to create a bleb are of significant interest as opinion seems truly divided. Randomised controlled studies may assist determining whether varying any of these steps can achieve improved efficacy for our patients.

References:

  1. 1.

    Jiang YH et al. Comparative study of efficacy and safety between bladder body and trigonal intravesical onabotulinumtoxin a injection in the treatment of interstitial cystitis refractory to conventional treatment- A prospective, randomized, clinical trial. Neurourol Urodyn. 2018 Jan 13.

  2. 2.

    Jo JK et al. The effect of onabotulinumtoxinA according to site of injection in patients with overactive bladder: a systematic review and meta-analysis. World J Urol. 2017 Nov 9

  3. 3.

    Santos et al. Potentiation of Clostridium botulinum toxin aminoglycoside antibiotics: clinical and laboratory observations. Pediatrics. 1981 Jul.

Disclosure: Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Allergan, pfizer, Feering, Astellas, cogentix, colloplast, mediplus, bard).

095

Sacral neuromodulation and sexual function: A systematic review and meta-analysis

Khunda, A 1 ; Anderson, C 2 ; Ballard, P 2

1: South Tees Hospitals NHS Trust ; 2: South Tees Hospitals NHS Trust

Introduction: The therapeutic indications for Sacral Neuromodulation (SNM) are expanding rapidly, but its effect on sexual function has mostly been a secondary outcome. The effect could be indirect through improvement in functional bladder and bowel related symptoms, or direct through stimulation of the sacral nerve routes. Previous reviews were mostly non-systematic and did not pool the data together.

Objectives: We set out to systematically review the literature concerned with the effect of SNM and sexual function according to the principles of the PRISMA statement. We also intended to perform meta-analysis, where appropriate, for the primary outcome and for subgroups according to age, indication, type of patients and industry involvement. Furthermore, we aimed to assess changes in each individual component of sexual function: Desire, arousal, lubrication, orgasm, pain and satisfaction.

Method: The following keywords and their variations were used: “sacral”, “neuro?modulation”, “nerve* stimulation” and “sex*” in searching Medline, Embase and Researchgate. The last search was updated on 17/2/2018. After excluding duplicates and irrelevant articles, 25 studies were assessed for eligibility. After contacting authors for further information, 17 studies were included in the qualitative synthesis and 14 studies were included in the quantitative synthesis.

Results:11 studies, which reported on the primary outcome (general sexual function) in 573 patients before SNM and 438 patients after SNM using continuous measurement tools, were included in our primary meta-analysis. SNM had a positive effect on sexual function with a SMD of -0.39 (95% CI=0.58, -0.19); I2=37%; P= 0.0001. Two studies used categorical tools and reported on sexual function in 56 patients before SNM and 53 patients after SNM showing a positive effect with an odds ratio of 0.33; 0.11-1.03; P= 0.06. The positive effect of SNM on sexual function remained true when only the top (5) high quality studies or studies in which mean patients age was less than 51 (3) were included, when studies with neuropathic patients (3), studies with patients suffering from pain (2) or studies which declared industry sponsorship (4) were excluded. Studies in which SNM was done for urinary indications (9) retained a positive effect on sexual function, whilst studies in which SNM was done for fecal incontinence (2) did not. In our secondary analysis, we examined changes in components of the Female Sexual Function Index (FSFI): There was a strong trend towards improvement in desire after SNM (-0.33; -0.66 to 0.00; p= 0.05). There was a significant improvement in arousal (-0.36; -0.66 to -0.05; P= 0.02), lubrication (-0.26; -0.53 to 0.01; p =0.06) and satisfaction (-0.41; -0.72 to -0.09; p =0.01), but not in orgasm (-0.28; -0.57 to 0.02; p= 0.06) or pain (-0.28; -0.49 to -0.08; p= 0.007).

Conclusion: This review presents the most comprehensive review of the evidence related to the effect of SNM on sexual function. There seems to be a positive effect, mainly delivered via improvement in desire, arousal, lubrication and satisfaction. Our review opens the door for primary research using sexual function as the primary outcome.

Disclosure: Work supported by industry: no.

096

Antibiotic resistance and the treatment of chronic UTI

Swamy, S 1 ; Dharmasena, D 1 ; Malone-Lee, EPJ 1

1: University College London

Background: Antibiotic discovery, modes of action, mechanisms of resistance and rise in the resistance rates have been productive research topics in academia (1,2). The development of antibiotic-resistant microbe’s results from many years of unremitting selection pressure from human applications of antibiotics, via underuse, overuse, and misuse. Whilst man has created the circumstances, there is perhaps no better example of the Darwinian selection and survival. The prime source of antibiotic resistance is the agricultural industry. While inappropriate use in humans for viral infections is wrong, the withdrawal of treatment from needy patients in order to reduce overall use is inappropriate. Chronic LUTS patients who present with pyuria and negative MSU are treated with long term antibiotics at this service. This has provoked criticism from microbiologists and clinicians because of resistance fears.

Aim: To test the resistance rates of microbes in chronic LUTS patients on long term antibiotics and acute UTI patients who were yet to commence therapy.

Methods: We conducted a retrospective observational study from January 2015 to September 2015 comparing the resistance of microbes between LUTS patients with a positive MSU compared to microbes from A&E patients with acute UTI. All LUTS clinic patients were on long term full dose first generation antibiotics and the A&E patients were not on antibiotics at the time of sampling.

Results Positive MSU cultures were noted in 471 LUTS patients and 781 A&E acute UTI patients. Independent sample T test (SPSS22) on the MSU culture data showed no difference in the resistance count between the two groups (Graph 1).

Conclusion These observational data suggest that long term antibiotic therapy in this context did not cause an increase in microbial resistance counts in LUTS clinic patients compared to the general population presenting with an acute UTI.

Graph 1. Difference in the resistance counts between LUTS patients and Acute UTI patients

figureau

References

  1. 1.

    Bryskier, A. (ed.). 2005. Antimicrobial agents: antibacterials and antifungals. ASM Press, Washington, DC.

  2. 2.

    Julian Davies , Dorothy Davies , Microbiol Mol Biol Rev. 2010 Sep; 74(3): 417–433. Origins and Evolution of Antibiotic Resistance

Disclosure:

Work supported by industry: no.

097

Transplantation of induced neural stem cells to promote the regeneration of anterior vaginal wall innervation

Dai, Y 1 ; Zhu, L 1 ; Zhang, G 1

1: Peking Union Medical College Hospital

Introduction and Hypothesis: Pelvic floor dysfunction is a kind of disease caused by pelvic floor tissue dysfunction. Pelvic floor nerve injury contributes to the pathogenic process of pelvic floor dysfunction. The objective is to appraise the effectiveness of transplantation of induced neural stem cells (NSC) from adipose derived mesenchymal stem cells (MSC).

Methods: MSC was induced into NSC by small molecules induction methods. MSC or NSC or MSC&NSC were transplanted into anterior vaginal wall innervation injure rat model by bilateral pudendal nerve blocking with or without absorbable cell scaffolds. Numbers of vaginal wall nerve fibers, neuronal markers and tensile properties were measured to find out the appropriate transplantation protocol

Results: Numbers of vaginal wall nerve fibers were significantly higher in groups with MSC transplantation on absorbable cell scaffolds compared to groups with MSC injection only at postoperation 1w, but almost the same between two groups at 3m. Numbers of vaginal wall nerve fibers were significantly higher in MSC&NSC group compared to MSC group or NSC group at postoperation 1w, but not at 1m and 3m. Neuronal markers expression showed almost the same pattern with nerve fiber counting. The maximum average load of vaginal wall strips were almost the same in different transplantation method or stem cell combination

Conclusions: MSC had repair effect on anterior vaginal nerve injury in rat models. Transplantation with absorbable cell scaffolds was better than transplantation by cell suspension liquid injection. Mesenchymal stem cells, neural stem cells and the mixed stem cells could produce the repair effect, and the repair effect of mixed cells might occur earlier. Tensile strength recovery of vaginal wall may require longer period after innervation improvement.

Keywords

Mesenchymal stem cells; neural stem cells; pelvic floor dysfunction; nerve injuries; nerve repair

Disclosure:

Work supported by industry: no.

098

Breastfeeding does not delay the pelvic floor recovery from pregnancy and labor

Weintraub, AY 1 ; Baumfeld, Y 1 ; Yohay, Z 1 ; Pardo, E 1 ; Glinter, H 1 ; Erenberg, M 1 ; Yahav, L 1 ; Yohay, D 1 ; SHOHAM, I 1

1: Department of Obstetrics and Gynecology, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel

Introduction: Pelvic floor dysfunction (PFD) symptoms are prevalent during pregnancy and are mostly reversible thereafter. The pelvic floor muscles and their surrounding connective tissue support are estrogen-responsive. Breastfeeding is a condition of estrogen deficiency. We hypothesized that in breastfeeding women there may be a slower spontaneous recovery of PFD symptoms following birth. We aimed to determine the impact of breastfeeding on PFD symptoms recovery.

Methods: We conducted a cohort study of women who gave birth at the Soroka University Medical Center, Beer-Sheva, Israel. Those who have consented completed the Pelvic Floor Distress Inventory-20 (PFDI-20), a condition specific questionnaire developed to measure quality-of-life and the extent of injury to the pelvic floor, after delivery and three months postpartum. Breastfeeding status was evaluated three months after delivery. Clinical and obstetrical characteristics were retrieved from the participants' medical records.

Results: A total of 119 women had completed the PFDI-20 after delivery and three months postpartum. We found a significant difference between PFD during pregnancy, and PFD three months postpartum (P<0.001). This difference remained consistent in all components of the PFDI-20: pelvic organ prolapse distress (P<0.001), colorectal and anal dysfunction (P<0.01) and urinary dysfunction (P<0.001). No significant difference was noted in the extent of recovery of PFD symptoms between women who did and did not breastfeed (P=0.59).

Conclusions: There is a clinical and statistically significant spontaneous recovery of PFD symptoms in the postpartum period. Breastfeeding does not delay the pelvic floor recovery from pregnancy and labor.

Disclosure:

Work supported by industry: no.

100

Comparing the incidence of post-surgical voiding difficulties across the three approaches of mid-urethral sling

Han, YJ 1 ; Han, HC 1

1: KK Women's and Children's Hospital, Singapore

Introduction: Voiding difficulty is a well-recognized complication of the surgical treatment of female stress urinary incontinence via mid-urethral slings. In this study we compare the incidence of voiding difficulty post-surgery across the three mid-urethral sling approaches (retropubic, transobturator and single incision).

Objective: To review all cases of mid-urethral slings done in our tertiary institution in a specific period, identify cases where patients had voiding difficulty post-surgery and compare the incidence across the different approaches.

Methods: Cases of mid-urethral sling procedures done over different periods were reviewed (Tension-free vaginal tape (TVT) 1999-2004, TVT-Obturator 2004- 2006, TVT-Exact 2012-2014, TVT Abbrevo 2011-2014, MiniArc 2014-2016). All of these cases were either done or directly supervised by a single senior consultant. Cases that had concomitant surgery e.g. for pelvic organ prolapse were excluded. Voiding difficulty post-surgery was defined as having a post void residual urine (PVRU) volume of >150mls and therefore requiring an indwelling urinary catheter after the second post-operative day (POD) where they would already have attempted two trials of spontaneous voiding. Cases that had voiding difficulty post-surgery were identified and analysed accordingly.

Results: The retropubic approach had the highest incidence of voiding difficulty post-surgery of 6.2% (17 out of 276 cases) while the transobturator approach had the lowest with 0.3% (1 out of 309 cases). The single incision approach had 2.1% (2 out of 94 cases). Two cases (0.7%) of TVT via the retropubic approach eventually required tape loosening, while another 2 (0.7%) required the tape to be cut, whereas none of the cases via the transobturator and single incision approach required tape loosening or division. The higher incidence of cases with the retropubic approach could possibly be due to this approach causing tighter tension on the urethra and hence a higher incidence of voiding difficulty. The transobturator approach is deployed at a wider angle which leads to lesser tension on the mid-urethra hence possibly resulting a lower incidence of voiding difficulty post-surgery.

Approach Sling Total number of cases Total number of cases with voiding difficulties Percentage (%) Combined (%)
Retropubic TVT 194 14 7.21 6.16
TVT - Exact 82 3 3.66
Transobturator TVT - Obturator 176 0 0 0.32
TVT - Abbrevo 133 1 0.75
Single incision Mini Arc 94 2 2.13 2.13

Conclusion: From this study we are more aware of that the incidence of voiding difficulties among the different types of mid-urethral slings in our setting, hence it enables us to counsel patients more effectively pre-operatively. We can also look to review the tension applied for the retropubic approach so as to possibly reduce the incidence of voiding difficulties post-surgery, but this could potentially lower the cure rate.

Disclosure:

Work supported by industry: no.

101

Utility and criticism of telemedicine in urogynecology: a prospective study

Balzarro, M 1 ; Rubilotta, E 1 ; Bassi, S 1 ; Processali, T 1 ; Pirozzi, M 1 ; Soldano, A 1 ; Trabacchin, N 1 ; Mancini, V 2 ; Costantini, E 3 ; Artibani, W 1

1: AOUI Verona, Dept. of Urology, University of Verona, Italy; 2: Dept. of Urology and renal transplantation, University of Foggia, Italy; 3: Santa Maria Hospital Terni, Dept. of Andrology and Urogynecology, University of Perugia, Italy

Introduction: telephone interview has been proposed as tool to follow-up patients after surgery[1]. Limits of these studies were: retrospectivity, no complicated cases, lack of comparison between telemedicine result and the objective evaluation in a clinic setting.

Objective: to prospectively compare telephone follow-up and in-clinic evaluation in a no selected population of women treated for stress urinary incontinence (SUI) and/or cystocele.

Methods: a prospective crossover blind comparative study was done involving women referring to our outpatient clinic from 12/2015 to 12/2017 following surgery for cystocele and/or SUI. First patients’ evaluation was done with a telephone interview, including a checklist of questions and validated questionnaires as The Patient Global Impression of Improvement (PGI-I), and Patient Perception of Bladder Condition (PPBC). At the end of the phone call all patient were scheduled for a conventional outpatient clinic the next 7-12 days. The in-clinic setting consisted with an interview, PGI-I, PPBC and the evaluation of objective outcomes. Success rate of MUS at the phone call was considered when patient referred no episode of SUI. Nevertheless, at the office evaluation this data was checked by stress test. Objective cure of cystocele was defined in case of asymptomatic POP with the midline anterior vaginal wall < POP-Q 2nd stage. Correspondence was obtained by Cohen test.

Results: 297 women have been enrolled in the study. Tables 1-2 report population’s characteristics. Surgical procedures (synthetic MUS; anterior vaginal wall repair; synthetic MUS associated to anterior vaginal wall repair) were performed in our Department from 2000 to 2017. In women with MUS 22% reported SUI recurrence at the phone interview. This group at in-clinic follow-up has shown a real SUI recurrence only in 13.5%, while part of the women misinterpreted urge urinary incontinence for IUS recurrence. No patient reported vaginal discharge nor the suspect of vaginal extrusion at telephonic and in-clinic follow-up. Patients with objective tape and/or mesh extrusion were 13. In the group treated for POP all women were able to refer by telephone interview a prolapse recurrence and if it was symptomatic. No statistical significant difference was found analyzing PGI-I and PPBC questionnaires when administered by telephone or in clinic follow-up. Statistical analysis showed a “substantial agreement” (K=0.782) between the two methods of follow-up (table 3).

Conclusions: telephonic follow-up was successful assessing an anterior vaginal POP recurrence due to the fact that all women experienced the cystocele before surgery. Moreover, in dry women the detection rate was comparable in both follow-up. Limit of telemedicine was the missed diagnosis of tape/mesh extrusion due to the lack of symptoms. Indeed, because none of these women was sexual active nor with tape infection, only an objective evaluation could lead to a correct diagnosis. Another limit was the overestimation of IUS recurrence due to misinterpretation of de-novo urge incontinence. The use of a dedicated checklist is suggested to focus the main clinical problems saving time. An appropriate pre and postoperatively counseling may limit part of these criticisms.

Reference: [1] Int Urogynecol J 27(5):787-790

Table 1. Population’s main performed procedures.

    n. Tot. Mean age
MUS TVT
TVT-O
18 %
82 %
22
100
122 66.8 ± 9.7
cystocele repair Fascial
Biomesh
Mesh
47.5 %
8.3 %
44.1 %
57
10
53
120 71.7 ± 9.2
MUS & cystocele repair TVT
TVT-O
Fascial
Biomesh
Mesh
34.5 %
65.4 %
85.4 %
12.7 %
1.8 %
19
36
47
7
1
55 72.7 ± 10.4

Table 2. Associated surgical procedures

  MUS + cystocele repair n= 55 (%) All participants n=297 (%)
Vaginal hysterectomy 31/55 (56.3) 31/297 (10.4)
McCall Culdoplasty 31/55 (56.3) 31/297 (10.4)
Posterior vaginal wall repair 17/55 (30.9) 17/297 (5.7)

Table 3. Outcomes at telephone and in-clinic follow-up

  Telephone follow-up In-clinic follow-up
% n % n
Stress urinary incontinence 22 39/177 13.5 24/177
Urge urinary incontinence 13.5 24/177 22.5 43/177
Urgency 14.6 26/177 15.2 27/177
Tape/mesh vaginal extrusion - 0/297 4.37 13/297
Vaginal bulging/POP 11.4 20/175 10.8 19/175
Dyspareunia 0.67 2/297 0.67 2/297
Voiding dysfunctions 1.01 3/297 1.01 3/297
PGI-I - mean (SD) 1.70 (1.23) 1.68 (1.27)
PPBC - mean (SD) 1.84 (1.22) 1.78 (1.18)

Disclosure:

Work supported by industry: no.

102

Incidence of dyspareunia following spontaneous vaginal childbirth: A systematic review and meta-analysis

Manresa, M 1 ; Pereda-Núñez, A 2 ; Bataller-Sánchez, E 3 ; Terré-Rull, C 4 ; Ismail, KM 5 ; Webb, SS 6

1: Hospital General de Granollers ; 2: Hospital General de Granollers; 3: Hospital Clinic i Provincial de Barcelona; 4: Universitat de Barcelona; 5: University of Birmingham; 6: Birmingham Women's and Children's NHS Foundation Trust

Introduction: Dyspareunia is one of the most frequent resultant long term morbidities after vaginal birth. However, the relationship between spontaneous vaginal delivery and dyspareunia is not well defined.

Objective: A systematic review to determine the incidence of dyspareunia related to intact perineum, first and second degree perineal trauma and episiotomy after spontaneous vaginal birth.

Method: Medline, EMBASE, CINAHL and MIDIRS databases were searched from inception to December 2017 using MeSH, and appropriate search terms to capture all studies using absorbable material and continuous technique for repair of at least one layer. Randomised Controlled Trials (RCTs) and Non-Randomised Studies (NRSs) were included. Case series and case reports were excluded.

Results: Only nine studies, involving 1443 women, satisfied inclusion criteria (6 RCT and 3 NRSs). Risk bias and the quality of included studies were assessed using validated methods. Quality assessment of included RCTs demonstrated that only 50% of the studies were well designed and reported. Within RCTs, observer and patient blinding was problematic in studies comparing continuous repair technique in all layers to only continuous technique used in the vagina. Regarding NRSs, all of the included studies met ≥50 quality assessment criteria, however only one reported the presence of any previous dyspareunia. None of the included studies reported data on first-degree perineal injury independently. For the time point of dyspareunia assessment less than 50% of the studies reported dyspareunia at 6-8 weeks or at 3 months. A third of the included studies reported dyspareunia at 6 months and only 11% at 12-18 months postnatal. We undertook a metanalysis of data from 1160 out of 1443 included women. Heterogeneity between studies regarding trauma classification, repair methods, parity, intrapartum factors and reporting mechanisms for dyspareunia, was the reason for our inability to pool data. Meta-analysis was complicated due to the diverse nature of the included studies that resulted in high heterogeneity (I2 ≥ 60). It demonstrated that the incidence on dyspareunia at 3 months for second degree-episiotomy, when continuous technique was applied in all layers, was 28% (n=96, 95%CI,16%-49%), while it increased to 30% (n=94, 95%CI,20%-48%) when only the vagina was sutured with continuous technique. Incidence of dyspareunia at 6 months for intact perineum was 10%(n=37)(95%CI,3%-36%).

Conclusions: This is the first systematic review for the incidence of dyspareunia following spontaneous vaginal childbirth. A significant number of included studies are limited by their sample sizes and methodological qualities. Heterogeneity between studies hindered our ability to undertake a comprehensive synthesis of the available evidence. Moreover, longer term follow-up of women following spontaneous vaginal birth and dyspareunia is lacking considering that it is this time period when women are more likely to resume their sexual activity returned to a pre-pregnancy state. Consequently, the incidence of longer-term dyspareunia for women after spontaneous childbirth remains unclear.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Boston Scientific, Promedon, Astellas).

103

Finite element model focused on stress distribution in the levator ani muscle during vaginal delivery – effects of fetal head molding

Krofta, L 1 ; Havelkova, L 2 ; Hyncik, L 2 ; Urbankova, I 1 ; Krcmar, M 1 ; Hympanova, L 1 ; Grohregin, K 3 ; Gojis, O 1 ; Feyereisl, J 1

1: Institute for the care of mother and child, Podolské nábřeží 157, 147 00 Praha, Czech Republic; 2: New Technologies – Research Centre, University of West Bohemia, Univerzitní 8, 306 14 Plzeň, Czech Republic; 3: Institute for the Care of Mother and Child, Charles University, Prague, Czech Republic

Introduction: A model of vaginal delivery is important for better understanding of stress applied to pelvic floor structures. However, many factors have not been yet included in modelling i.e. deformability of fetal head.

Objective: The purpose of this study was: (1) to simulate vaginal delivery using existing 3D computer model of female pelvic floor and considering the rigid fetal head; (2) to develop 3D model of deformable fetal head based on dynamic MRI data and to simulate the vaginal delivery; (3) to compare obtained results focused on stress distribution in musculus levator ani (MLA).

Methods: (1) The existing subject-specific 3D computer model of female pelvic floor and the rigid fetal head were used to simulate vaginal delivery. The model geometry is based on MRI data of a healthy nulliparous female (25 years; 3T, axial plane, slices 2 mm thick). It consists of main structures of pelvic floor. All bones are modelled by rigid bodies, the soft tissues by viscoelastic Ogden material. Material parameters were estimated by experiment (uniaxial mechanical test, female nulliparous pigs, removed during general anaesthesia) and by the least-square minimization method. The fetal head was considered in the optimal initial position – the left occipitoanterior. (2) The 3D model of fetal molding head was developed (figure 1). The dataset describing the head deformation during vaginal delivery was based on real-time dynamic MRI images of live childbirth (1T, mid-sagittal plane, slices 6 mm thick). For each frame, the fetal brain was outlined, the ellipse was fitted and changes of its minor and major diameters were measured. The geometry of fetal head was reconstructed from MRI (three-day old child; 3T, axial plane, slices 2 mm thick). The skull consists of seven bony parts (frontal, parietal, occipital on the right and left, and the bony rest) and sutures allowing their independent movability. For each bone, the individual trajectory was determined respecting head movements and molding recorded during dynamic MRI. The vaginal delivery was simulated using the original model of female pelvic floor and the new deformable fetal head. (3) The stress distribution in MLA during vaginal delivery was computed using presented simulations. Obtained results were compared and the effects of head molding were demonstrated.

Results: The final comparison of stress distribution in MLA for mentioned models is depicted in Table 1. It was found that the molding head decreases significantly the stress in MLA especially in the case of pubovisceral part.

Conclusions: Almost all virtual models considering the rigid fetal head offer satisfying results. Nevertheless, the stress decrease in floor structures using the molding one is significant. And thus, the molding head should always be implemented to get the precise results.

Table 1 Stress distribution in MLA (MPa) – comparison of models with rigid and molding head [mean value ± standard deviation].

Head descent [cm] Upper dorsal
MLA portion
(Iliococcygeus m.)
Left attachments anteromedial
MLA portion
(pubovisceral - puborectal m.)
Distal posteromedial
MLA portion
(puborectal m.)
Rigid head Molding head Rigid head Molding head Rigid head Molding head
-1 0.09 ± 3.89 0 0 0 0 0
0 0.13 ± 0.42 0.361 ± 0.40 0.01 ± 0.01 0 0 0
1 2.09 ± 12.49 0.74 ± 3.90 0.01 ± 0.69 0.01 ± 2.35 10.19 ± 8.98 10.67 ± 2.35
2 2.52 ± 6.13 1.04 ± 6.26 0.67 ± 0.82 0.46 ± 1.13 11.71 ± 10.32 13.21 ± 6.64
3 6.97 ± 7.73 4.04 ± 4.87 1.19 ± 1.53 0.74 ± 4.74 30.88 ± 30.41 15.02 ± 15.87
4 7.61 ± 10.89 13.23 ± 3.67 5.67 ± 6.09 3.10 ± 2.29 32.55 ± 20.51 14.44 ± 17.53
5 2.71 ± 3.38 12.09 ± 6.52 3.10 ± 2.68 5.79 ± 1.90 11.99 ± 4.13 5.21 ± 9.92
6 15.09 ± 19.83 13.15 ± 7.09 20.42 ± 15.79 17.57 ± 23.11 17.58 ± 8.99 8.72 ± 13.53
7 3.95 ± 10.464 1.74 ± 6.17 19.08 ± 20.89 18.67 ± 16.49 1.39 ± 1.21 1.52 ± 2.56
8 3.365 ± 5.146 1.58 ± 1.11 44.53 ± 34.95 35.59 ± 25.27 1.16 ± 0.34 0.76 ± 0.97
9 3.246 ± 3.548 1.56 ± 1.62 30.71 ± 14.25 21.21 ± 19.47 1.08 ± 0.51 0.02 ± 0.94
10 3.178 ±3.664 1.56 ± 1.58 6.12 ± 6.52 13.07 ± 11.02 1.01 ± 0.09 0.02 ± 0.88
figureav

Fig. 1. Color-coded view of the levator areas and deformable fetal head.

This study was supported by the international grant project SGS-2016-059 of the University of West Bohemia and Progres Q 34.

Disclosure:

Work supported by industry: no.

104

Experience of complications requiring surgical corrections among 982 cases of mid-urethral sling surgeries

Shin, DG1; Kim, HW1; Chung, MK2; Lee, SD2; Yoon, CS3; Choi, S4; Cho, WY5; Min, KS6; Lee, W7; Lee, JZ1

1: Pusan National University Hospital; 2: Pusan National University Yangsan Hospital; 3: BHS Han-seo Hospital; 4: Kosin University College of Medicine; 5: Dong-A University Hospital; 6: Inje University Busan Paik Hospital; 7: Dongnam Institute of Radiology and Medical Science

Introduction: Although mid-urethral sling surgery in female patients with stress urinary incontinence is proved as a simple and safe procedure with high treatment success rate, its complication rate is increasing with the growing number of the surgical cases.

Objective: The present study aims to investigate and assess the complications occurred from 982 cases of mid-urethral sling surgeries that require surgical correction or intervention.

Methods: Among 1,029 patients who underwent mid-urethral sling surgery (792 tension-free vaginal tape (TVT) cases and 237 transobturator tape (TOT) cases) in our department from 2002 to 2016, 982 patients who were able to be tracked by medical records were included in the study. The medical records of the 982 patients were reviewed to investigate the complications occurred from mid-urethral sling surgeries that required surgical correction or intervention. As well, the treatment options selected for each complication cases were assessed.

Results: The investigated complications which required surgical correction or intervention after mid-urethral sling surgery were as follows: 1 vessel injury (0.10%), 1 peri-obturator foramen abscess (0.10%), 3 vaginal erosions (0.31%), and 12 voiding difficulties (1.22%). In the case of vessel injury, the surrounding vessel of obturator artery was injured by the trocar insertion during TVT. The vessel injury was detected directly after the sling insertion and was managed by angioembolization. The peri-obturator foramen abscess occurred at 5 months after TOT, and it was managed by antibiotics along with aspiration of abscess via anterior vaginal wall without mesh removal. All vaginal erosion cases were treated by removing the exposed mesh along with repairing the incision of the anterior vaginal wall which was made for mesh removal. The 9 cases of voiding difficulty and the 3 cases with bladder irritation and urinary frequency which were drug-refractory were also treated by mesh removal. According to the medical records, there were no nerve injuries nor organ injuries.

Conclusions: The complications following the mid-urethral sling surgeries such as vessel injury, peri-obturator foramen abscess, vaginal erosion, and voiding difficulty could effectively be managed by intervention or mesh removal. The surgeons should always be aware of the possibility of severe complications and be prepared for valid management method for each complication.

Disclosure:

Work supported by industry: no.

105

Sexual disturbance in women with OAB

Lange, R 1 ; Frohnmeyer, DF 2 ; Hitschold, T 1 ; Naumann, G 3

1: Klinikum Worms; 2: Gyn. Obstet. Dept. St Josefs Hospital Wiesbaden; 3: Klinikum Erfurt

Introduction and aim of study: Urinary incontinence and sexual dysfunction are common diseases in women and are highly correlated (up to 50%) with impaired quality of life. Investigations of sexual disorders in urinary incontinence mostly concern urinary stress incontinence. Our aim was to investigate correlations ship between sexual problem and Overactive bladder in patients in a tertiary referred urogynaecology centre.

Material and methods: In this cohort study, we recruited 106 patients visited the urogynaecological outdoor clinic between December 2012 and January /2016.

65 women with urogynaecological symptoms who underwent a complete urodynamic investigation and had either a pure OAB or pure stress incontinence were included in the study, and 31 women who had a routine screening having no complains of LUTS or prolapse (controls). Sexual function was prospectively evaluated with a detailed 19-item questionnaire, the Female Sexual Function Index (FSFI), a validated German language version of the FSFI was used. The score of the questionnaire was min 2 and max 36 points.

On the basis of sensitivity and specificity analyses, a FSFI total score of <26 was considered to be a reliable cut-off score for differentiating women with and without sexual dysfunction.

Results: 100 questionnaires could be evaluated (94.3%) (USI n=34, OAB 35, controlled 31). Mean age was 56 years, there was no sign difference in age in the three groups. The median scores of the incontinence groups were significantly different to the controls (OAB 17.6 USI: 21.5 and controls 26.5). The differences between the OAB-patients and the controls could be found in all subscales of the questionnaire: Sexual interest, lubrication, orgasm, satisfaction, and dyspareunia, but not significant between USI and controls. Incontinence during intercourse was reported by 5% (1/21) of the OAB-group, but 25% (4/20) by the USI-group and none of the controls.

Conclusion: Sexual disorders are significant more often in women with OAB compared to non-incontinent controls or women with urinary stress incontinence. Although they do rarely report disturbance of intercourse directly by OAB-symptoms like urinary stress incontinence patients do by losing urine during sex. While this disturbs the self-confidence of stress incontinent women, in over active bladder it is not clear whether over active bladder symptoms disturb sexual function or vice versa, or whether there is a common cause for both.

Disclosure:

Work supported by industry: no.

106

Evaluation of pudendal nerve block in women with chronic pelvic pain (CPP)

Arunkalaivanan, A 1 ; Kaur, H 2

1: Waikiki Specialist Centre; 2: Waikiki Private Hospital

Introduction: Chronic Pelvic Pain(CPP) is a common condition in the women of reproductive age and the reported prevalence rate is up to 39%. It is not always possible to identify a single aetiology or definitive cure for chronic pelvic pain. In at least one-half of cases, there are one or more associated entities, such as endometriosis, or pelvic adhesions, irritable bowel syndrome, interstitial cystitis/bladder pain syndrome and pudendal neuralgia being present. Pudendal neuralgia is often misdiagnosed, inappropriately treated and observed in both men and women with a female predominance (60%)(1). Pudendal neuropathy is a common feature of syndromes such as dysfunctional voiding, non-obstructive urinary retention, chronic pelvic pain syndromes, and urinary and fecal incontinence. Pudendal neuropathy is a common feature of syndromes such as dysfunctional voiding, non-obstructive urinary retention, chronic pelvic pain syndromes, and urinary and fecal incontinence.

Objective: To determine the effect of pudendal nerve block (PNB) in women with CPP.

Methods We performed a chart review of 23 women with refractory chronic pelvic pain who received PNB between January and December 2017 with pudendal neuralgia, diagnosed based upon the Nantes’ criteria(2). PNB was performed in women with CPP who are refractory to conservative treatment for more than 2 months. Women with anatomical abnormality or infections were excluded. A transvaginal/transperineal PNB was performed targeting the pudendal trunk as it enters the lesser sciatic foramen, about 1cm inferior and medial to the attachment of the sacrospinous ligament to the ischial spine in lithotomy position. Using a 13cm/20gauge Rocket® pudendal block needle with a plastic guard, a total 20cc of 0.5% bupivacaine with 40mg Triamcinolone was injected in bilateral pudendal nerve. Vital signs were checked pre and post treatment status and 1hr after treatment. The change of subjective pain scale and reduction in pain medications, were analysed at post- block upto 12 months. All analyses were performed with SPSS v24.0.

Results:

Patient characteristics

Variable Values (n-23)
Age 21-55 (Mean37.05± SD8.4)
Parity 0-3 (Median 2)
Laparoscopy & Cystoscopy 18 (78.2%)
Hysteroscopy 1 (4.3%)
PNB alone 3 (13%)
Endometriosis 12 (52.1%)
Bladder Pain Syndrome 16 (69.5%)
Vulvodynia 3 (13%)
Adhesions 3 (13%)

PNB reported improvement in 21(91.3%) women with pelvic pain. Pre-op VAS 7-10 (9.1±0.8), Post-op VAS was 0-8 (1.6±2.2); 95% CI - 6.3-8.7; p value=0.00 (paired sample test). The resolution of lower urinary tract symptoms (LUTS) was observed in15/16 (93.75%) of women. The side effects included 2 women experienced single leg weakness that lasted for a maximum of 48 hrs, one patient experienced pins and needles in the legs making the total side effect rate to 13%. Duration of the injection lasted from 3 to 12 months. 3 (13%) received repeat injections.

Conclusions: In our study, PNB reduced chronic pelvic pain without severe side effect. The side effects of the weakness may be attributed to the lithotomy position for longer period with the concomitant procedures of cystoscopy & laparoscopy. The PNB is feasible, safe and also is associated with an overall improvement in CPP and LUTS.

References:

1.Pain Physician. 2016;19(3):E449-54.

2.Neurourol Urodyn. 2008;27(4):306-10.

Disclosure:

Work supported by industry: no.

107

Variations in reporting Bladder Pain Syndrome (BPS) /Interstitial Cystitis (IC) definitions, diagnostics, treatment and pathogenesis: a systematic review of national and international guidelines

Pape, J 1 ; Betschart, C 1 ; Falconi, G 2 ; Doumouchtsis, S 3

1: University Hospital Zurich; 2: San Bortolo Hospita; 3: Epsom & St Helier University Hospitals NHS Trust

Introduction: Interstitial Cystitis (IC) and the later introduced Bladder Pain Syndrome (BPS) are challenging and encompassing hypersensitivity disorders of the lower urinary tract (1). In order to serve clinical practice, a variety of international and national guidelines were introduced, reflecting the clinical issues in terms of nomenclature, definitions, diagnostics, pathoetiology and treatment. Though, a worldwide evidence-based consensus on the diagnosis and treatment of BPS is lacking.

Objective: The objective of the article is to review key guidelines at the time, focusing on the variations in nomenclature, diagnostics and treatment, compare their recommendations and grade them with the AGREE tool.

Methods: A systematic review was conducted to identify published international and national guidelines of IC/BPS. Literature searches were performed using PUBMED and CINAHL database from January 1, 1983 to December 1, 2017 using the following search strategy of AUA (2): “interstitial cystitis” OR “Painful bladder Syndrome”, OR “Bladder pain syndrome” OR IC/PBS OR “Chronic pelvic pain” AND “guideline” NOT “case reports” NOT “comment” NOT editorial NOT letter. Four authors assessed the methodological rigour and transparency of the different guidelines with the updated AGREE II (3). High quality guidelines are those with an overall score ≥70%.

Results: Nine guidelines were included into the analysis (Tabl. 1). Required symptoms congruent in all guidelines are: Pain, pressure, discomfort and frequency, urgency and nocturia. Pathogenesis is addressed comprehensively in the JUA, whereas other guidelines (ESSIC, AUA, CUA and RCOG) do not address this topic. Urine analysis is a prerequisite for all, cystoscopy for most, except the ICI-RS (consider) and AUA, and urodynamics is not part of the routine assessment in most guidelines. The treatment options are gradually recommended depending on severity of symptoms and in 6/9 guidelines presented in clinical algorithms (except ESSIC, SUG and AUG). The highest level of evidence and consensus is given for oral therapies with hydroxyzine, amitritpylin and pentosane polysulfate, whereas intravesical treatment evidences vary from 1b to 4 among different guidelines. Eight guidelines had an overall quality score of ≥ 50 % and three scored ≥70% (AUA, EAU, RCOG).

Guideline Year of publication Abbreviation
International Consultation on Incontinence-Research Society 2011 ICI-RS
European Society for the Study of IC/PBS 2008 ESSIC
European Association of Urology 2009 EAU
American Urological Association 2015 AUA
Canadian Urological Guideline 2016 CUA
Royal College of Obstetricians and Gynaecologists 2016 RCOG
Japanese Urological Association 2009 JUA
Spanish Urological Guideline Bladder Pain Syndrom 2015 SUG
Austrian Guideline Pelvic Pain Syndrom 2012 AUG

Table 1: BPS/IC Guidelines of national and international societies

Conclusions: The different guidelines are very congruent in symptoms reporting and quite congruent in diagnosis, and vary to a higher degree regarding treatment options. The psychosomatic aspect of the disease is mostly neglected. Regarding the complexity of the BPS and growing research, the guidelines will have to been updated for the next couple of years.

References:

  1. 1)

    J Urol, 1987; 140(1); 203-206

  2. 2)

    J Urol; 2011 185(6), 2162-2170

  3. 3)

    J Clin Epidemiol, 2012 65(5), 526-534

Disclosure:

Work supported by industry: no.

108

Is overactive bladder syndrome an early stage of bladder pain syndrome/interstitial cystitis?

Gamper, M 1 ; Walser, C 1 ; Späth, N 2 ; Moser, R 2 ; Viereck, V 1

1: Cantonal Hospital Frauenfeld; 2: IBR Inc., Institute for Biopharmaceutical Research

Introduction: Bladder pain syndrome/interstitial cystitis (BPS/IC) is a chronic bladder condition with unknown origin. The key symptom is “pain” accompanied by at least one other symptom such as a persistent urge to void or urinary frequency [1]. Only late stages with Hunner lesions and a small bladder capacity can be clearly identified by cystoscopy. Patients’ questionnaires suggest an early onset with milder and intermittent symptoms [2]. Certain patients with overactive bladder syndrome (OAB) or BPS/IC without Hunner lesion might actually have an early form of BPS/IC with Hunner lesion. The key symptom of OAB is “urinary urgency”, accompanied by frequency and nocturia, with or without incontinence [3], but without any pain.

Objective: This study aimed to investigate if there is molecular indication that BPS/IC with Hunner lesion is a late stage of a progressive disease and if subgroups of OAB and BPS/IC without Hunner lesion might be early forms. We hypothesized that gene expression levels in bladder biopsies and immunostaining of urothelial marker proteins associate with disease severity, and that there are gradual differences between healthy controls, OAB, BPS/IC without Hunner lesion and BPS/IC with Hunner lesion.

Methods: Bladder biopsies and bladder washings were collected from 12 patients with BPS/IC with Hunner lesion, 19 patients with BPS/IC without Hunner lesion, 12 patients with OAB and 10 healthy controls. The expression of 16 genes in bladder biopsies were quantified by real-time quantitative PCR, and umbrella cells in bladder washings were analyzed by immunohistochemistry with antibodies against urothelial proteins.

Results: Quantification of 14/16 gene expressions showed a gradual decrease or increase, respectively, from BPS/IC with Hunner lesion > BPS/IC without Hunner lesion > OAB > healthy controls. Decrease was found for mostly inflammatory genes, such as CCL18, CD20, CD79A, CHI3L1, CTLA4, FCER1G, IGH, IL8, LTF, MMP9 and PNOC, and increase was found for urothelial genes, such as KRT20, UPK1B and UPK3A. Umbrella cells were abundant in bladder washings of healthy controls, but not of patients with BPS/IC.

Conclusions: Our data suggest that certain patients with OAB and BPS/IC without Hunner lesion may have an early form of BPS/IC with Hunner lesion. Thus, in case of anticholinergic treatment failure, the patient may actually not have OAB, but BPS/IC without its characteristic subjective pain. Absence of umbrella cells in bladder washings may be an alternative, non-invasive method to diagnose BPS/IC. For validation of this novel approach, more studies including more patients and various bladder conditions are required.

References:

[1] Eur Urol (2008) 53: 60-67.

[2] Transl Androl Urol (2015) 4: 605-610.

[3] Neurourol Urodyn (2010) 29: 4-20.

Disclosure:

Work supported by industry: yes, by Astellas European Foundation. A consultant, employee (part time or full time) or shareholder is among the authors (Volker Viereck: Astellas Pharma AG Switzerland, Advisory Board).

109

Pelvic floor morphology in female chimpanzees

Abdool, Z 1 ; Koeppel, K 1 ; Dietz, HP 2

1: University of Pretoria; 2: University of Sydney

Introduction: Topographical pelvic floor anatomy plays a significant role in maintaining the structural integrity of the pelvic floor (1). Disruption of puborectalis muscle from its insertion on the pubic symphysis as a consequence of maternal vaginal childbirth is an established risk factor for the development of pelvic floor dysfunction (2).Nonhuman primates have relatively easy birthing which is thought to be largely due to the favourable bony pelvic floor anatomy as compared to humans. In addition to human maternal birth trauma, both skeletal and muscular adaptations have been postulated as possible reasons for the development of pelvic floor dysfunction in humans.

Objective: This study evaluated the topographical anatomy of nonhuman primates i.e. nulliparous female chimpanzees using four dimensional (4D) transperineal pelvic floor ultrasound (TPUS).

Methods: This prospective study included 16 nulliparous female chimpanzees (Pan troglodytes) from a chimpanzee sanctuary. As part of a routine health check and medical research, 4D TPUS was performed. Volumes were acquired at rest and prone, with the animal anesthetized without muscle relaxant agents. A GE Voluson S6 BT16 system with RAB 6-RS 2-8MHz was used, and offline analysis was performed using 4D View software (GE, Kretztechnik, Austria). We analysed the appearance of the pelvic floor musculature, mean hiatal distance and levator hiatal area at rest, using standard protocols for pelvic floor ultrasound in humans(3). Ethical approval was obtained from the University of Pretoria Animal Ethics Committee.

figureaw

Figure: Pelvic floor appearances in primate nullipara at rest. Panel A shows the midsagittal plane, B a rendered volume representation of the levator hiatus, and C a tomographic representation of the equivalent to the human puborectalis muscle.

Results: The mean age was 16 years (13-34 years) and mean BMI 48.8 (36-67). One dataset was excluded due to poor image quality. The appearance of the nulliparous primate pelvic floor is shown in the midsagittal plane in Figure 1A, the levator hiatus in 1B and tomographic axial plane imaging of the levator ani muscle complex in Figure 1C. The mean levator hiatal anteroposterior distance and hiatal area (n=15) at rest were 5.24 (4.12- 6.5) cm and 20.91 (13.99-33.11) cm2 respectively. The anorectal angle seemed to be wider than in human females.

Conclusion: Despite significant differences in pelvic bony anatomy, the gross appearance of the levator-ani muscle complex bears some resemblance to that of human females. There seems to be an equivalent to the puborectalis muscle, and an intact muscle insertion was usually identifiable, as it is in human nulliparae. Numerical comparisons are difficult as assessments were conducted under anaesthesia. The posterior compartment appears to be less similar in appearances compared to homo sapiens. While there are internal and external anal sphincter equivalents, the anal canal may be relatively wider, and the external sphincter may be thinner than in humans. Clinical correlation with cadaveric dissection will allow for a more extensive analysis.

References:

1. Obstet Gynecol 2007;109:295–302.

2. Br J Obstet Gynaecol 2008;115:979–984.

3. Clin Obstet Gynecol 2017; 60: 58–81

Disclosure:

Work supported by industry: yes, by GE Healthcare. A consultant, employee (part time or full time) or shareholder is among the authors (GE Healthcare).

110

Vaginal axis on MRI after prolapse surgery - A randomized controlled trial

Juliato, C 1 ; Santos JR, L 2 ; Castro, E 2

1: University of Campinas; 2: University of Campinas - UNICAMP

Introduction: pelvic organ prolapse (POP) is a major health problem worldwide and patients often suffer with surgical failures and reoperations. Reestablishing normal pelvic anatomy may be key to improving surgical outcomes. Vaginal surgery has been shown to be less invasive and quicker, but still presents worse results when compared to the abdominal route, especially for the vaginal anterior wall and apex correction, and that may be due to anatomy distortion caused by sacrospinous approach, regarding mostly the postoperative vaginal axis.

Objective: to determine the postoperative vaginal axis comparing sacrospinous fixation with anterior mesh (SSF) to abdominal sacrocolpopexy with mesh (ASC), in a randomized controlled sample, and its correlation with vaginal and urinary symptoms, physical examination and quality of life measures.

Methods: 60 patients with advanced prolapse randomized to SSF or ASC in a pilot study were recruited with a medium 24-month follow-up to do a postoperative magnetic resonance (MRI). Vaginal axis was determined based on recent literature standards using the pelvic image correction (PICS) line, and divided in normal or abnormal, following percentile distribution, regarding the 2 vaginal portions identified in the MRI – inferior and superior. All subjects filled quality of life validated questionnaires regarding pelvic and urinary symptoms, sex life, and overall satisfaction, and were submitted to standard pelvic organ prolapse quantification (POP-Q) evaluation. Statistical comparison was made using chi-square and Student´s-T tests with significance level of 0,05.

Results: 40 patients were submitted to postoperative MRI, with 20 patients from each group. Mean superior vaginal axis relative to PICS line was 85,86º in the SSF group versus 87,1º in the ASC group (p 0,06) whereas mean inferior axis was 72,5º versus 79,7º (p 0,31). Percentile distribution analysis showed an inferior deviated axis in 60% of SSF versus 35% of ASC women (OR 2,7 CI 0,7-10,4 p 0,06). As for the superior axis, 50% of women in the SSF and 40% in the ASC groups had abnormal values (OR 1,48 CI 0,4-5,4 p 0,2). When we grouped the sample using vaginal axis as the main parameter, and compared normal versus abnormal axes in both vaginal portions, there were no statistical significant differences regarding: main postoperative POP-Q points, overactive bladder scores, sex life scores, general quality of life assessment or patient satisfaction. Patients with an abnormal vaginal axis in its superior portion showed statistically worse mean scores for the stress incontinence questionnaire (ICIQ-SF): 1,45 versus 4,11 (p 0,02).

Conclusions: SSF and ASC showed no statistical difference in vaginal axis postoperative orientation, but both techniques resulted in deviation of vaginal anatomy in at least 35 % of patients, with a tendency of greater discrepancy in the SSF group. Vaginal axis distortion showed statistical worsening of stress urinary symptoms in our sample. More studies with larger samples could help defining vaginal axis and its role in POP surgery success.

figureax

Figure 1 – sagittal view on pelvic MRI. PICS: pelvic imaging correction system. PCL: pubococcigeal line. Vaginal axis: line drown through the vaginal walls, divided in two sections (superior and inferior vaginal axes)

Disclosure:

Work supported by industry: no.

111

First-line treatment of pelvic organ prolapse

Kantharooban Umachanger, J1; Marcussen, M1; Bøgild, H2; Kjærgaard, N3; Glavind, K3

1: Aalborg University Hospital; 2: Unit of Epidemiology and Biostatistics, Aalborg University Hospital; 3: Department of gynecology Aalborg University Hospital

Introduction: The aim of treatment of pelvic organ prolapse (POP) is symptom relief. There are three treatment options: “watchful waiting”, pessary, or surgery. “Watchful waiting” includes pelvic floor muscle training, weight loss, vaginal oestrogen, and counselling.

Objective: The primary aim of this study was to investigate the distribution of first-line treatment of POP in women referred to a University Hospital and characteristics associated with treatment choice. A secondary aim was to investigate the rate and cause of discontinuation of pessary treatment within three months.

Methods: This was a retrospective chart review of women referred with POP between 01.01.14 and 31.12.15. Baseline demographic data, previous medical history, and clinical characteristics include age (<65/≥65 years), body mass index (BMI) (<25/≥25), previous use of pessary, total number of births (0-1/≥2), vaginal births (0-1/≥2), previous caesarean sections (C-sections), previous hysterectomy, previous prolapse surgery, previous incontinence surgery, smoking, menopause, sexual status, and pelvic organ prolapse quantification (POP-Q) stage in the three vaginal compartments (anterior, apical, posterior). First-line treatment was noted as either “watchful waiting”, pessary, or surgery. Women treated with pessary were seen after three-months. Extra visits, reason for discontinuation, and secondary choice of treatment were noted. Associations between the dependent and independent variables were assessed using Chi-squared test. Multinomial logistic regression was performed with first-line treatments as dependent variable. Binary logistic regression was performed with the dependent variable as continued or discontinued pessary use. Two-sided P-value <0.05 was considered statistically significant.

Results: The study included 794 women. First-line choice was surgery in 50%, watchful waiting in 33% and pessary in 17%. An association was found between the first-line treatment and age, previous use of pessary, previous prolapse surgery, menopause, predominant compartment, and POP-Q stage. Characteristics associated with choosing surgery instead of pessary were age < 65 years, previous prolapse surgery, prolapse in anterior or posterior compartment or POP-Q stage ≥2. Characteristics associated with choosing watchful waiting instead of pessary are women younger than 65 and a prolapse in the posterior compartment. A total of 33 % (43/130) discontinued pessary treatment at or before their three-months follow-up visit. An association was found between discontinuation and hysterectomy, previous pelvic surgery, and extra visits. The three most common reasons to discontinue pessary were expulsion of the pessary (37.2 %), discomfort or pain (20.9 %), and no effect (11.6 %). After discontinuation of pessary 63.6 % chose surgery and 36.4 % watchful waiting.

Conclusion: This study shows that 50 % of patients referred with POP to a University Hospital are treated with conservative treatment and 50% with surgery. More patients could thus be treated outside of the University Hospital after proper education of primary doctors. Women are more likely to prefer surgery to pessary if they are <65 years, have previous prolapse surgery, have prolapse in the anterior or posterior compartment, and/or have a POP-Q stage ≥2. Characteristics associated with discontinuation of pessary treatment are age <65 years, previous pelvic surgery, and having extra visits. Information about adjustment of the pessary size and type is important.

Disclosure:

Work supported by industry: no.

112

The impact of obesity on operative complications and outcome after sacrocolpopexy: A systematic review and meta-analysis

Miao, Y 1 ; Wen, J 2 ; Wu, J 2 ; Zhao, Z 2

1: West China Second University Hospital, Sichuan University; 2: West China School of Preclinical and Forensic Medicine, Sichuan University

Introduction: For pelvic organ prolapse, surgery is required by many women with obesity and sacrocolpopexy is considered an indicted method to correct prolapse of the anterior and/or apical vaginal-wall compartments. However, these epidemiological studies have never been formally summarized.

Objective: Review available evidence on the existing evidence to explore the effects of obesity in affecting the surgical complications and effectiveness of sacrocolpopexy of women.

Methods: A systematic literature search was carried out for English-language literature in Pubmed, Medline (Ovid), Embase database (last search was performed October 20, 2017). Statistical analysis was performed using Revman 5.2.

Results: A total of 6650 patients in 9 studies were included in this meta-analysis. The results suggested that there was no significant difference in non-obese women and obese women in terms of reoperation rate (OR, 0.87: 95%CI, 0.64–1.18, p=0.36), POP-Q measurements(OR, 1.21: 95%CI, 0.83–1.75, p=0.32), transfusion rate(OR, 1.21: 95% CI, 0.75–1.95, p=0.44), erosion rate(OR, 0.63: 95% CI, 0.33–1.22, p=0.17), overall surgical complications rate(OR, 0.70: 95% CI, 0.48–1.02, p=0.07) and the length of hospital stay (mean difference, 0.06 day; 95% CI, 0.19-0.31 day). Additionally, the rate of bladder injury, ileus and urinary incontinence in non-obese women and obese women also showed no significant difference. However, non-obese women were associated with a lower conversion rate (OR, 0.25; 95% CI, 0.13–0.48, p<0.0001), lower infection complications rate (OR=0.46, 95%CI=0.32-0.66, p<0.0001), lower operative duration (mean difference, 16.75 minutes; 95% CI, 8.42-25.07 minutes) and lower estimated blood loss (mean difference, 20.56 ml; 95% CI, 7.08-34.04 ml). In subgroup analyses, significant difference was observed only in the analysis of the overall surgical complications rate. The pooled data revealed that the overall surgical complications rate was lower in the non-obese women group than that in the obese women group when undergoing laparoscopic sacrocolpopexy (OR, 0.62: 95% CI, 0.40–0.96, p=0.03).

Conclusions: Obese women have similar surgical complications and effectiveness of sacrocolpopexy with non-obese women, except the conversion rate and infection complications. Non-obese women were associated with a lower conversion rate and lower infection complications. Therefore, improved care for obese patients in perioperative period is needed. Regarding of some limitations for this study, the results should be explained with great caution, and more large-scale studies with different environmental backgrounds are urgently needed.

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113

Performance and outcome of sacrospinous ligament fixation: A 5-year review

Bhutia, K 1 ; Lim, T 2 ; Han, HC 1

1: KK Women's & Children's Hospital; 2: School of Medicine, University of New South Wales, Australia

Introduction: Pelvic organ prolapse (POP) is a common problem in middle-aged and elderly women. In a population like Singapore with aging population and more women reporting late with severe grade prolapse, recurrence rate of pelvic organ prolapse post-native tissue repair is high. Surgeons seek more durable surgical intervention with the use of graft material to augment prolapse repair. However, due to the recent US Food and Drug Administration warning about mesh-related complications, sacrospinous ligament fixation (SSF) as a traditional vaginal procedure plays an important role again.

Objective: The study aims to assess efficacy, intra- and post-operative complications and long term follow up outcomes in women with unilateral SSF.

Methods: A retrospective study of 330 patients who underwent vaginal unilateral SSF between July 2007 and June 2012 in a single tertiary care centre, either operated or supervised by a single surgeon. These women were followed up at 6 months and then yearly up to 5 years. Case records of these patients were retrieved. Phone consultation was conducted for defaulted patients. Objective cure rate was defined as anatomical criteria of Baden-Walker less than or equal to grade 1. Subjective cure rate was defined as the absence of lump at introitus and overall patient satisfaction on the outcome of the procedure.

Results: The mean age was 62.2 years. Average blood loss was 44.8 ml ± 42.2 (ranging 5-300 ml). Two patients had bladder perforation (0.6%) and 5 patients had rectal perforation (1.5%). Post-operatively, complications like urinary tract infection (1.2%), fever (6.3%), buttock pain (6.3%), and thigh discomfort (1.8%) were noted. Dyspareunia was reported by 1 patient at 1-year follow up and by 2 patients in 2-year follow up. Sixteen (4.8%) had voiding difficulty, out of which 9 patients had a concomitant mid-urethral sling procedure. Eight (2.4%) patients were readmitted for a repeat procedure - 2 underwent total prolift for recurrent vault prolapse and cystocele, 3 had anterior prolift for cystocele while 3 underwent prolene thread excision, of which one had a concomitant Fenton’s repair following a complain of dyspareunia. The subjective and objective cure rates respectively were 99.7% and 99.7% at 6 months, 98.8% and 98% at 1 year, 99.1% and 98.6% at 2 years, 100% and 97.4% at 3 years and 99.4% and 97% at 4 years. At 5 years, 135 (40.9%) patients were available for follow up. A total of 145 (43.9%) defaulted patients were followed up with phone consultation. Eleven (3.4%) patients had died due to various systemic diseases. A further 39 (11.8%) defaulted patients were uncontactable. The subjective and objective cure rates at 5 years were 99.3% (n=280, including follow up with phone consultations) and 95.6% (n=135) respectively. Eight (5.9%) patients had recurrent grade 2 cystocele and 1 (0.7%) patient had grade 3 rectocele.The ove rall satisfaction rate at 5 years follow up was 97.8%.

Conclusions: SSF is an excellent choice of procedure for suspension of the vaginal apex in vaginal vault prolapse and severe uterovaginal prolapse, with a high success and minimal complication rates.

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114

Surgical treatment of primary apical prolapse; A national overview

Husby, KR 1 ; Lose, G 1 ; Klarskov, N 1

1: Department of Obstetrics and Gynecology, Herlev and Gentofte University Hospital

Introduction: Pelvic organ prolapse is a common diagnosis affecting millions of women worldwide. There is no consensus on which operation technique is ideal to treat apical prolapse. A range of surgical techniques exist with vaginal hysterectomy with suspension of the vaginal cuff as the most frequently used. However, the popularity of uterus-preserving techniques is increasing.

Objective: The aim of this study was to illustrate the development of used operation techniques when treating primary apical prolapse in Denmark.

Methods: Data was obtained from Danish Urogynecological Database and included women with primary prolapse surgery in the apical compartment operated in Denmark year 2010-2016. Women who were previously operated for prolapse in at least one compartment, operated for incontinence or hysterectomized were excluded. In Denmark the National Board of Health categorized urogynecological procedures in three categories; general procedures which all gynecological departments are certified to perform, regional procedures which one or few departments are certified to perform in each region, and highly specialized procedures which few department are certified to perform in the entire country. Vaginal surgery with native tissue repair for utero-vaginal prolapse is categorized as a general procedure. Hospitals were divided into four groups according to level of specialization of urogynecological procedures: 1) Highly specialized urogynecological departments, 2) Regional urogynecological depertments if they had at least one urogynecological function as highly specialized or regional function respectively, 3) General gynecological department if they had neither highly specialized nor regional function, and 4) Private Hospital.

Results: The number of vaginal hysterectomies has decreased from 2010 to 2016. Alongside the number of uterus-preserving operations has increased (fig. 1). The proportion of uterus-preserving techniques versus vaginal hysterectomy differed substantially between different types of hospitals. For the departments with high urogynecological specialization the part of uterus-preserving techniques was considerably increasing (p < 0.0001), with nearly 90 % of all operations in the apical compartment performed as uterus-preserving in 2016. For departments with regional urogynecological function the part of uterus-preserving techniques was likewise increasing (p < 0.0001) to almost 40 %, while the part was decreasing for departments with general gynecological function (p < 0.0001) to below 35 %. The number of patients operated at private hospitals were low and the part of uterus-preserving operations was varying, however, the trend was going towards less uterus-preserving operations (p = 0.01). Three of the four highly specialized departments preferred Manchester Fothergill procedure while one preferred sacrospinous ligament fixation.

Conclusions: The proportion of uterus-preserving techniques versus vaginal hysterectomy increased through the years 2010-2016. However, the proportion varied substantially between different hospital types. It is notable that less specialized hospitals were more likely to perform vaginal hysterectomy than specialized hospitals even though the uterus-preserving technique is less complicated. At the four hospitals with highly specialized urogynecological function, the choice of uterus-preserving technique varied considerably.

Culture, education, and preferences of the surgeon seem to influence choice of operation technique rather than evidence and economics. Further research is crucial to determine which operation is best practice when treating women with apical prolapse.

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115

Clinical management of 110 cases of polypropylene mesh and sling exposure after pelvic floor surgery

Niu, K 1 ; Lu, Y 1

1: The First Affiliated Hospital Of Chinese PLA General Hospital

Introduction: The management of polypropylene (PP) mesh exposure is challenging due to lack of a consensus for treatment. The difficulties in mesh management result from the diversity of symptoms, and the anatomically complex sites of mesh placement that can make it hard to remove totally. This may complicate healing due to continued presence of mesh as a foreign body. We identified 110 cases of mesh exposure after reconstructive pelvic surgery (RPS) that we have managed in the last 15 years.

Objective: To explore the clinical management and outcomes of mesh and sling exposure in our hospital from 2002-2017.

Method: We analyzed 110 cases of mesh and sling exposure after RPS from our hospital identified, who presented between Jan 2002 to Oct 2017. Mesh and sling exposures identified in the outpatient clinic and categorized and managed according to the ICS-IUGA classification about category, time, site (CTS) of mesh complication. Outpatient management included observation, topical estrogen use and mesh removal. Management in hospital included surgical removal of exposed mesh and repair of the resulting defects under the anesthesia. 74 cases (67%) were managed in the outpatient setting, and 36 cases (33%) required inpatient management. Follow-up was consecutively performed from1 month to 15 years,. Objective outcome included the surgeon’s assessment of the healing state of the vaginal mucosa. Subjective outcome was evaluated with global impression of improvement questionnaire (GPI-I).

Results: One hundred and ten patients with mesh exposure were classified according to the different RPS they underwent. There were 95 cases from transvaginal mesh surgery (TVM), 5 cases from anti-SUI sling surgery, and 10 cases from sacrocolpopxy (ASC).The outpatient group healed at an average of 3 months. Of the 36 patients who required Inpatient management, 21(72.4%) healed completely at an average of 7 days after one surgery. The remaining 8 cases required either 2 or 3 surgeries or conservative management. The GPI-I in the outpatient group was score 5 in 65 cases (88%) and 4 in 9 cases (12%), respectively. In the inpatient surgery group, GPI-I was score 5 in 30 cases (83%), and 4 in 6 cases (17%), respectively.

Conclusion: Among patients with mesh exposure after mesh-augmented RPS, 2/3 of patients with a CTS classification 1-3 can be managed in the office and remaining 1/3 with CTS 4-6 need operation under anesthesia in hospital. If the mesh and sling exposure could be scientifically classified, according to the size ,site and accompany symptoms, as well as pain, most of the mesh exposures complication could be resolved. The overall satisfaction of the patients to the operation has been largely improved.

Reference:

1. Committee Opinion No. 694: Management of Mesh and Graft Complications in Gynecologic Surgery. Obstet Gynecol. 2017,129(4):e102-e108.

2. Ke Niu,Yongxian Lu,Jiewen Shen,et al.Risk Factors for Mesh Exposure after Transvaginal Mesh surgery. ChinMedJ,2016,Aug 5;129(15): 1795-1799.

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116

MRI analysis of the musculo-fascial component of pelvic floor in women before planned vaginal reconstruction procedure for symptomatic pelvic organ prolapse

Nemec, M1; Horcicka, L2

1: Hospital in Frydek-Mistek; 2: GONA

Introduction: Pelvic organ prolapse is a common bothering situation in many women. Right examination and operation technique decision is a crucial step to help woman from these bothering.

Objective: The aim of the study is to analyse the musculo-fascial component of the pelvic floor in symptomatic women with pelvic organ prolapse before planned vaginal reconstruction using synthetic vaginal mesh.

Methods: The observational study carried out between 2008-2015 involved 285 female volunteers; 6 were nulliparous, all others had given birth vaginally at least once. All patients had undergone a comprehensive urogynaecology examination supplemented by magnetic resonance imaging (MRI) of the pelvic floor prior to the planned reconstructive vaginal operation. The following components of the pelvic floor were assessed: Levator ani muscle (MLA), endopelvic fascia (EF) and sacrouterine ligaments(SUL). Levator ani and endopelvic fascia were evaluated at two levels. The first level corresponded to the puborectalis muscle - evaluation of MRI trauma stage and avulsion. The second level corresponded to the iliococcygeus muscle - only avulsion injury to the muscle was evaluated.

Results: Normal appearance of musculus puborectalis (level1) was found in 25 (8.8%) women. Minor MRI trauma was reported in 117 (41.1%) women, major MRI trauma was reported in 143 (50.2%) women. Avulsion of the muscle was captured in 85 (29.8%) cases at level 1 and in 165 (57.9%) cases in level 2. Preserved architecture of the EF was found in 99 (34.7%) of the cases in level 1 and only 47 (16.5%) cases in level 2. Sacrouterine ligaments showed normal morphology in 100 (35.1%) cases.

Conclusion: Defects of musculofascial component of the pelvic floor is found frequently in women with symptomatic POP. Often a combination of defects MLA, EF and SUL is found. These complex pelvic floor defects require careful urogynaecological examination. MRI analysis of the musculo-fascial component of the pelvic floor can be a useful adjunct in complex cases where surgical intervention is required, helping to choose correct method of surgery and minimize the likelihood of recurrence of the descent.

Schematic MRI scans in level 1

figureaz

Schematic MRI scans in level 2

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117

Survey of IUGA members on the use of topical oestrogen in the pessary management of pelvic organ prolapse

Taithongchai, A 1 ; Latthe, P 2 ; Hagen, S 3 ; Sultan, A 1 ; Thakar, R 1

1: Croydon University Hospital; 2: Birmingham Women's NHS Foundation Trust; 3: Glasgow Caledonian University

Introduction: Pessaries have been used to conservatively management female pelvic organ prolapse (POP) by clinicians for centuries. They are an effective and simple treatment option, with reported improvements in vaginal, bowel, urinary and quality of life scores on validated questionnaires. Failure of pessary retention and complications can cause women to discontinue their pessary use, even if they had symptomatic relief. The reported complication rates vary widely across studies, ranging from 12%-56%1. Few studies have evaluated the potential benefits of vaginal oestrogen with pessaries, with conflicting results. One study has shown that vaginal oestrogen will reduce the likelihood of pessary discontinuation but not prevent erosions or bleeding2, whereas another study has shown a trend towards higher complications amongst non-oestrogen users3. Currently there is inadequate evidence from trials to say whether oestrogen will reduce complications associated with pessary use.

Objective: To ascertain the global pattern of prescribing of vaginal oestrogen for women using pessaries for POP and assess acceptability of a proposed randomised controlled trial of topical oestrogen with pessaries for POP.

Methods: A questionnaire containing 11 questions was devised by the authors and sent via email to all IUGA members, with a reminder email three weeks later. The survey was closed after a further two weeks and responses were analysed on Excel.

Results: A total of 354 responses were obtained (12.7% response rate): 53% from urogynaecologists or subspecialists and 41% from gynaecologists with an interest in urogynaecology from at least 46 different countries. Most respondents (95%) felt vaginal oestrogen is beneficial in post-menopausal women with a pessary for POP. Just over half (53%) reported that they always prescribe vaginal oestrogen when fitting a pessary and 42% sometimes do. Vaginal oestrogen was prescribed for pessary related complications by 90% (Figure 1). In terms of the regime, 85% prescribed daily oestrogen for two weeks followed by twice weekly thereafter, and 75% prescribed a cream preparation. There was variation in the reported frequency of pessary change; the most common was 3-monthly change for hospital (53%) and self-managed patients (46%). Over half (58%) would be willing to recruit to a randomised controlled trial of the effectiveness of vaginal oestrogen versus placebo in reducing pessary-related complications. Similarly, 56% would be willing to recruit to a trial of vaginal oestrogen versus no oestrogen.

Conclusions: Despite a lack of evidence of effectiveness, nearly all clinicians responding believed that local oestrogens are beneficial to post-menopausal women using a pessary for prolapse. Correspondingly, 90% of respondents use local oestrogens routinely to treat and prevent pessary-related complications. However, there is no evidence of the impact of this practice on women’s quality of life, symptoms of prolapse or pessary-related complications. There is a need for a randomised controlled trial to produce the evidence to help health care providers advise women with pessaries about using local oestrogen; this has also been highlighted in the James Lind Alliance top ten research priorities.

References: 1. Int J Gynaecol Obstet. 2011;114(1):56-9 2.Int Urogynecol J. 2016;27(9):1423–1429.3. Post Reproductive Health 2015;21(4) 141–145

Figure 1

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118

Does bilateral sacrospinous ligament fixation amplify anterior compartment prolapse? A case series

Henn, E 1 ; Honing, T 1

1: University of the Free State

Introduction: Pelvic organ prolapse (POP) in adult women poses a significant burden of disease. There has been a reluctance and, in some countries, a total ban on the use of vaginal mesh for POP. Vaginal sacrospinous fixation (SSF) is a recognized surgical technique for correction of apical compartment prolapse. Bilateral SSF (colpopexy or hysteropexy) however, has the benefit of creating a more symmetrical vaginal reconstruction, with additional apical vaginal support.

Objective: We have observed a possible high incidence of anterior prolapse after bilateral SSF procedures. The objective of this research was to evaluated the validity of this perception.

Methods: A retrospective review of bilateral SSF cases between January 2008 and June 2012 in a tertiary referral hospital was performed. Cases were identified from a database and all eligible (bilateral SSF) cases were assessed for inclusion. Demographic data, symptoms and pelvic organ prolapse staging pre- and post-SSF were collected. Cases with incomplete data or with follow up less than 12 months were excluded. A successful compartmental repair was defined as less than an IUGA/ICS POP-Q stage 2. Summary statistics included frequencies and percentages for categorical data, and medians or means for continuous data. The pre- and post-treatment comparisons were done using McNemar’s test for paired data.

Results: From a possible 68 cases, 64 patients met the required inclusion criteria (51 bilateral sacrospinous hysteropexy procedures, and 13 bilateral sacrospinous colpopexy procedures). The clinical demographics are presented in Table 1. The median follow up period was 13 months, the mean age 59 and BMI 31.2. Apical prolapse was successfully repaired by bilateral SSF in 50/64 patients (78%). All categories of symptoms improved post-operatively, with the greatest improvement (80%) (p= < 0.001), in the vaginal bulge category. There were no new cases of dyspareunia or of obstructed defecation. Of the 25 pre-operative ≥ Stage 2 anterior compartment prolapse, 23 underwent an anterior colporrhaphy at the time of the SSF procedure. In 2 cases the anterior descent was primarily reflective of a level 1 defect and was adequately corrected with the SSF. Forty-one patients (64%) had significant (stage 2 or more) anterior vaginal prolapse post-operatively, of which 28 (68%) were new onset anterior vaginal prolapse, and 13 (32%) were recurrent. 24 Were asymptomatic and managed conservatively, while 17 required further surgery. Median time to becoming symptomatic was 7 months.

Conclusions: Bilateral sacrospinous fixation is an effective procedure for correction of apical prolapse (78% success), but is significantly associated with anterior vaginal prolapse. This should be included in the pre-operative counselling.

Table 1. Comparison of pre- and post-operative prolapse and symptoms

  CATEGORY PRE-OP n=64 (%) POST-OP n=64 (%) P-value
PELVIC ORGAN PROLAPSE PELVIC ORGAN PROLAPSE (POP-Q) stages
Anterior compartment    0.0217
None 14 (22%) 12 (19%)  
I 25 (39%) 11 (17%)  
II 12 (19%) 22 (34%)  
III 13 (20%) 19 (30%)  
Apical compartment    <0.0001
None 0 39 (61%)  
I 0 11 (17%)  
II 14 (22%) 9 (14%)  
III 38 (59%) 5 (8%)  
IV 12 (19%) 0  
Posterior compartment    <0.0001
None 8 52 (81%)  
I 13 5 (8%)  
II 22 6 (9%)  
III 21 1 (2%)  
SYMPTOMS SYMPTOMS
Vaginal bulge 64 (100%) 13 (20%) <0.0001
UUI 35 (55%) 12 (19%) <0.0001
Constipation/ODS 20 (31%) 12 (19%) 0.0078
Chronic pelvic pain 21 (33%) 12 (19%) 0.0039
Sexual dysfunction (n=31) * 20/31 (64%) 12/31 (39%) 0.0078

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119

Anatomical outcomes and patient satisfaction in women undergoing open or laparoscopic sacral colpopexy

Rondini, C 1 ; Urzua, MJ 2 ; Alvarez, J 1 ; Andreoli, F 3 ; Monroy, M 4 ; Storme, O 4

1: Hospital Padre Hurtado and Clinica Santa Maria; 2: Hospital Padre Hurtado and Clinica Davila; 3: Hospital Padre Hurtado and Universidad del Desarrollo Chile; 4: Hospital Padre Hurtado

Introduction: To this date many pelvic floor surgeons consider the abdominal sacral colpopexy to be the gold standard for the surgical treatment of apical prolapse. Recently the laparoscopic approach has shown similar anatomical outcomes to the open laparotomy but with less complications. Since the laparoscopic approach provides a better view of the sacrum and the posterior wall of the vagina, this could be advantageous in anchoring the mesh to the posterior compartment.

Objective: The aim of this study is to compare anatomical outcomes between open and laparoscopic sacral-colpopexy with special interest in the posterior compartment and patient satisfaction.

Methods: We performed a retrospective cohort study of all female patients who underwent a sacral colpopexy between January 2010 and December 2017. Baseline demographic information, clinical history and surgical information were obtained from medical records and the hospital urogynecology database. Patients were evaluated following surgery at 3, 6- 12- months and yearly thereafter. Success was defines differently for each compartment. For the anterior and posterior compartment descending no further than the vaginal introitus POP Q: up to -1 cm was considered successful. However, for the apical compartment, success was POP Q point C not descending further than 1/3 of the total vaginal length. Success rates were compared using Kaplan-Meir survival curves, Long-rank p < 0.05 was considered significant. Overall both surgical techniques had similar key features except for the posterior compartment. In the open abdominal approach the posterior mesh was anchored to the lowest portion of the posterior vagina palpable or reachable by the surgical tram. However, on the laparascopic approach the posterior mesh was anchored to the Levator Ani muscle on both sides of the rectum. None of these patients underwent a transvaginal prolapse repair at the time of sacral colpopexy.

Results: Two-hundred and ten women underwent a laparoscopic approach (LSC) and 119 open sacral colpopexy (ASC). Baseline demographic information: age, BMI, parity and other surgical variables such as prolapse severity (stage III-IV prolapse) and concomitant sub-total hysterectomy at the time of surgery were all similar on both groups. (Table No 1). The mean follow-up for both groups was comparable (LSC: 15.9 months vs., ASC: 17.04 months, p: 0.513). Surgical time was higher in the laparoscopic group (LSC: 186.2 minutes vs., 96.8 minutes p: 0.001). When analyzing the different compartments, the apical compartment failed in four cases LSC vs., 9 ASC (p: 0.011); the anterior compartment (LSC 11 vs., ASC 21 p. 0.001) and posterior compartment (LSC 2 vs., ASC 16, p 0.001). Hospital stay (LSC 2.8 days vs., 3.06 p. 0.016). Patients´ overall satisfaction express by how likely was the patient willing to recommend the surgery to a peer was similar in both groups (LSC 94.9% vs., 95.9% p. 0.726) and PGI-I expressed as “similar” or “worst” (LSC: 2.5% vs., 5.9% ASC p. 0.131).

Conclusion: The laparoscopic approach offers better anatomic results, however this comes at double the surgical time, similar complication rate and no clear benefit of patients overall satisfaction.

Table 1. Demographic and Baseline information.

  ASC LSC P Value
Age (years) 57.2 ± 9 56.2 ±10 0.371
Parity 3.5 ± 1.6 3.1 ± 1.8 0.044
BMI 27.9 ± 7.1 29.4 ± 19 0.419
Previous Prolapse surgery (%) 26.1% 18.6% 0.111
Concomitant subtotal hysterectomy (%) 42.0% 43.8% 0.809
POP Stage III-IV % 65.3% 59.5% 0.306

Table 2. Surgical comparison between ASC vs., LSC

  ASC LSC P Value
Surgical time (min) 96.81 min ± 28.5 186.28 ± 55. 0.001
Hospital stay (days) 3.1 ±0.7 2.8 ± 1 0.016
Intraoperative complications (%) 10.1 7.6 0.441
Postoperative complications (%) 19.3 12.9 0.116

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120

Changes of symptoms and quality of life in women with symptomatic pelvic organ prolapse fitted with ring with support pessary: A long – term study

Zhu, L 1 ; Mao, M 1 ; Ai, F 1

1: Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, P.R. China

IntroductionThe ring pessary, as one of the support type, which is easy to insert and remove, and can be successfully fitted at different stages of prolapse, was proposed as the first choice of POP conservative treatment. The use of pessary could not only reduce bother symptoms, but also improve quality of life of patients with symptomatic pelvic organ prolapsed. However, the researches of long-term (longer than 12months) pessary use were limited.

Objective: This is the first study focusing on the effect of long-term the ring with support pessary use on bother symptoms and quality-of-life of patients with symptomatic POP.

Methods: In this prospective observational study, a total of 142 patients with symptomatic POP were successfully fitted with the ring with support pessary between November 2015 and November 2016. All of them were followed up until December 2017. Prolapse and urinary symptoms were assessed, and PFDI-20 and PFIQ-7 were administered at baseline and each follow-up visit. McNemar’s test and paired t tests were used for data analysis.

Results: The median(range) duration of pessary use was 17(13-24)months. 98 (74.8%) continued to use the pessary at the study endpoint. Almost all of prolapse symptoms and more than half of the concurrent urinary symptoms were improved with long-term pessary use. However, de novo SUI occurred in 27.1% patients who had no prior history of SUI. Each scale of PFIQ-7 and PFDI-20 was significantly improved at the study endpoint, with the change in urinary and prolapse scales of both questionnaires demonstrating clinically significant (ES>0.5).

Conclusion: The ring with support pessary is a safe and effective conservative treatment for POP, which can not only relieve the bothersome prolapse and urinary symptoms, but also can improve HRQOL of patients with symptomatic POP(especially in the prolapse and urinary aspects) after long-term use.

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121

Continence outcomes in pelvic organ prolapse surgery

Christmann-Schmid, C1; Baessler, K2; Haya, N3; Maher, C4

1: Cantonal Hospital Lucerne; 2: Franziskus Krankenhaus, Berlin; 3: Lady Davis Carmel Medical Center, and the Ruth and Bruce Rappaport School of Medicine, Technion-Israel Institute of Technology, Haifa; 4: Royal Brisbane and Women's Hospital, Brisabane

Introduction: Pelvic organ prolapse (POP) is a common disease in women and is frequently associated with stress urinary incontinence (SUI).

Objective: To determine the effects of surgery for POP with or without concurrent or delayed continence procedures on the prevention or treatment of SUI.

Methods: We searched the Cochrane Incontinence Group Specialised Register. Randomised controlled trials (RCTs) that included operations for symptomatic POP with or without continence procedures were eligible for inclusion. Primary outcome was subjective postoperative SUI.

Results:

Surgery to treat women with POP and concomitant SUI

Postoperative SUI was not significantly different between groups receiving sacral colpopexy (SCP) with or without Burch colposuspension in one trial (RR 0.78, 95%CI 0.41, 1.50). One study demonstrated that a retropubic MUS is superior to a Burch colposuspension at the time of SCP (RR 0.51 95%CI [0.26, 0.98]).In two RCTs fewer women reported postoperative SUI following concomitant MUS compared with vaginal repair alone (RR 0.30, 95% CI 0.19 to 0.48; n=319; I2=28%). One trial compared concomitant versus delayed insertion of a retropubic midurethral sling (MUS) for SUI during vaginal POP surgery. In the group that received the retropubic MUS three months later the success rates were similar after one year: 83/87 (95%) in the concomitant MUS group versus 47/53 (89%) in the delayed MUS group (RR 2.46, 95%CI 0.73, 8.33).

Surgery to treat women with POP and occult SUI:

Five studies demonstrated without heterogeneity that a concurrent MUS significantly increases postoperative continence rates compared to vaginal repairs alone (RR 0.38, 95%CI 0.26 to 0.55; n=369; I2=44%).

Surgery to prevent SUI in continent women with POP:

Seven studies randomized women to undergo anterior colporrhaphy or anterior transobturator mesh. The metaanalysis demonstrates that SUI develops more frequently after anterior vaginal mesh compared to anterior repair (RR 1.58 95%CI 1.05, 2.37; n=905; I2=0%). This result was maintained after 2-3 years in two trials (RR 1.58, 95%DI 1.05, 2.37). Two studies that assessed the effect of a Burch colposuspension in addition to a SCP produced conflicting results. There was insufficient evidence from one study to determine whether there is a benefit of performing a concomitant prophylactic MUS during vaginal POP surgery in continent women with POP (RR 0.69, 95%CI 0.47 to 1.00; n=220).

Conclusion: In women with POP and SUI (symptomatic or occult), a concurrent MUS reduces postoperative SUI and should be offered when counselling women. One study demonstrated that it might be feasible to postpone the MUS after initial vaginal POP surgery. A Burch colposuspension during abdominal POP surgery reduces de novo SUI rates, but this is based on one underpowered RCT and another RCT produced conflicting results. Furthermore, one trial showed that a concomitant MUS might be superior to a Burch colposuspension if a sacrocolpopexy was performed for POP and concurrent SUI. An anterior colporrhaphy appeared better than transobturator mesh surgery in order to prevent postoperative SUI, however, prolapse recurrence is more common.

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122

Long-term pelvic floor symptoms, recurrence, satisfaction and regret following colpocleisis

Winkelman, W1; Noor, N1; Haviland, M2; Elkadry, E1

1: Mount Auburn Hospital; 2: Beth Israel Deaconess Medical Center

Introduction: Data on long-term outcomes following colpocleisis for treatment of pelvic organ prolapse (POP) are sparse, limiting physicians’ ability to counsel patients. Studies have reported rates of regret of 4.3-9.2% and satisfaction of 90.0-95.0%, however follow-up is typically less than five years.

Objective: Assess long-term outcomes following colpocleisis, including pelvic floor symptoms, POP recurrence, and patient satisfaction and regret with the procedure.

Methods: This is an ambidirectional cohort study of patients who underwent colpocleisis at a single institution from 2002 to 2012. Medical records were reviewed, and patients were contacted by telephone in order to complete questionnaires. After obtaining verbal consent, patients answered Likert scale questions about their overall satisfaction. Patients also completed a modified Decision Regret Scale (DRS), a five-item questionnaire designed to measure regret after healthcare decisions. They also completed the Pelvic Floor Distress Inventory – Short Form 20 (PFDI-20), which comprises the Urinary Distress Inventory (UDI), Pelvic Organ Prolapse Distress Inventory (POPDI), and Colorectal-Anal Distress Inventory (CRADI). Data are presented as n (%) or median (interquartile range).

Results: During the study period, 73 eligible patients underwent colpocleisis. The median age at the time of the surgery was 78.1 (75.2-84.9) years. Most patients (70.0%) had stage III or stage IV POP. Fifty-two (71.2%) had preoperative stress urinary incontinence (SUI) and 38 (52.1%) had evidence of detrusor over activity. Of the 73 patients, 24 (32.9%) were deceased and 16 (21.9%) had no valid contact information. We were able to contact the remaining 33 patients, and 32 agreed to participate in the telephone survey. The demographic characteristics of those we were able to contact were similar to those of the overall cohort. The median time between surgery and telephone survey was 6 years (IQR 6.0-8.5). Twenty-five (78.1%) were satisfied with the procedure. Three (9.4%) thought the colpocleisis did them harm, and all three cited new onset urgency urinary incontinence. Half (46.9%) reported no regret, 11 (34.4%) reported mild regret, and 4 (12.5%) reported strong regret on the DRS. No patients reported regret over loss of sexual activity.Twenty-three (71.9%) patients reported symptoms on the PFDI-20. Twenty (62.5%) reported urinary symptoms on the UDI-6, with the majority reporting urinary frequency (62.5%) and urgency urinary incontinence (56%). Bowel symptoms were less common; 14 patients (44%) reported symptoms on the CRAD-8. Only six patients (19%) reported symptoms on the POPDI-6 and those with symptoms had a mean score of 18.75 with a maximum score of 33 out of 100. No patients reported symptoms on the POPDI-6 that bothered them “moderately” or “quite a bit.”

Conclusions: Our data suggests that colpocleisis remains a good option for surgical treatment of prolapse, however surgeons must be mindful of bladder and defecatory symptoms that may develop postoperatively. While patients generally report high levels of satisfaction, bowel and bladder symptoms may explain higher rates of regret seen over the long-term These data support the continued use of colpocleisis but highlight the need to set appropriate expectations during counseling.

Disclosure:

Work supported by industry: no.

123

Does cross-sectional area of the pubovisceral muscle get smaller with aging and prolapse?

Swenson, C 1 ; Chen, L 1 ; Masteling, M 1 ; DeLancey, JOL 1

1: University of Michigan

Introduction: Levator injury is a risk factor for prolapse; however, it is not a ubiquitous finding. The pubovisceral muscle (PVM) is the levator most closely associated with the genital hiatus. As a skeletal muscle, the PVM may undergo age-related atrophy which could impair pelvic support even in the absence of an injury. We recently developed a novel MRI-based technique to measure cross-sectional area (CSA) of the PVM’s true line of action. Changes in PVM CSA that occur with aging and its relationship to prolapse are unknown.

Objective: To test the hypothesis that a) increasing age and b) prolapse are both associated with a smaller PVM CSA in women without major levator injury when compared to young nulliparous controls with normal pelvic support. To determine the correlation between PVM CSA and genital hiatus size.

Methods: We conducted a pilot study using 3D Stress MRIs from pelvic floor studies at our institution from 2001- 2018. Women without major levator ani defects were included in three groups: 1) young nulliparous women without prolapse, 2) older women without prolapse, and 3) age-matched older women with prolapse. PVM CSA was measured by rotating the coronal plane to an axis normal to the mid-sagittal plane and normal to the PVM fiber direction. Maximal CSA along the muscle length was used for analysis. Hiatus measures were made using mid-sagittal images at rest and maximal strain. Genital hiatus was measured from the inferior pubic point to the mid-perineal body and levator hiatus was measured as the shortest distance from the interior pubic point to the levator plate. Demographics, PVM CSA, and hiatus measures were compared. Pearson correlation was used to determine the correlation between PVM CSA and genital hiatus measures.

Results: MRIs of 40 women were included: 10 young controls, 10 older controls and 20 older women with prolapse (10 cystocele, 10 rectocele). Groups differed by age and parity but BMI was similar (Table 1). Average PVM CSA in the prolapse group was 32% larger than the older controls (p=.006); older and young controls had similar PVM CSA (p=.917). There was no difference in PVM CSA between those with cystocele and rectocele (1.44 ± 0.43 mm vs 1.35 ± 0.28 mm, p=.56). All hiatus measures were largest among the prolapse group. Resting genital hiatus was 11 mm larger among women with prolapse compared to older controls (p=.004) and 5 mm larger among older versus young controls (p=.206) A similar trend was seen with the straining genital hiatus measures. Straining levator hiatus size was 36% larger in the prolapse group versus older controls (p = .017). The correlation between PVM CSA and genital hiatus at rest was 0.201 (p=.215) and with strain it was 0.387 (p=.014).

Conclusions: Pubovisceral muscle CSA is significantly larger in women with prolapse compared to younger and age-matched controls. There was a low correlation between PVM CSA and genital hiatus size. Our findings suggest that in women with intact levators, thinning of the PVM may not be the primary cause of prolapse.

Funding Acknowledgements: K12 HD065257, R01 HD 38665, P50 HD 44406

Table 1.

  1
Young Controls
N=10
2
Older Controls
N=10
3
Older Prolapse
N=20
p-values
1 v 2 1 v 3 2 v 3 ANOVA
Age, years 24.2 ± 3.46 56.3 ± 4.88 59.70 ± 10.87 <.0001 <.0001 .565 <.0001
Caucasian, % 7 (70) 10 (100) 14 (70) .060 >.99 .053 .144
Body Mass Index, kg/m2 26.03 ± 4.45 28.07 ± 4.54 27.10 ± 5.03 .677 .910 .931 .637
Parity 0 3 (2, 4) 2 (2, 3) <.0001 <.0001 .218 <.0001
Right PVM CSA, cm2 1.07 ± 0.33 0.97 ± 0.20 1.32 ± 0.40 .768 .232 .010 .026
Left PVM CSA, cm2 0.99 ± 0.22 0.97 ± 0.21 1.22 ± 0.25 .995 .053 .027 .010
Average PVM CSA, cm2 1.11 ± 0.32 1.05 ± 0.21 1.39 ± 0.35 .917 .115 .006 .011
Genital Hiatus Rest, mm 27.16 ± 5.15 32.16 ± 6.63 43.18 ± 9.69 .206 <.0001 .004 <.0001
Genital Hiatus Strain, mm 32.20 ± 5.57 36.88 ± 7.71 58.00 ± 14.22 .350 <.0001 <.0001 <.0001
Levator Hiatus Rest, mm 51.41 ± 7.06 54.59 ± 7.69 57.79 ± 7.89 .711 .102 .644 .105
Levator Hiatus Strain, mm 56.38 ± 12.82 51.40 ± 14.01 69.82 ± 18.44 .792 .082 .017 .011

Data presented as mean ± SD or N (%) or median (IQR). For continuous variables, p-values were determined using Dunnett’s test or Mann-Whitney U (parity). ANOVA or Kruskall Wallis test (parity) was used for three-group comparisons. P-values for “Caucasian” variable determined using Chi-Square test. PVM: pubovisceral muscle, CSA: cross-sectional area

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Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Hologic, Proctor and Gamble).

124

Effects of exosomes secreted by human urine-derived stem cells on stress urinary incontinence in rat model

Hou, M1; Wu, R1; Wu, Q1; Cao, Y1; Jia, X1; Huang, C1; Qiu, Y1; Niu, X1; Wang, Y1

1: Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Introduction: Stress urinary incontinence (SUI) is a severe social and medical condition in 10–20% females worldwide. Presently, a convenient and non-invasive treatment with low side effects is lacking. Surgery is the main treatment for SUI accompanied by trauma. Considering allogeneic and xenogeneic immunological rejection, stem cell transplantation therapy is also risky. It is imperative to find a novel biotherapy with low trauma for SUI.

Objective: To evaluate the effects and the mechanism of exosomes secreted by human urine-derived stem cells (USCs-Exo) on repairing stress urinary incontinence in rats.

Methods: USCs were detected by fluorescence-activated cell sorting (FACS) analysis, while proliferation was assayed by Cell Counting Kit-8 (CCK-8). Exosomes from conditioned medium of USCs were isolated using ultrafiltration-combined purification methods and verified by morphology, size, and specific biomarkers using transmission electron microscopy and Western blotting. USCs and USCs-Exo were injected into SUI rats for repair, and the efficacy was assessed by testing the abdomen leak point pressure (ALPP), histological examination, and immunohistochemistry analysis. Rat skeletal muscle satellite cells (MSCs) were treated with USCs-Exo, and the effects on the proliferation of MSCs were evaluated using CCK-8.

Results: FACS analysis showed that USCs were strongly positive for CD29, CD73, and CD90 and negative for CD34, CD45, and HLA-DR. The USCs-Exo were spheroidal microvesicles with 30–150 nm diameters and expressed exosomal markers, CD9 and CD63 proteins. The periurethral injection of USCs-Exo and USCs showed improvements in ALPP and enhanced urethral muscle layer formation in SUI rats for a short-time (4 weeks post-injection). Immunohistochemistry showed that both USCs-Exo and USCs increased the expression of α-smooth muscle actin and myosin heavy chain at weeks 4 and 8. In vitro, USCs promoted proliferation of rat MSCs, which might be related to muscle regeneration.

Conclusion: Exosomes derived from human USCs improved SUI, which might be correlated to the enhancement of muscle regeneration and promoted proliferation of MSCs.

Reference

1. Epidemiology of urinary and faecal incontinence and pelvic organ prolapse [J]. 2008.

2. Surgical management of urinary stress incontinence in women: a historical and clinical overview [J]. European Journal of Obstetrics Gynecology & Reproductive Biology. 2009;145(2):219.

3. Periurethral collagen injection for the treatment of female stress urinary incontinence: 4-year follow-up results [J]. Urology. 1999;54(5):815-818.

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125

Effect of a fasciatechnique on the diastasis recti abdominis in the early puerperal

Egger, C 1 ; Anderl, J 1 ; Rumpold, T 2 ; Gödl-Purrer, B 3 ; Siller, M 4

1: Landeskrankenhaus Bludenz, Physiopelvis Dornbirn, Austria; 2: Wiener Schule für Osteopathie, Wien, Austria; 3: FH Joanneum, Granz, Austria; 4: FH Salzburg, Salzburg, Austria

Introduction: Diastasis recti abdominis (DRA) is characterized by a separation of the muscle bellis of the rectus abdominis muscles (RA) alongside the Linea Alba and this is a normal process during pregnancy. The proposed clinical pilot study, examined the effectiveness of an osteopathic fascial technique, applied in the early postpartum phase, on reduction of increased DRA to a normal distance. Mota et al. (2015) describe in their study that more than half of the propositi showed an abnormal distance in their rectusbellies 8 weeks postpartum, some of them could recover after six months; others however still presented a separation after one year. Currently, no studies could be found that display the effectiveness of a fascial technique on the DRA during the early puerperal phase.

Objectives: Fascial osteopathic techniques try to influence stiffness and elasticity and mechanosensitivity of connective tissue by stimulating the mechanoreceptors with manual mobilisation techniques. First objective of the study was to test the hypothesis that application of fascial techniques in females in the early puerperal phase would reach accelerated occlusion of the musclebellies of RA. Second objective was to test correlation of urinary incontinence and DRA in the early puerperal phase. .

Method: This is a randomized clinical trial and a pilot study. Ethical approval was given by the province of Vorarlberg. A convenient sample of 40 postpartal women was randomly assigned to an intervention group (20) and a control group (20). All women underwent a basic ultrasonographic test on two different measurement points alongside the Linea Alba as described in literature.Testing was repeated three times during the study. At each time manual fascial techniques were performed. Urinary incontinence was measured with the ICIQ-UI-SF questionnaire to look for correlation between DRA and postpartal incontinence. The degree of task specific self-efficacy in regard to the fasciae technique was determined using a validated self-efficacy questionnaire.

Results: Data of 39 female were analysed. The within group analysis showed significant change of DRA distance over time in both groups (F (2) = 6,418; p ≤ 0.001). There was no significant difference for DRA distance in the between groups analysis between the intervention and the control group at any point of time. There was no statistically significant correlation between recovery of DRA and grade of urinary incontinence (p=0,368 respectively p=0,825).

Conclusion: In summary, the findings imply that not the intervention but rather the factor time plays an important role in the regression of the DRA.

Mota, P., Pascoal, A. G., Carita, A. I., Bo, K. (2015). Prevalence and risk factors of diastasis recti abdominis from late pregnancy to 6 month postpartum, and relationship with lumbo-pelvic pain. Manual Therapy; 20: 200 – 205.

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126

Quantitative Microbiology is unhelpful in distinguishing female chronic LUTS patients from controls even with enhanced cultures

Swamy, S 1 ; Sathiananthamoorthy, S 1 ; Tuz, M 1 ; Gill, K 2 ; Malone-Lee, EPJ 2

1: University College London; 2: UCL

Background: There is growing interest in chronic cystitis in the aetiology of chronic LUTS. By far pyuria count on microscopic examination of fresh clean catch midstream urine is the best marker but even this will detect only 61-70% of infections. Studies by Stamm, and Latham confirms that using this gold standard MSU threshold will miss 50% of acute infections. So the tests used routinely to exclude urinary tract infection (UTI) have been discredited across the spectrum of disease, catalysing a critical analysis of our assumptions (1, 2).

Hypothesis: Patient with Chronic LUTS show a qualitatively different urinary microbiome when compared to controls. Patients with Chronic LUTS show increased urinary inflammatory signals compared to controls.

Ethics: This study had ethical committee approval from NRES Committee South East Coast – Surrey, Ref-11/LO/0109

Methods: This prospective blinded observational study was conducted at a tertiary unit from July 2013 to June 2014. Adult, non-pregnant women attending their first appointment at the community LUTS centre were recruited. Asymptomatic hospital and clinic staff and their relatives and acted as controls. Variations in symptoms were measured using validated questionnaires. All urine samples are anonymised to ensure blinding. The microbiological evidence of infection is being evaluated through: microscopy of fresh urine for pyuria and epithelial cell shedding and urinary cell sediment culture and identification of bacteria. Urine cytology was assessed using epiflorescent staining of urothelial cells and the proportion of clue cells recorded.

Results: 29 were controls and 128 were female LUTS patients were included in the study. There was no significant difference in the age and BMI between controls and patients. They had suffered symptoms for a mean of 6.5 years, and presented with a marked overlap of LUTS symptoms – storage, pain, voiding and stress urinary incontinence. 67% of our patients had Urgency, disasthesia a presenting feature in 37%, Voiding symptoms in 34% and stress symptoms in 14%. There was a statistically significant difference in the symptom scores as one would expect. Pyuria and epithelial cell counts on fresh urine microscopy and mean proportion of clue cells also showed a statistically significant difference in quantitative microbiology using sediment cultures proved statistically significant but practically irrelevant (Fig 1).

Conclusion: The female urinary tract is a previously overlooked microbial niche. These data indicate that quantitative microbiology irrespective of the threshold used is unable to distinguish a patient from a control and the symptoms are the key to their diagnosis. Symptoms and pyuria are key to the diagnosis of infection.

References:

  1. 1.

    Stamm 1982

  2. 2.

    Latham 1985

Fig 1. Microbial diversity in Female LUTS vs Controls. Each genus isolated: Proportion from LUTS patients vs proportion from controls

figurebe

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128

Microablative fractional CO2-laser for the management of genitourinary syndrome of menopause. A placebo controlled histopathogical pilot study

Pitsouni, E 1 ; Grigoriadis, T 1 ; Zacharakis, D 1 ; Theocharis, S 1 ; Danas, E 1 ; Douskos, A 1 ; Salvatore, S 2 ; Athanasiou, S 1

1: National and Kapodistrian University of Athens, Greece; 2: Ospedale San Raffaele, Milano, Italy

Introduction: Microablative Fractional CO2-laser administered intravaginally, may induce changes of the vaginal atrophic mucosa restoring the local pathophysiology. Specifically, an observational histopathological study including 5 postmenopausal women with severe symptoms of vaginal atrophy (VVA), have indicated that CO2-laser may increase the thickness of the vaginal epithelium, storage of glycogen and the content of blood vessels. However, the possible placebo effect of the CO2-laser therapy in postmenopausal women have not been evaluated yet.

Objective: The current placebo-controlled histopathological pilot study aimed to identify changes of the vaginal mucosa of postmenopausal women receiving 3 CO2-laser therapies due to the severe intensity of GSM symptoms.

Methods: Punch biopsies were obtained from the lateral vaginal wall at baseline and 1 month-following 3 CO2-laser therapies (active or placebo). Variables to be evaluated in both the active and placebo group, were the thickness of the vaginal epithelium (ET) and indications of neoaggeiogenesis such as increase of the number of blood vessels and decrease of vessel’s diameter, length, size, width and density. In addition, the proportion of estrogenic receptors (ER) in the epithelium and stroma of the vaginal samples from the active group were to be estimated in case that statistically significant differences between the compared groups would be detected. All variables were evaluated before the initiation of therapies (baseline) and 1-month following the 3rd therapy (1-month follow-up). Statistical analyses were performed within and between groups.

Results: Thirty-six women were included in the current study (18 and 18 in the active and placebo group, respectively). Baseline characteristics were different between the compared groups: age 58.1±4.6 (active group) and 56.4±3.1 (placebo group); years since last menstrual period 7.1±4.7 (active group) and 7.8±5.6 (placebo group); Body mass index 24.1±3.3 (active group) and 24.7±3.3 (placebo group). The mean differences of all outcomes from baseline to 1-month follow-up between the compared groups were statistically significant different (Table 1). The active group appeared to decrease the vessel’s diameter, length and width, and to increase the density, number of vessels and ET. In addition, ER seemed not to be changing. In the placebo group at 1-month follow-up, all but 1 variable remained the same as at baseline. Density seemed decreasing from baseline to 1-month follow-up.

Conclusions: Placebo effect or changes on the estrogenic receptors of the vagina may not be the mode of action of CO2-laser therapy. Parameters indicating a restoration process to a healthier status of the atrophic vaginal mucosa, such as neoaggeiogenesis and thickening of the vaginal epithelium was indicated in the active group. The latter parameters, as would be expected, did not change in the placebo group with the exception of vessel’s density. Decrease of vessel’s density implied that the natural progression of vaginal atrophy was present in the placebo group. However, the current study includes a small number of participants and safe conclusions cannot be derived. Thus, randomized controlled trials with a larger sample size evaluating additional variables of the vaginal mucosa are needed.

Table 1. Comparison of outcomes within and between groups.
  Mean difference *
Active (n=18)
p-value (comparison of changes within group) # Mean difference *
Placebo (n=18)
p-value (comparison of changes within group) # p-value (comparison of changes between groups)
Vessels      
Diameter -16.7±9.4 <0.001 2.9±6.5 0.1 <0.001
Length -31.5±22.6 <0.001 -3.3±15.1 0.6 <0.001
Width -16.2±10.8 <0.001 -0.7±7.7 0.9 <0.001
Density 11.1±15.8 0.004 -12.1±24.4 0.01 <0.001
Number 9.3±13.1 0.02 -0.2±10.3 0.8 0.02
Epithelial thickness 58.2±41.6 <0.001 -20.7±44.3 0.07 <0.001
Estrogenic Receptor (epithelium) 2.8±29.6 0.3 NA NA NA
Estrogenic Receptor (stroma) 1.2±19.5 0.05 NA NA NA

** Data are presented as mean. The sign of minus represents the decrease of values after 3 laser-therapies. Absence of sign represents the increase of values after 3 laser-therapies.

# Statistical significance was set at 5% (p<0.05). Statistical significant p-values are presented in bold.

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129

Hysterectomy adversely affects bladder funcion in the future

Hayashi, T 1 ; Nomura, M 1 ; Moriyama, S 1 ; Tokiwa, S 1 ; Sawada, Y 1 ; Huang, T 1 ; Ghia Gonocruz, S 2 ; Meutia, A 2 ; Krisna, R 2

1: Urologist; 2: Gynecologist

Introduction: Hysterectomy has been performed for the treatment of several uterine diseases, for exlample myoma or pelvic organ prolapse (POP). However it has been suggested that after a hysterectomy, some influences to bladder function may occur.

Objective: In this study, we are compared to the differences in micturition status between patients who had been hysterectomized or not.

Method: The subject was preoperation patients who consulted our hospital to underwent the treatment for their POP from April 2012 to April 2017. In the preoperation examination, the physiological saline was infused into the bladder by transurethrally, the maximum bladder capacity was measured and then the uroflowmetry was performed. Finally, the amount of residual urine volume was mesured using BLADDERSCAN®. The state of urinary incontinence was also evaluated using ICIQ-SF questionnaire and its distribution pattern was evaluated.

Results: The hysterectomized group (HG): 108 people (74.5 ± 6.1 y.o) and non hysterectomized group (NHG): 830 people (72.3 ± 7.4 y.o) were entried in this study. In the classification of urinary incontinence by ICIQ-SF, there is no difference of incontinence pattern between two groups (HG: 32.5% without urinary incontinence, 22.3% only with stress urinary incontinence (SUI), 25.1% with urge urinary incontinence (UUI) and 20.1% with mixed urinary incontinence (MUI). NHG: 31.2% without incontinence, 24.8% with only SUI, 22.7% with only UUI and 21.3% with MUI). In the micturition test, the bladder capacity of maximum desire to void were 298.9 ml in HG and 325.1 ml in NHG (p = 0.059), the maximum flow rate (Qmax) was 18.2 ml / s in HG and 20.9 ml / s in NHG (p <0.01), the average flow rate (Qave) was 9.8 ml / s in HG and 12.0 ml / s in NHG (p <0.01), and the post voiding residual urine volume (PVR) were 66.4 ml in HG and 47.8 ml in NHG (p < 0.05). The reduction of functional bladder capacity and urinary flow stream and increase in PVR were observed in HG compared to NHG.

Conclusion: Although hysterectomy does not change the incidence frequency of urinary incontinence, it has a negative effect on decreased functional bladder capacity, increased amount of residual urine. Hysterectomy may be a risk of future voiding disfunction so that uterine preservation should be considered if possible.

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130

Clinical outcomes of detrusor underactivity in female with advanced pelvic organ prolapse following vaginal pelvic reconstructive surgery

Lo, T 1 ; Chua, S 1 ; Kao, C 1 ; Huang, S 1 ; Lin, Y 2 ; Al-kharabsheh, AM 3

1: ChangGung Memorial Hospital, Keelung, Taiwan; 2: ChangGung Memorial Hospital, Linko, Taiwan; 3: Mu'tah University, Al-Karak, Jordan

Introduction: Detrusor underactivity (DU) is defined as a contraction of reduced strength and/or duration resulting in prolonged bladder emptying and/or failure to achieve complete bladder emptying within a normal time span by ICS. However, this definition is hampered by subjective interpretation of what constitutes reduced strength. What has been agreed regarding the diagnosis of DU is that an urodynamics is the only definitive method of measuring detrusor contractile function. No study has evaluated the clinical features of DU on Pelvic organ prolapse (POP) patients.

Objective: This study aims to determine the impact of vaginal pelvic reconstructive surgery on DU patients having advanced POP.

Materials and Methods: A retrospective study (January 2006 to January 2016) on 1,531 women with pelvic reconstructive surgery (PRS) for advanced POP (POPQ≧stage 3). Among them, 51 had DU. Preoperative evaluation included medical history, physical exam, 72-hour voiding diary, multichannel urodynamics and validated questionnaires (UDI-6, IIQ-7, and PISQ-12). Surgical procedures included vaginal hysterectomy, anterior colporrhaphy with or without transvaginal mesh, sacrospinous ligament fixation, posterior colporraphy and mid-urethral sling (MUS) when indicated. Data regarding preoperative evaluation, surgical procedure, and post-operative management were collated. Patients were considered to have DU when detrusor pressure at maximum flow (PdetQmax) was <10cmH20 and peak flow rate (Qmax) of <12 ml/s. Post-operative values more than the cut off were considered objectively cured. Subjective cure defined as having a negative response to UDI-6 Question 5.

Results: A total of 49 patients were evaluated. Mean age was 67.5+5.3 years old. 38 patients (74.5%) presented with stage III prolapse and 13 (25.5%) with stage IV preoperatively. Six patients (11.8%) had prior pelvic surgeries and 38 had different medical diseases with hypertension (49%) and diabetes mellitus (21.6%). 45 patients (88%) tolerated the condition for more than 3 years prior to surgical intervention. The mean operating time was 68.2+16.8 minutes with intraoperative blood loss of 80.0+66.9 ml and hospital stay of 4.5+1.1 days. Post-operative complications include mesh exposure, post-operative voiding dysfunction needing self-intermittent catheterization, stroke, and secondary surgery for urine incontinence. Objective cure of DU was 46.9% (23/49; Qmax>12mL/s and PdetQmax>10cm H20)and subjective cure was 75.5% (37/49). Post-operative DU (p<0.001) significantly improved together with patients having normal urodynamic diagnosis (p<0.001). Voiding function after 1 year showed 87.8% (43/49) with post-void residual urine (PVR) of <200ml, 63.3% (31/49) with Qmax >12m/s, and 57.1% (28/49) with PdetQmax>10cmH20. And data comparison showed significant increase in Qmax (p<0.001) and PdetQmax (p<0.001) while PVR (p<0.001) and cystometric capacity (p<0.001) significantly decreased.

Conclusion: Reversal of short-term or long-term obstruction through vaginal pelvic reconstructive surgery can enable bladders to regain detrusor muscle function. However, early intervention for POP causing BOO is essential since the duration of obstruction influences the functional capacity of the bladder, which leads to a state of decompensation. Despite having an objective cure of DU at 47%, detrusor function resumed in 57% providing DU patients a chance of recovery, provided that mechanical obstruction is the cause and resolved with pelvic reconstructive surgery.

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131

The nature recovery process of postpartum pelvic floor muscle function

Sun, X1; Wang, R2; Wang, J1

1: Peking University People's Hospital; 2: Peking University People's Hospital, Beijing, China

Introduction: It was estimated that around 200 million women suffer from pelvic floor disorders (PFDs) in China. Most patients who come to see doctor are in advanced stages and need surgery, which bring suffering and finical burden to both family and Nation. Pregnancy and delivery especially vaginal difficulty birth had been proved to be the independent risk factors of PFDs. Pelvic floor muscle (PFM) is the most important part of pelvic support, thus screening the PFM function (PFMF) in postpartum women and identify the abnormal in early stage is the key point for PFDs prevention. Most practitioners used 6 weeks postpartum as the time point for the diagnosis of abnormal PFMF and provide rehabilitation to those with abnormal findings. But there is still no clear answer about how long dose the PFMF need to recover from the physiological impact of pregnancy and delivery. So it is important to find out the cutoff point of PFMF recovery process and to guide clinical practice so as to avoid the false positive results and over-intervention.

Objective: To study the postpartum recovery process of PFMF by comparing the PFMF in different time after delivery.

Methods: A cross-sectional survey was conducted. Uncomplicated singleton gestation women who gave their first birth in our department during August 2016 to November 2016 were recruited, those who underwent PFM training were excluded. Women were assigned to 6, 10 and 14wks group according to postpartum time. PFMF was evaluated by PHENIX USB2 ( Electronic Concept Lignon Innovation, France) with parameters of vaginal pressure (VR), strength of type I muscle (SI), strength of type II muscle (SII) , fatigue of type I muscle (FI) and type II muscle (FII).

Results: 1. Totally 347 women enrolled with 114, 143 and 90 cases in 6, 10 and 14wks group. The baseline characteristics of each group had no significant difference (P>0.05). 2. The average VR in 6wks group (62.83cmH2O) was significant lower than that in 10wks group (90.70cmH2O) and 14wks group (95.14 cmH2O) (P<0.001), but no difference between 10wks and 14wks groups (P>0.05)(Fig. 1). 3.The average SI in 6wks g (3.74) and 10wks group (3.71)were significantly lower than that in 14 wks group (P<0.001), no big difference between 6wks and 10wks group (P>0.05) . The average SII was 3.71, 4.22 and 4.84 in each group and significant differences was demonstrate among the three groups (Fig. 2). 3.The average degree of FI was -0.86, -0.76 and -0.24, of FII was -0.3,-0.27 and -0.04 in each group, showed that the fatigue of muscle improved much after 14 weeks postpartum (P<0.001) (Fig. 3).

Conclusions: The PFMF recovers gradually after child birth which shows abonormal values at 6 weeks and almost reach the normal range at 14 weeks postpartum. The result remind us that using 6 weeks postpartum as the time point for diagnose abnormal of PFMF may lead more false postive result and over.

figurebf

Fig 1. Vaginal pressure of each group

figurebg

Fig 2. Strength of muscle in each group

figurebh

Fig 3. Fatigue of muscle of each group

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132

A review of mobile voiding diary apps: Content and functionality features

Vaccari, N1; Silveira, L1; Haddad, J1; Baracat, E1; Bertolini, MA2; Ferreira, E1

1: Universidade de São Paulo - USP; 2: Universidade Federal de São Paulo

Introduction: Voiding diary is a non-invasive method to investigate low urinary tract symptoms. Paper voiding diaries may present low filling rates and inconsistency of data1. The use of mobile devices has grown exponentially worldwide and may help to improve health monitoring, clinical data collection, and communication between the patient and the health professional.

Objective: The objective of this study was to systematically review the existent voiding diary applications (apps) for mobile devices and to classify them according to their quality.

Methods: Two physiotherapists independent investigators performed a search in iTunes and Google Play platforms using the keywords: “voiding diary”, “bladder diary”, “urinary diary”, “urinary incontinence”, “pelvic floor”. Inclusion criteria: apps with proposal of voiding diary in English, Portuguese, Spanish or French language, free of charge and able to be installed on the mobile devices. We excluded apps that could not be accessed without password provided by the developer, apps that did not allow registering voiding diary data and apps intended for pediatric population.

Based on previous literature and on a panel consensus developed by the study researchers, apps were analyzed according to functionality features and 10 items with important voiding diary information were identified: type of intake, volume of intake, episodes of voiding, volume of voiding, incontinence episodes, type of incontinence, degree of urgency, amount of urine leak, use/change of pads and nocturia. Additionally, two researchers independently evaluated each app using Mobile App Rating Scale, MARS2 to assess the quality of health mobile apps, which rates the apps domains with scores from 1 (inadequate) to 5 (excellent). The study was reported according to PRISMA guidelines.

Results: 37 apps were found, 28 were excluded. The nine included apps were: Diário Miccional, Mictionary, Day2Day, Diagnoluts En, Plog, Diario Micc, Urolog, Bladder Strategy and Kegel Nation. Apps were quite different from each other. None of them presented all the 10 desired items; the median of items was 6 (3-7). The most frequent feature was “incontinence episodes” which was present in eight apps. The least frequent feature was nocturia, present in only one app. MARS mean score is shown in Table 1.

Table 1. Domains and mean score for the Mobile App Rating Scale.

  Engagement Functionality Aesthetics Information App quality mean score Subjective quality App Specific
UroLog 4.7 4.3 4.5 4.5 4.5 5.0 4.8
Mictionary 4.5 4.3 3.8 4.2 4.2 4.3 3.9
Diario Miccional 3.3 4.5 4.7 3.3 3.9 3.1 2.3
Diagnoluts En 4.0 3.6 3.5 3.9 3.8 3.8 4.5
Day2Day 3.6 4.4 3.5 3.4 3.7 3.1 2.7
Kegel Nation 3.8 3.5 3.5 3.1 3.5 2.4 4.2
Diario Micc 3.2 4.4 2.3 2.5 3.1 2.6 2.7
Bladder Strategy 2.4 2.6 2.5 2.3 2.5 1.3 3.0
Plog 1.4 2.1 1.0 2.4 1.7 1.0 1.7

Conclusion: The evaluated mobile voiding diary applications are very different from each other, and mainly focus on the symptom of urinary incontinence. Health professionals should analyze the apps to choose the most appropriate for patient’s needs.

1J Pediatr Urol. 2016 Apr;12(2):112.e1-6.

2JMIR mHealth and uHealth. 2015;3(1):e27

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133

Laparoscopic repair of female genitourinary fistulae 10 years Single-center experience

Abdelkarim, A1; Abulfotooh Eid, A1; Elmissiry, M1; Mahfouz, W1; Moussa, A1; Elsalmy, S1

1: Department of urology, faculty of medicine, university of Alexandria

Introduction: Over the last two decades, recent advancement in minimally invasive surgery has prompted surgeons to perform fistula repairs with laparoscopic or robotic assisted laparoscopic techniques.

Objective: We present our experience of laparoscopic repair of different types of female genitourinary fistulae that represent a 10 years single- center experience

Methods: A retrospective analysis of our records over the last 10 years was performed where the types of the female genitourinary fistulae, the etiology, the laparoscopic approach performed, operative data, postoperative outcome and follow up of the patients were recorded.

Results: Overall 42 patients with different genitourinary fistulae were reported where 24 had vesicovaginal fistula (VVF), 13 had vesicouterine fistula (VUF) and 5 had ureterovaginal fistulae (UVF). Interpretation of results. All patients developed their fistulae following either obstetric or gynecological surgeries except one patient had post-irradiation VVF. All patients had 3-5 port conventional laparoscopic repair of their fistula except 7 patients with VVF and 6 patients with VUF had laparoendoscopic single-site (LESS) repair. In all patients with VVF and VUF extravesical repair was done where the fistulous tract was excised and both the bladder and the vagina or the uterus were closed in separate layers with interposing tissue in-between. While in patients with UVF extravesical ureteric re-implantation was done. The overall mean operative time was 176 ± 25 minutes. The mean blood loss was 105 ± 25 c.c. There were no intraopertaive or postoperative complications in all patients. None of the patients was converted into open surgery, however in all patients who had LESS repair of their fistula but one with VVF, one 5-mm extraport was added. The overall mean postoperative hospital stay was 3.2 ± 1.2 days, however the mean postoperative hospital stay for patients who had LESS repair was 2 ± 0 days. The mean follow up of the patients was 6.3 ± 3.1 years. All patients had successful repair but one patient with complex VVF (two large fistulae that measured 2 and 2.5 cm) that had LESS repair where the omentum was too short and only peritoneal flap was used as an interposing tissue.

Conclusions: Laparoscopic repair of VVF, VUF and UFV is technically feasible and safe procedure with high success rate and low morbidity. LESS repair of VVF and VUF is a valid alternative with comparable success rate to conventional laparoscopic repair and shorter hospital stay. However laparoscopic repair of female genitourinary fistulae is a technically challenging procedure that requires good laparoscopic skills.

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Work supported by industry: no.

134

Laparoscopic removal of mid-urethral sling Mesh for chronic pain: Feasibility and long-term outcomes

Goodall, L1; Cartwright, R1; Jackson, S1; Price, N1

1: Oxford University Hospitals NHS Trust

Introduction: As media attention has highlighted safety concerns about mesh, more women are requesting mesh excision. Patients may attribute very diverse symptoms to insertion of mesh, including chronic pelvic pain, chronic fatigue, fibromyalgia, and pain distant from the pelvis. For women requesting complete excision of mesh an open or laparoscopic approach is needed to dissect out the retropubic arms. The laparoscopic approach provides a superior view of the retropubic space, and offers advantages of quicker recovery and better cosmesis. Laparoscopic removal of the retropubic portion has rarely been described. The few available case series [1-3] provide limited evidence on safety, symptom resolution and impact on recurrent incontinence.

Objective: We aimed to report technical feasibility and operative outcomes for complete and partial removal of mid-urethral slings, and evaluate patients’ perceptions of surgery, including its effects on pain and urinary incontinence.

Methods: We identified all patients who underwent laparoscopic removal of mid-urethral sling mesh at two local hospitals between 2011 and 2016. We extracted data from medical, and contacted all patients with a postal questionnaire, incorporating objective measures of pain, symptom severity and satisfaction. We used multivariate logistic regression to test for predictors of pain resolution and recurrence of stress incontinence.

Results: Over the period 2010 to 2016, 56 patients had a laparoscopic removal of a retropubic sling for chronic pain. The mean age was 48.5 years (range 30 - 71 years). The mean BMI was 28.4 (range 18 – 40). Nine women had a prior attempt to remove or trim the sub-urethral mesh using a vaginal approach. The mean time from insertion to laparoscopic excision was 44 months (range 3 – 192 months). The cases took a median of 85 minutes (range 49-150 minutes). No case was converted to laparotomy. There was one return to theatre in the first 24 hours to evacuate a retropubic haematoma, but no bowel, bladder or ureteric injury occurred. The median inpatient stay was 2 days (range 1-7). Of the 46% (n= 26) of patients who returned the questionnaire, 88% said they would recommend the procedure. There was a median 6 point decrease in pain scores (10 point VAS scale, p<0.0001). 45% experienced worse subjective stress urinary incontinence. In logistic regression looking for improvement or resolution of pain at follow up, there was no impact of age (OR 0.99/year 95%CI 0.91-1.09), length of time sling in situ (OR 1.02/month 95%CI 0.99-1.04), or prior attempt at surgical removal (OR 2.70 95%CI 0.29-25.8). In a separate logistic regression model, excision of the suburethral portion of the mesh was strongly associated with de novo or worsening of stress incontinence (OR 10.72 95%CI 1.10-104.00).

Conclusions: Laparoscopic removal of a mid-urethral sling is feasible, with limited early complications. We identified no factors associated with resolution of pain, although most patients did report improvement or resolution of pain. De novo or worsening stress incontinence was common, and was strongly associated with removal of the sub-urethral portion of mesh. Careful preoperative counselling is required so that patients have realistic expectations for outcomes from this procedure.

References

1. J. Urol.184, 610–615 (2010).

2. JSLS10, 220–225 (2006)

3. Eur. Urol.58, 270–274 (2010)

Disclosure:

Work supported by industry: no.

135

Levator trauma and subsequent deliveries

Friedman Barhum, T 1 ; Fernandez, A 1 ; Subramaniam, N 1 ; Guichard, P 1 ; Robledo, K 2 ; Dietz, HP 1

1: University of Sydney; 2: Clinical Trials Centre, University of Sydney

Introduction: Damage to the pelvic floor muscle (‘avulsion’) is a known complication of vaginal childbirth (1). Its prevalence is reported as 13-36%. Avulsion is a known risk factor for female pelvic organ prolapse and prolapse recurrence, however, it’s effect on subsequent deliveries has not been investigated.

Objective: To determine whether there is an association between levator avulsion / hiatal area with the length of second stage of subsequent vaginal births.

Methods: This is a retrospective review using data obtained in two previous perinatal studies (2,3) conducted in primiparae. Assessments at 36-38 weeks and 2-5 months postpartum included an interview, questionnaires, clinical examination and four-dimensional translabial ultrasound (TLUS) performed in the supine position, after bladder emptying. Offline analysis for the diagnosis of levator ani avulsion and hiatal area on Valsalva (3) was performed blinded to all clinical data.

Results:1148 women took part in the above- mentioned studies, and a total of 871 returned for a postnatal assessment. Of those, 251 women have since had a second vaginal birth (that is, a first vaginal birth followed by a second vaginal delivery). Eighty-two have had a recorded 3rd vaginal delivery and 11 have had a recorded 4th vaginal delivery. Clinical information regarding the different births is summarized in Table 1. Thirty- six of those 251 women had an avulsion diagnosed after the first birth; all had given birth vaginally, and the average hiatal area on maximum Valsalva was 22.2 (range 7.9-52.9) cm2.

  First birth (n=251) Second birth (n=251) Third birth (n=82)
Length of first stage (min, range) 398 (75-1720) 184 (0-1775) 175 (35-1065)
Length of second stage (min, range) 75 (0-336) 16 (0-130) 17 (0-122)
Vacuum delivery 51 (20%) 10 (4%) 1 (1%)
Forceps delivery 23 1 0
Episiotomy 74 8 2
3 rd /4 th degree tear 9 2 0
Birth weight (grams, range) 3480 (2545-4500) 3538 (300-4834) 3610 (2490-4835)
Head circumference (cm, range) 34.6 (31-38) 35 (29.5-38.5) 35 (31.5-38)

Table 1: Delivery data of first and subsequent vaginal births in women with at least one vaginal birth after the index delivery.

Statistics are presented as median (min-max) or n (%).

Table 2 shows the ralationships of both avulsion and hiatal area with the length of second stage. Avulsion has no effect on the length of second stage of subsequent deliverys (p=0.13), however, on average, a mother who has had an avulsion, had a shorter length of second stage by almost 5 minutes (95% CI: 1 min longer to 11 min shorter). For hiatal area, for each 5 cm2 increase in area, the length of second stage decreases by a minute (95% CI: decrease of 3 minutes to increasep=0.27).

Model   N (%) Minutes difference of second stage length, (95% CI) p-value
Avulsion No avulsion present 215 (85.7%) 0 (reference) 0.13
  Avulsion present 36 (14.3%) -4.9 (-10.7 to 1.0)  
Hiatal area Per 5cm2 increase of area - -1.0 (-2.8 to 0.8) 0.27

Table 2: Multivariate models for length of second stage, adjusted for number of deliveries

Conclusions: Avulsion in a first vaginal birth may be associated with a shortened second stage in subsequent vaginal births, but this effect did not reach significance.

References:

1. BJOG 2008 Jul 1;115(8):979-84.

2. BJOG 2010;117(12):1485–92.

3. BJOG 2016;123(6):995–1003.

Disclosure:

Work supported by industry: no.

136

Laparoscopic sacral colpopexy: A retrospective analysis of the subjective and objective outcome in 898 cases

Sawada, Y 1 ; Nomura, M 1 ; Hayashi, T 1 ; Tokiwa, S 1

1: Kameda Medical Center

Introduction:The aim of this study was to evaluate long-term anatomic and functional outcomes of laparoscopic sacral colpopexy (LSC).

Methods: A retrospective study of women undergoing LSC between 2013 and 2017. Objective success rate (POP stageI) was assessed using the pelvic organ prolapse quantification score (POP-Q). Functional outcomes were assessed using the Urogenital Distress Inventory, Defecatory Distress Inventory, and the Incontinence Impact Questionnaire preoperatively and at 6, 12 and 24 months postoperatively. We also evaluated the incidence of postoperative stress urinary incontinence (SUI) and the actual rate of anti-SUI surgery after SUI. The Wilcoxon signed rank test was used to test differences between related samples.

Results: 898 women underwent laparoscopic sacrocolpopexy. The objective success rate was 98.6%, 98.1% and 97.2% at 6, 12 and 24 months. Subjective success rate was 95.1%, 92.2% and 88.6%. 24.5 % patients reported the symptom of SUI (subjective SUI) postoperatively. Actually, 5% of the whole patients underwent anti-SUI surgery.

Conclusions: Laparoscopic sacral colpopexy provides excellent total support and good functional outcome 2 years postoperatively.

Disclosure:

Work supported by industry: no.

137

A pilot study on using patient reported voiding ability for Trial of Void (TOV) purpose following Pelvic Organ Prolapse (POP) surgeries

Karmakar, D 1 ; Lim, Y 1 ; Dwyer, PP 2 ; Nikpoor, P 1 ; Murray, C 2 ; Thomas, E 1

1: Mercy hospital for women; 2: Mercy Hospital for Women

Introduction: Trial of void (TOV) following POP & Stress Urinary Incontinence (SUI) Surgeries usually involve estimation of post-void residual (PVR) bladder volumes with either ultrasound or in/out catheterization. Recent studies on patients undergoing mid-urethral slings (MUS) have suggested that successful TOV can be predicted if patients reported that their Force of Urinary Stream (FOS) ratio was greater than 0.5 of what they experienced pre-operatively [1,2]. However, it is not known if same could be applied to patients undergoing more extensive POP surgeries.

Objective: To establish feasibility of performing a trial comparing patient reported voiding ability versus more labor-intensive ultrasound/catheter estimation of PVR for TOV following POP surgeries.

Methodology: Prospective study including patients >18 years age undergoing POP +/- SUI surgeries at a single centre in Australia. Exclusion Criteria: Neurogenic voiding dysfunction/atonic bladder, urodynamic detrusor underactivity, intra-operative urological injury, untreated constipation, patients undergoing sling division. Subjective evaluation of voiding ability assessed by asking patients to compare their pre- and post-operative Force of Stream (FOS) and Visual Analog Score (VAS) of Bladder Emptying Satisfaction (BES). We then compared the outcomes of patients TOV based on standard trial of void (S-TOV) protocol that assesses voided volume and PVR with ultrasound. An attempt was then made to find out if there is a cut-off of FOS and BES which can be safely used to predict TOV failure and need for catheterization.

Pre-operative Assessment:

1) Subjective complaints- weak stream/incomplete emptying /bladder fullness /interrupted stream.

2) VAS score for force of (urinary) stream(FOS) on a score of 0-10

3) VAS score for BES (how satisfying the bladder emptying is) on a score of 0-10

4) Uroflowmetry and PVR on ultrasound

Post -operative assessment:

Voided volumes, PVR estimation by ultrasound, subjective FOS and BES VAS. FOS assessment will be expressed as the ratio of post-operative FOS divided by pre-operative FOS. Participants were interviewed preoperatively and 2 days, and 6 weeks postoperatively.

Results: At time of submission follow up was complete for 30 patients (target n=35).While voiding difficulty symptoms improved at 6 weeks post operatively in the group , uroflowmetry parameters did not significantly change postoperatively.8 patients needed re-catheterization (26.67%) and 2 needed CISC > 4 weeks (6.67%). FOS ratio and BES during hospital stay correlated with moderate strength with r(Pearson) value 0.61 (p<0.05). Significant residual needing re-catherisation was defined as PVR of 300 ml or voided volume < one –third of total bladder volume.

On ROC analysis AUC for FOS ratio is 0.92 and for BES is 0.99 , P<0.0001(highly significant in both).

A score of 0.305 (post op FOS/pre op FOS) or less detected significant residual 93 % of patients.

A BES score of 3 or less detected a significant residual in 90 % of patients.

figurebi

Fig 1:ROC analysis

Conclusions: Despite the limitation of a small sample size, this pilot study has actually shown that using patient reported voiding function could potentially be used as an alternative to PVR estimation with ultrasound/catheter after POP surgery .It would likely be worthwhile conducting larger studies to confirm this.

Disclosure:

Work supported by industry: no.

138

Is the older perineum a safer perineum: risk factors for anal sphincter injury

Nolan, C 1 ; O'Leary, B 1 ; Ciprike, V 1

1: Department of Obstetrics and Gynaecology, Our Lady of Lourdes Hospital, Drogheda

Introduction: Obstetric Anal Sphincter Injuries (OASIs) are a severe form of perineal trauma that can occur following vaginal delivery. Sphincter injury following childbirth is the most common cause of anal incontinence, and drastically impacts quality of life1. Perineal support, mediolateral instead of midline episiotomy, and vacuum rather than forceps delivery reduce the risk of OASIs1,2. Identifying other risk factors may facilitate change in labour and delivery practice, potentially reducing the risk of OASIs.

Objective: To identify maternal, fetal, and intrapartum risk factors for OASIs in a regional hospital.

Methods: We conducted a retrospective analysis of vaginal deliveries over a 10-year period (2008 – 2017) in a regional hospital. Anal sphincter injury was diagnosed by an experienced clinician and classified according to RCOG recommendations. A multiple logistic regression model was created using the presence of OASI as the dependent variable. Coefficients were adjusted for relevant maternal, fetal, and intrapartum risk factors. Statistical analysis was performed using R 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).

Results: During the study period there were 23,887 vaginal deliveries in our unit. Of these, 18,550 were spontaneous (77.66%), 3,746 were vacuum-assisted (15.68%), 1,196 were forceps (5.01%) and 395 were sequential instrumental deliveries (1.65%). The overall rate of OASIs was 1.76% (421/23 887).

Significant maternal factors that increased the risk of OASIs on regression analysis were primiparity (OR 2.1, CI 1.67 – 2.62, p < 0.001) and Asian ethnicity (OR 2.26, CI 1.40 – 3.46p < 0.001). Maternal age ≥ 35 decreased the risk of OASI (OR 0.68, CI 0.50 – 0.92, p = 0.013).

Increased risk of sphincter injury was associated with a fetal birthweight between 3500g - 4000g (OR 1.62, 95% CI 1.27 – 2.06 p < 0.001) and >4000g (OR 1.77, CI 1.31 – 2.37 p < 0.001), though there was no significant difference between these groups. Forceps delivery (OR 4.8, CI 3.27 – 7.02, p < 0.001), sequential instrumental delivery (failed vacuum proceeding to forceps, OR 5.87, CI 3.61 – 9.37, p < 0.001) and shoulder dystocia (OR 1.91, CI 1.16 – 2.99, p < 0.001) were significant intrapartum risk factors. Vacuum delivery did not significantly increase the risk of OASI (OR 1.26, CI 0.90 – 1.76, p = 0.173)

Conclusions: A number of maternal, fetal and intrapartum variables were found to increase the risk of OASIs. The greatest increase in risk was seen with forceps delivery and sequential use of instruments. In our population, maternal age over 35 years confers a protective effect after adjusting for parity, birthweight, and mode of delivery. Further research is required to investigate the impact of maternal age on anal sphincter injury.

Table 1: Multiple logistic regression model comparing mothers with obstetric anal sphincter injury to those with an intact sphincter.

figurebj

1. Naidu M, Sultan AH, Thakar R. Reducing obstetric anal sphincter injuries using perineal support: our preliminary experience. Int Urogynecol J. 2017 Mar;28(3):381–9.

2. McPherson KC, Beggs AD, Sultan AH, Thakar R. Can the risk of obstetric anal sphincter injuries (OASIs) be predicted using a risk-scoring system? BMC Res Notes. 2014 Jul 24;7:471.

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Work supported by industry: no.

139

The association between urinary incontinence and vitamin D insufficiency in pregnancy

Stafne, SN 1 ; Salvesen, K 1 ; Johannessen, HH 2 ; Syversen, U 1 ; Gustafsson, M 1 ; Stunes, AK 3 ; Mørkved, S 1

1: NTNU / St.Olavs hospital Trondheim University Hospital; 2: Østfold Hospital Trust; 3: NTNU

Introduction: Vitamin D insufficiency is prevalent in pregnancy, and has been related to adverse health effects. The presence of Vitamin D receptors in both striated muscle of the pelvic floor and bladder smooth muscle suggests that Vitamin D could exert influence in the development of urinary incontinence (UI).

Objective: The aim was to assess associations between UI and Vitamin D insufficiency in mid-pregnancy.

Methods: This is a secondary analysis of a randomized controlled trial including 855 healthy pregnant women recruited in pregnancy week 18-22. Blood samples were collected after an overnight fasting, and the sera were stored at -80 °C. The analysis of 25-hydroxyvitamin D [25(OH)D] levels was performed on stored sera. Serum 25(OH)D levels <50 nmol/L were classified as Vitamin D insufficiency. Questionnaires regarding prevalence of UI (Sandvik’s severity index) were completed. Urinary leakage was classified according to the definitions given in the standardised IUGA/ICS terminology of lower urinary tract symptoms. Women confirming any type of urinary leakage were referred to as having UI, and women reporting leakage with activities increasing abdominal pressure were referred to as having stress urinary incontinence (SUI).

Results: Complete data on level of Vitamin D and UI were available for 823 women. Mean age was 30.5 years, and 57% were nulliparous. Vitamin D insufficiency was found in one third of women. More women with Vitamin D insufficiency reported UI (49% vs. 39%, p<0.01) and SUI (36% vs.25%, p=0.001) compared to women with adequate Vitamin D status.

Conclusions: The present findings indicate a possible association between Vitamin D insufficiency and incident UI in otherwise healthy pregnant women. Future studies may evaluate the impact of Vitamin D supplementation on UI.

Disclosure:

Work supported by industry: no.

140

Assessing frailty in women undergoing elective pelvic reconstructive surgery

Zeno, A 1 ; Yazdany, T 2

1: Harbor UCLA Medial Center; 2: Harbor UCLA Medical Center

Introduction: The American College of Surgeons describes frailty as age-related, multi-dimensional states of decreased physiologic reserves. Recent U.S. data finds that 237,000 gynecologic procedures are performed annually in women aged 65 and older. This annual number is expected to grow as the population of U.S. adults over 65 years is expected to double between 2012 and 2050.

Objective: This video reviews frailty assessment in female pelvic surgery patients, with information from FPMRS literature as well as the American College of Surgeons National Surgery Quality Improvement Program (ACS NSQIP), and American Geriatrics Society (AGS). Video objectives: 1) Define frailty; 2) Describe how frailty is relevant for female patients undergoing pelvic surgery; 3) Describe clinic frailty screening and triage for female pelvic surgery providers; and 4) Provide an introduction to frailty diagnosis.

Methods: A review from the National Institutes of Aging Conference, 2015, suggests surgeons perform either 1-minute, 5-minute, or 15-minute frailty screening assessments, which are reviewed in the video. The ACS NSQIP/AGS recommended diagnostic criterion is the Fried Scale.

Results: FPMRS studies support starting to screen preoperative patients for frailty between ages 60-80; the ACS NSQIP/AGS guidelines recommend screening these patients starting at age 65. As frailty is not age dependent, consider assessing frailty in all patients undergoing pelvic reconstructive surgery with concerns for mobility, cognition, or poor nutritional status. Surgical considerations include enhanced recovery pathways to decrease narcotics, “prehabilitation,” surgical approach, postoperative disposition, and postoperative clinic follow up.

Conclusion: Emerging data indicate that frailty impacts outcomes in women undergoing pelvic reconstructive surgery. Frailty screening is an NSQIP measure for all elderly patients undergoing elective surgery. Screening for frailty can allow surgeons to work with primary care providers to optimize patients for surgery.

Disclosure:

Work supported by industry: no.

141

A novel combined transurethral and suprapubic approach for resection of bladder Mesh

Ryu, G 1

1: Hospital Aarau

Introduction: A 68-year-old woman who presented with a 6-month history with irritative voiding symptoms and recurrent urinary tract infections was found to have persistent perforation into the bladder, of a tension-free vaginal tape placed 48 months before. The patient had undergone two previous mesh removals transurethrally at an outside institution. The patient continued to have recurrent urinary tract infections and was referred to our institution. Cystoscopy revealed stone formation and persistent mesh perforation.

Objective: To achieve radical excision, a novel combined transurethral and suprapubic approach was planned.

Methods: Following general anesthesia the patient was prepared in the dorsal lithotomy position. A cystoscope was inserted transuretherally and the bladder was filled with normal saline. Two suprapubic punctures were next carried out and 3.5-mm trocars were inserted into the bladder under direct cystoscopic vision. One surgeon used a 3.5 mm camera optics and a 3.5 mm grasper from the suprapubic side to pull on the stone and the perforated mesh, while the other surgeon used scissors transurethrally to resect the mesh and stone. At the end of the procedure, we left a Foley catheter with continuous lavation.

Results: The patient’s postoperative course was uneventful. At 1-month follow-up, the patient was asymptomatic and cystoscopy revealed partial healing of the mesh site. At 6-month follow-up, the patient continued to be asymptomatic and cystoscopy demonstrated complete healing of the mesh site. No further mesh erosion was present.

Conclusion: This combined transurethral and suprapubic maneuver allowed for adequate tension on the perforated mesh enabling to be removed adequately. Additionally the use of two cameras allowed for better visualization in locating the perforation and adequately removing it. The suprapubic camera adds additional spatial orientation and ease that leads to removal of the perforated mesh in its entirety at the challenging location of bladder neck and bladder base region. This novel technique provides an effective means of radically removing a mesh perforated into the bladder using a combined transurethral and suprapubic approach.

Disclosure:

Work supported by industry: no.

142

Information and Communication Technologies (ICT) self-management system for pelvic floor muscle training: A pilot study in women with stress urinary incontinence

Anglès Acedo, S 1 ; Kastelein, AW 2 ; Ros Cerro, C 1 ; Raatikainen, K 3 ; Alonso Lopez, JF 4 ; Pagès Raventos, A 4 ; Vodegel, EV 2 ; Airaksinen, O 3 ; Espuña Pons, M 1

1: Hospital Clínic de Barcelona; 2: Academic Medical Center; 3: Kuopio University Hospital; 4: Universitat Politècnica de Catalunya

Introduction: Information and Communication Technologies (ICT) applied to healthcare systems can increase the accessibility to treatments, empower patients and healthcare workers and invest in research towards the personalized medicine of the future. E-Health tools for urinary incontinence (UI), scientifically evaluated, could provide an effective and widely accepted treatment.

Objective: The main objective of this pilot study is to perform a thorough test of the functionality of the ICT self-management system in order to analyze its technical readiness, for clinical use and research purposes. The video will show all the components of the ICT-system and how it works.

Methods: 21 women, between 18 to 75 years old, with mild or moderate stress urinary incontinence (SUI) according to their answers to the UDI-6 and ICIQ-UI-SF questionnaires, were recruited in two European University Hospitals. All patients received information about all treatments options for SUI and accepted to be treated with conservative treatment. Informed consent was obtained for using the ICT self-management system for pelvic floor muscle training (PFMT) at home during three months.

This system integrates: 1) Portable vaginal biofeedback device and abdominal belt with surface electromyography (EMG)-sensors to collect data on patient’s pelvic floor and abdominal muscle activity; 2) Smartphone with application and serious games, designed specially to facilitate and support conservative treatment for SUI; 3) A web portal to remotely supervise the sessions adherence, to monitor progress and to communicate with patients.

All patients performed a training program designed by a therapist. During the treatment, patients reported clinical and technical issues, related to the ICT self-management system and filled out specific questionnaires to evaluate functionality and usability of the system based on their experience.

Results: 21 women were included, age ranging from 32 to 67 years (median 45) with a median BMI of 23 kg/m2, a median parity of 2 and a median ICIQ-UI-SF of 11 (IQR 9-12). None of the patients reported problems regarding the use of the ICT self-management system. There were six dropouts, three for technical issues and three for personal reasons (non-medical). The 15 patients who completed the treatment had an adherence of 70,4% (range 41,8-86,2%). During this evaluation of the systems’ functionality, we observed different minor technical issues mainly related to software calculations and fatigue of the materials used in the prototype. All issues were resolved, which consequently improved the system. Only minor clinical events occurred (vaginitis, urinary infection). However, despite the technical issues, most patients (80%) were pleased or very pleased with the ICT self-management system.

Conclusions: Overall, the ICT-self-management system performed well in usability testing and guarantees good adherence to PFMT. In addition, it helps therapists to monitor their patients and communicate with them. Different minor technical issues were detected. All issues were resolved and their detection resulted in improved functionality of the ICT self-management system. Clinical issues related to treatment were minimal and similar to other vaginal devices.

Technical teams are implementing all improvements in order to develop the definitive ICT self-management system, which will be evaluated in a randomized clinical trial.

Disclosure:

Work supported by industry: no.

143

Perineal hernia repair using permanent suture and Mesh

Avondstondt, A 1 ; Salamon, C 1 ; Ezzedine, D 2

1: Atlantic Health System; 2: Maimonides Medical Center

Introduction: A perineal hernia is the uncommon, abnormal protrusion of intra-abdominal structures, such as the small bowel or colon, through a defect in the levator plate into the perineal area. Asymptomatic patients with perineal hernias may choose observation but symptomatic patients typically require surgical intervention. Due to the rarity of this condition, the ideal surgical approach to perineal hernia repair has not been established with successful abdominal, transperineal, or combined routes reported.

Objective: We present the case of a posterior perineal hernia repaired robotically using permanent sutures and mesh. A concomitant supracervical hysterectomy and colpopexy was performed.

Methods: This video presentation reports a 67-year-old woman presenting to our office with worsening bulge symptoms. Her history was remarkable for 4 vaginal deliveries, 1 cesarean section, and posterior repair 14 years prior. On examination, a large left-sided perineal hernia containing small bowel was found in addition to stage 3 uterovaginal prolapse. A minimally invasive robotic-assisted abdominal approach was chosen for repair. Upon entry into the abdominal cavity, a 4 cm left-sided levator defect was noted with a 6 cm hernia sack in contact with perineal skin. The small bowel content was easily reduced, the hernia sack excised and the defect closed with permanent polytetrafluoroethylene suture. The posterior arm of the sacrocolpopexy mesh was used to reinforce the hernia repair. A supracervical hysterectomy and sacrocolpopexy were performed concomitantly to treat the uterovaginal prolapse.

Results: At 14 month follow up, the patient was doing well and symptom-free. Robotic-assisted surgical repair of this perineal hernia offered excellent intra-operative visualization and complete delineation of the defect with clear visualization of surrounding pelvic structures.

Conclusions: Perineal hernias are a rare cause of pelvic bulge symptoms in women. In the appropriate candidate, robotic-assisted abdominal approach including excision of the hernia sac and defect closure using permanent suture with mesh offers patients a safe and effective method for perineal hernia repair. Increased reporting in urogynecology literature may help guide optimal treatment for practitioners.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Boston scientific consultant; Intuitive surgical, Inc. consultant).

144

Urodynamic: Visual library

Sandor, C 1 ; Fonseca, C 1 ; Pavan, L 1 ; Soderini, H 1 ; Ubertazzi, E 1

1: Hospital Italiano Buenos Aires

Introduction: Urodynamic study (UDS) includes a series of tests which are designed to evaluate the function of the lower urinary tract (LUT), providing functional information on bladder storage and voiding. The main objective of UDS is to reproduce the patient's symptoms and determine the origin of LUT disorders.

According to the International Continence Society (ICS), the standard urodynamic test should include uroflowmetry with evaluation of post void residual volume, transurethral cystometry and pressure-flow study1.

Currently UDS is frequently used in patients with stress urinary incontinence (SUI) and urgency urinary incontinence (UUI) refractory to medical treatment, as well as in cases of mixed urinary incontinence, voiding disorders and patients with pelvic organ prolapse prior to surgical correction2.

The UDS represents a useful ancillary tool to evaluate the pathophysiology of LUT symptoms, as well as to improve the therapeutic approach.

Objective: The aim of the video is to display a visual library of the various normal and pathological urodynamic findings in patients complaining of LUT disorders.

Methods: We retrospectively reviewed the UDSs performed at the urogynecology section of a third level University Hospital from January 2015 to December 2017, where we documented the normal parameters as well as LUT disorders. The findings were classified according to the phase in which they are assessed: storage or voiding.

Results: One thousand UDS performed between January 2015 and December 2017 were evaluated, normal and altered parameters were registered.

We considered UDSs with different normal findings during storage phase and during the pressure/volume study, different mechanisms of micturition are also shown, such as contraction of the detrusor muscle, abdominal contraction and relaxation of pelvic floor muscles.

We documented changes in cystometry such as phasic or terminal involuntary detrusor contractions that may or may not be associated with UUI. We show the urodynamic findings compatible with SUI and mixed urinary incontinence. Cystometric alterations such as loss of compliance and urethral instability are also shown.

Regarding the voiding phase, alterations such as bladder outlet obstruction and detrusor-sphincter dyssynergia are shown in the pressure-flow studies.

Conclusions: The visual library shows the main urodynamic findings of patients with LUT disorders, which we believe are useful for personnel in training or at centers where the surgeon does not perform UDSs.

The UDS is an ancillary study that complements the anamnesis and physical examination of the patients with LUT alterations, allowing a documentation of the disorder's origin and determine the appropriate treatment.

1 Neurourology and Urodynamics 2017; 36(5):1243-1260

2 International Urogynecolgy Journal 2010; 21:5–26

Disclosure:

Work supported by industry: no.

145

Laparoscopic urethrolysis for urethral obstruction after Burch colposuspension for stress urinary incontinence: Cases reports

Sardi, J 1 ; Prieto, J 2 ; Maya, G 2

1: Hospital Britanico ; 2: Hospital Britanico

Introduction: Urethral and bladder outlet obstruction (BOO) is a recognized complication after most surgical procedures for stress urinary incontinence. The mechanisms involved are thought to be related to an overcorrection of the urethra (kinking and/or compressing the urethra) or excessive scar formation between the pubis and urethra. The recommended treatment is usually surgical that aims to free up the obstructed urethra (urethrolysis). For retropubic bladder neck suspension (BNS) or Burch surgery, laparoscopic surgery offers a less invasive alternative to classical abdominal approach. We report methods and results of performing lap urethrolysis in patients with urethral obstruction after Burch colposuspension.

Objective: The aim is to report the feasibility of performing the laparoscopic approach in these patients

Methods: Four patients presented with voiding difficulties, urinary irritative symptoms and urinary infections after Burch colposuspension. BOO was diagnosed based on history, presenting symptoms, and urodynamic findings, including the maximum flow rate (Qmax) of ≤12 mL/second and detrusor pressure at maximum flow (PdetQmax) of ≥20 cmH2O and in one case complemented with pelvic floor ultrasound. Patients underwent laparoscopic assisted urethrolysis, which consisted of the usual lap exposure of the abdominal cavity, access to the space of Retzius, removal of Burch sutures (when they were find),or scar tissue and hypermobilization of the urethra. The intraoperative and postoperative complications, recovery time, and outcome of the procedure to successfully address the patient’s symptoms were reviewed.

Results: Postoperatively, the 4 patients had complete resolution of the obstructive and irritative symptoms. All had improvement of the postvoid residual volume with a median of 30 mL (range 0-64 mL). Postoperatively, urodynamic studies were repeated in two patients and Pdet and the Qmax decreased from 44 cmH2O before surgery to 22 cmH2O and from 39 to 21 cmH2O, respectively. Qmax increased from 6 to 24 mL/second and from 3 to 18mL/second, respectively. This two patients reported stress urinary incontinence in the postoperative period, both in treatment with pelvic floor biofeedback. No patients reported intra o postoperative complications. All of them where discharged 24 hours postop. The average surgery time was 63 minutes.

Conclusions: Lap assisted urethrolysis is a feasible and attractive minimally invasive procedure to treat BOO after Burch surgery.

Disclosure:

Work supported by industry: no.

146

Mesh apical prolapse surgery under local anaesthesia

Halaska, M 1 ; Maxova, K 2 ; Lincova, M 2

1: Charles University; 2: Charles University

Introduction: Increasing life expectancy of our patients means the higher prevalence of surgery for vaginal prolapse. This pathology requieres special access with respect to the local tissues, special operation techniques, sparing medication; resulting in early verticalisation. That all offers the local anaesthesia.

Objective: To present the techniques of vaginal repair of advanced pelvic organ prolapse including mesh suspension of central compartment under the local anaesthesia.

Methods: Since 2011 we use local anaesthesia with diluted artican+epinephrine offering this sparing method to all the patients who are willing to cooperate. Among the arguments we present are: sparing technique, less bleeding, shorter operation time and quick recovery with less painkillers, with no or low pain scores.

Results: So far we have used this type of anaesthesia - with negative or low scores of VAS- in 356 patients. Lately, we decided to use local anaesthesia also in central repair anchoring the mesh in sacrospinous ligaments. Our presentation includes central mesh suspension video.

Conclusions: Local anaesthesia in vaginal surgery approved to be a feasible method shortening the operation time, minimizing blood loss and sparing the cognitive functions in our young and geriatric patients.

Disclosure:

Work supported by industry: no.

147

A laparoscopic technique for excision of retropubic midurethral sling arms eroding into the bladder

Stratta, E1; Cartwright, R1; Goodall, L1; Arshad, I1; Jackson, S1; Price, N1

1: Oxford University Hospitals NHS Trust

Introduction: Midurethral polypropylene slings have a range of uncommon but serious complications including erosion into the bladder. Women with mesh eroding into the bladder may present with pain, haematuria, or recurrent UTI. Cystoscopic approaches for removal of eroding mesh, including use of cystoscopic trimming, or holmium laser ablation, carry a high risk of recurrence of erosions. Cases series have described vesicoscopic approaches to bladder mesh erosions with incision at the dome[1,2]. These approaches provide good exposure for mesh erosions close to, or within the trigone, but retropubic slings typically erode more laterally. Cystotomy at the dome allow removal of intraluminal and submucosal mesh but leaves the intramural portion of the mesh.

Objective: We demonstrate in this video a modification of these techniques for retropubic slings that can be used for total laparoscopic excision of an eroding sling without cystotomy at the dome.

Methods: After placing ureteric stents, the bladder is instilled with 300mls of normal saline with methylene blue, to help delineate the dome of the bladder. With the patient in Trendelenberg position the retropubic space is opened using a monopolar hook at 2cm above the bladder reflection. The space of Retzius is developed, and the bladder is reflected down bilaterally to expose the urethra and sphincter complex in the midline, and the obturator vessels and nerves bilaterally. The arms of the mesh can then be identified, and the relation of the mesh to the important structures in the retropubic space can be assessed at this stage. Under traction the mesh can be sharply dissected out from the surrounding structures. This can be continued down to the level of the bladder. The cystotomy is then made where the sling erodes into the bladder. The cystotomy is closed in two layers using a polyglactin suture. An indwelling catheter is left for two weeks to allow bladder healing, with a cystogram performed prior to the catheter removal.

Results: We identified 6 women undergoing this procedure at a median 45 months post midurethral sling insertion. The procedures took a median 112 minutes (excluding one patient with bilateral erosion and bilateral cystotomy: 240 minutes). There were no early complications, and no cases returned to theatre. We followed up all patients with a questionnaire at minimum 24 months post surgery. For the four patients with pre-operative pain associated with the mesh, there was a median 7 point decrease in pain (10 point scale). For two women where the suburethral portion of mesh was left in situ, there was recurrence of erosion, whereas for the four women with complete sling removal there was no further erosion.

Conclusion: Our series confirms the feasibility of this technique [3], with advantages over cystoscopic or open approaches. These include precise dissection under direct vision, which gives better exposure and identification of anatomical structures, and the opportunity for a complete excision to prevent recurrence without risk of creating a fistula.

1.Int Urogynecol J22, 1593–1595 (2011).

2.Urology102, 247–251 (2017).

3.JSLS10, 220 –225 (2006)

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Figure 1a to d: Laparoscopic excision of mesh eroding into the bladder. a) a cystotomy is made where the tape breaches the bladder wall b) the tape is completely freed from the bladder using scissors c) the cystotomy is sutured in two layers with polyglactin suture d) a check for watertight closure is made

Disclosure:

Work supported by industry: no.

148

Tips and tricks improving surgical efficiency at time of laparoscopic native tissue repair for pelvic organ prolapse and stress urinary incontinence

Lachance, C1; Gangal, M1; Walter, JE1

1: McGill University Hospital Center (MUHC)

Introduction: Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) coexist in up to 80% of women with pelvic floor dysfunction. While commonly in use, surgical meshes for the treatment of POP and SUI can lead to complications not necessarily encountered in native tissue repair. Furthermore, many patients hear of litigious claims against mesh products and are afraid to undergo surgery using these products. Therefore, more patients are asking to use their own tissues to correct their symptoms. In our institution, we offer these young patients a laparoscopic uterosacral suspension, a paravaginal defect repair, and a Burch colpourethropexy. Evidence suggests that laparoscopic uterosacral ligament hysteropexy is safe and effective, but different techniques are accepted among experts. The Burch colpourethropexy is a well studied procedure to correct SUI and the laparoscopic approach has shown equivalent efficacy in medium follow-up randomized trials compared to its open counterpart. While being minimally invasive, these can prove to be time-consuming surgeries.

Objective: The purpose of this video is to present tips and surgical techniques that improve efficiency and ergonomics in the context of laparoscopic uterosacral ligament hysteropexy, paravaginal defect repair, and Burch colpourethropexy.

Methods: This is a video of a fellowship-trained urogynecologist and fellows in Female Pelvic Medicine and Reconstructive Surgery performing native tissue laparoscopic surgery. The presented surgery is a laparoscopic approach to an uterosacral ligament hysteropexy, a bilateral paravaginal defect repair and a Burch colpourethropexy. The patient received antibioprophylaxis, thrombophylaxis and a general anesthesia. Four trocars were used (10 mm umbilical with 0-degree laparoscope, two 5 mm on the left side, and a 12 mm in right lower quadrant).

Results: We propose four techniques to improve the efficiency of the surgery:

1) A continuous suture is used to repeatedly plicate each uterosacral ligament and fixate it to its cervical insertion point (instead of interrupted sutures).

2) The repair of the paravaginal defect is performed using a running barbed suture (instead of interrupted sutures).

3) The sutures for the Burch colpourethropexy are passed through contralateral separate trocars (improves ergonomics and decreases tangling).

4) A running suture and intracorporeal knot tying are used for closing the peritoneal incision (avoiding the use of barbed suture on peritoneum and time consuming interrupted sutures).

Combination of these surgical techniques decreases operative time and increase efficiency, likely without compromising surgical outcomes.

Conclusions: Laparoscopic uterosacral hysteropexy, bilateral paravaginal defect repair, and Burch colpourethropexy are minimally invasive surgical techniques that can be used to correct POP and SUI on patients who desire hysteropreservation but refuse use of any mesh material. We expect that that the surgical time will be reduced compared to traditional methods, without compromising surgical outcomes. Further studies with a comparison group will be needed to confirm this.

Disclosure:

Work supported by industry: no.

149

Pudendal neuralgia – a urogynecological approach

Masata, J 1 ; Svabik, K 1 ; Hubka, P 1 ; Martan, A 2

1: Charles University, First Faculty of Medicine and General University Hospital Prague; 2: Petr Hubka &lt;petr.hubka@centrum.cz&gt;

Introduction: Pudendal neuralgia is a rare condition which is often not properly diagnosed. Unfortunately most patients with this condition seek answers from their physicians in vain as to the cause. The diagnosis is frequently mistaken, and they may undergo inappropriate or unnecessary surgery or be referred to psychiatry because examination is unable to diagnose the condition. Pudendal neuralgia as defined in the ICS/IUGA terminology report is vaginal or vulval burning pain (between the anus and clitoris) associated with tenderness of the pudendal nerves. Five essential criteria (Nantes criteria) have been proposed: (a) pain in the anatomical region of pudendal innervation, (b) pain that becomes worse with sitting, (c) no waking at night with pain, (d) no sensory deficit on examination, and (e) relief of symptoms with a pudendal block. We can form a diagnosis based on history taking and excluding other causes such as infection, tumor etc. No clinical examination is able to diagnose pudendal neuralgia clearly.

Objective:The objective of this work is to present a typical patient with pudendal neuralgia with the complex possibilities of the treatment and a video presentation of laparoscopy surgical pudendal nerve decompression.

Methods: Case presentation: a 55-year-old women (G2/92, height 170 cm, weight 70 kg) was referred to our department with chronic vulvovaginal discomfort, following repeated urogynecological procedures. She complained of pressure pain around the pubic bone, vulvar itching, a tingle in the lower abdomen; the discomfort appeared after her second delivery. The discomfort eased at rest and worsened with movement. Walking induced urgency, and walking upstairs induced pain. She had increased frequency (15 per day), urgency incontinence, no nocturia, and stress urinary incontinence with fecal incontinence. In 2011 she underwent retropubic TVT without any effect; in 2013 she received transobturator tape which worsened the tingling sensation and pelvic pain, followed by tape removal at a specialized urogynecology center in 2014. In 6/2015 she underwent laser therapy, without any effect, and in 8/2015 laparoscopy assisted vaginal hysterectomy with posterior vaginal wall repair. She repeatedly received antibiotic treatment for E. coli in the vagina, without any effect.

Results: Clinical examination revealed palpable pain along the pudendal nerve; pressure on the nerve induced the pain described by the patient. Palpation exam also reveal hypertonus of m. ilecoccygeus, bilateral avulsion of puborectalis muscle and slightly painful os coccyges and rectocoelae. Ultrasound indicated the presence of anal sphincters defect. Urodynamics established stress urinary incontinence and bladder oversensitivity with decreased capacity. Following a pudendal block there was immediate relief of the pain. 3T MRI revealed hypertrophy of the right pudendal nerve. These findings indicated surgical pudendal nerve decompression surgery. The video shows this surgical procedure step by step. Surgery produced significant relief of the discomfort (using the VAS there was 80% improvement). Controlled urodynamics established persistence of stress urinary incontinence and normal filling cystometry.

Conclusions: Pudendal neuralgia is seldom properly diagnosed and treated. For some patients with suspected pudendal nerve entrapment syndrome, pudendal nerve decompression surgery is appropriate and can bring relief in up to 70% of cases.

Disclosure:

Work supported by industry: no.

150

Laparoscopic treatment of intrapelvic entrapment of sacral nerve roots by abnormal piriformis bundles causing sciatica, pudendal neuralgia, and pelvic floor dysfunction

Li, A1; Polesello, G2; Tokechi, D3; Cancelliere, L1; Sermer, C1; Lemos, N1

1: Functional Pelvic Surgery and Neuropelveology, Department of Obstetrics and Gynecology, University of Toronto; 2: Division of Hip Surgery, Department of Orthopedics and Tramatology, Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo, Brazil; 3: Division of Musculoskeletal Imaging, Department of Radiology, Hospital Sirio-Libanes, Sao Paulo, Brazil

Introduction: First described in 1937, piriformis syndrome is caused by these abnormal variations of the piriformis muscle compressing the sciatic nerve, leading to pain in the buttocks, hips, and/or lower limbs. It accounts for 5-6% of sciatica and can be challenging to both diagnose and cure.

Objective: We present a video of a case of a right-sided intrapelvic entrapment of sacral nerve roots by the piriformis and review our initial results.

Methods: A 36 year-old man was seen with a 8-month history of moderate sciatica, describing aching pain in the gluteal region and sharp pain in the lower limbs. Hip abduction aggravated the pain, while ambulating alleviated his symptoms. He denied erectile dysfunction. Associated urinary symptoms were frequency, urgency, and urge incontinence. Regular medications included pregabalin 75 mg twice daily and dipyrone 1 g every six hours. Past medical history included dyslipidemia. Examination revealed allodynia in the proximal scrotum, along the S2 dermatome. Urodynamic investigations suggested urinary incontinence due to detrusor overactivity. Magnetic resonance imaging showed an anomalous piriformis bundle compressing L5 to S2 nerves.

Results: Laparoscopy was performed under general anesthesia. After developing the pre-sacral space, an anomalous piriformis muscle bundle compressing the S2 and S3 nerve roots was observed. The muscle fibres were divided, and the right sacral nerve roots then revealed. The previously divided muscle fibres were then mobilized to retract into the deep gluteal space.

Post-operatively, the patient reported full resolution of his urinary and motor symptoms. However, generalized sciatica occurred at 6 weeks post-operatively due to the retraction of the distal portion of the transected piriformis muscle into the deep gluteal space, which fibrosed and adhered to the sciatic nerve at that level. A second operation was ultimately required, utilizing a transgluteal approach to detrap the sciatic nerve.

Three additional patients underwent a similar operation. Of four patients, the average age was 42.5 ± 11.7 (36 – 60) years, and three (75%) were female. The average time from symptom onset to diagnosis was 6.2 ± 6.2 (0.7 – 15) years, and patients had undergone 1.8 ± 2.1 (0 – 4) surgeries. Prior to our surgery, the VAS score was 9.3 ± 1.0 (8 – 10); however, post-operatively, this decreased to 2.0 ± 1.8 (0 – 4). The average surgical time was 119 ± 39.5 (66 – 161) minutes. None of the other three patients experienced recurrent symptoms or required a second transgluteal approach.

Conclusion: Intrapelvic entrapment of sacral nerve roots by abnormal piriformis muscle bundles is a possible extra-spinal cause of sciatica and neurogenic pelvic floor dysfunction that can be treated successfully by laparoscopy.

References:

  1. 1)

    Beaton LE and BJ Anson. 1937. The Relation of the Sciatic Nerve and of its Subdivisions to the Piriformis Muscle. The Anatomical Record 70:1-5.

  2. 2)

    Possover M, Quakernack J, Chiantera V. 2005. The LANN Technique to Reduce Postoperative Functional morbidity in Laparoscopic Radical Pelvic Surgery. J Am Coll Surg 201:913-7.

Disclosure:

Work supported by industry: no.

151

A Cost-Effective, Reproducible and Novel Vaginal Hysterectomy Model

Alsaden, I1; Rugino, A1; Senapati, S2; Iyer, S3; Botros, C3

1: University of Chicago Medicine; 2: NorthShore University HealthSystem; 3: University of Chicago/NorthShore University HealthSystem

Introduction: Vaginal hysterectomy (VH) has been associated with better outcomes and fewer complications compared to other routes of hysterectomy. The vaginal route is the preferred choice for benign hysterectomy, as recommended by the American College of Obstetrics and Gynecology1. However, as laparoscopic hysterectomy has become more common, numbers of VHs have decreased, with half of obstetrics and gynecology residency graduates completing 18 or fewer VHs as the primary surgeon. Studies have demonstrated that residents require 21 VHs to become competent2. Surgical models and use of simulation can improve residents’ comfort level with VH, but realistic and cost-effective models for VH are lacking1.

Objective: We aim to create a novel, cost-effective and reproducible VH model, which will be utilized in a surgical skills curriculum for obstetrics and gynecology residents.

Methods: To assess the need for an adjunct to resident surgical training for VHs, a questionnaire was sent to residents at an academic medical center, which evaluated their comfort level with performing a VH. After reviewing the results of the survey, a VH model was created using materials found at craft or hardware stores. A 4” to 6” rubber plumbing joint was mounted to a board and used as a reusable pelvis. Holes were drilled in appropriate locations in order to attach a uterus and bladder (balloon filled with water) within the pelvis (figure 1). The rectum was a two-layer tubular structure made from cotton quilt batting for serosa and wefting for mucosa. A uterus was hand sculpted from clay and then cast into a reusable silicone rubber mold. Pourable foam was placed in the mold to create copies of uteri that were attached to the pelvis using a series of rubber bands as ligaments. Press and seal was used to simulate peritoneum. The focus of the model was to simulate the essential elements of a VH: demonstrate the underlying pelvic anatomy, proper placement of clamps, and tying secure square knots vaginally (figure 2). A video was created to show the steps of model creation and use of the model to perform a VH.

Results: Only 20% of residents felt “comfortable” performing a VH, while 65% felt either “uncomfortable” or “very uncomfortable”. The cost of 60 models was approximately $500. The initial investment for reusable materials and silicone rubber mold materials was $300. The cost per foam uterus and other disposable materials was between $2.50-$3.00.

Conclusion: This vaginal hysterectomy model provides a realistic model and will improve resident comfort level with VHs in a cost-effective manner. With increasing opportunities to practice VHs in a safe and controlled simulated environment, residents may graduate feeling more comfortable independently performing the VH.

Figure 1: Reusable Pelvis and Placement of Organs

figurebl

Figure 2: Proper Clamp Placement

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References

  1. 1.

    Committee on Gynecologic Practice. Committee Opinion No 701: Choosing the Route of Hysterectomy for Benign Disease. Obstet Gynecol. 2017;Jun;129(6):e155-e159.

  2. 2.

    Washburn EE, et al. Trends in reported resident surgical experience in hysterectomy. J Minim Invasive Gynecol. 2014;21(6):1067-70.

Disclosure:

Work supported by industry: no.

152

A Danish national population-based cohort study of synthetic midurethral slings, 2007-2011

Hansen, M 1 ; Lose , G 2 ; Bóel Sigurdardòttir, H 2 ; Oren Gradel, K 3

1: Nordsjællands hospital, Department of Obstetrics and Gynaecology, ; 2: Herlev and Gentofte Hospital,Department of Obstetrics and Gynaecology; 3: Center for Clinical Epidemiology, Odense University Hospital and Research Unit of Clinical Epidemiology

Introduction: The synthetic midurethral slings (MUSs) have shown similar cure rates in several short-and medium term follow-up studies. Recently, long-term follow-up studies indicate that the objective cure rate is higher following tension-free vaginal tape (TVT) compared to the transobturator tape (TOT). In several countries, it is the generally accepted practice to use either TVT or TOT. The question is whether the patient is part of a shared decision-making or the choice is left to the surgeon or the department. Previous studies have shown that both department and surgeon volume affect the outcome of synthetic MUSs. The learning curve for TVT is well- documented, whereas this is poorly reported for TOT.

Objective: The objectives of the present study were: i) to evaluate the efficacy of synthetic MUSs on patient reported outcome measures based on a national population over a 5-year period ii) to describe the influence of department and surgeon volume on the use of either TVT or TOT; and iii) to examine the influence of department and surgeon volume, and patient-related factors on the cure of synthetic MUSs.

Methods: Data from the Danish Urogynecological Database (DugaBase) were linked to the Danish National Patient Registry, and the Danish National Prescription Registry. Logistic regression predicted odds of cure (leakage once a week or less often) pertaining to surgeon and department volume on Incontinence Questionnaire-Short Form (ICIQ-SF) (frequency of urinary incontinence (UI), amount of leakage, and impact of UI). Adjustment was made for several patient-related factors. We divided department volume into high volume departments (the five largest departments in Denmark, one in each region) and the remaining departments. Surgeon volume was categorized according to number of synthetic MUSs during the career as a surgeon(low (≤ 25), medium (26-75), and high volume (>75)).

Results: A total of 4519 women with first-time MUS were registered in the DugaBase. Cure was achieved in 1242/1639 (75.8%) at three months’ follow-up (Figure 1). The synthetic MUSs were performed at 35 departments, sixteen exclusively implanted TVTs, fifteen only used TOTs and four used both slings.

TVTs were more frequently in use at high volume departments as compared with the other departments and more often implanted by high volume surgeons in comparison to low volume surgeons (Tables 1, 2).Women treated by a medium (adjusted OR 1.82; 95%, CI 1.01-3.28, “frequency”) or high volume surgeon (1.98; 1.18-3.32, “frequency”) had an increased probability of cure compared to women treated by a low volume surgeon. However, this difference was only significant for women who received a TOT. Predictors for lowered cure were the most severe form of UI, a high BMI, mixed UI and a usage of antimuscarinic drugs.

Conclusion: This national population-based cohort study confirmed a high cure rate of synthetic MUSs at short-term follow. It is to the best of our knowledge the largest study to indicate a learning curve for TOT. The patient was not actively involved in which synthetic MUS to perform as the choice of surgical option was rather made at the departmental level.

Figure 1 Frequency, before and after treatment evaluated on the The International Consultation on Incontinence Questionnaire Short Form

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Table 1 Department volume and synthetic midurethral slings, 2007-2011, Denmark

Department volume High Volume departments Other departments P- value1
TVT 1485 (74.59) 844 (33.38) < 0.001
TOT 506 (25.41) 1684 (66.61)  
Total 1991 (100) 2528 (100)  

1Chi squared test

Table 2 Surgeon volume and synthetic midurethral slings, 2007-2011, Denmark

Surgeon volume1 Low Medium High P-value2
TVT 168 (34.78) 346 (37.04) 1699 (58.20) <0.001
TOT 315 (65.21) 588 (63.06) 1220 (41.80)  
Total 438 (100) 934 (100) 2919 (100)  

1Number of procedures during career as a surgeon, Low (≤25), Medium (26-75) and High (>75).

2 Chi squared test

Disclosure:

Work supported by industry: no.

153

Uroflowmetry parameters in healthy South African females

Abdool, Z 1 ; Manana, N 1 ; Swart, P 1 ; Becker, P 1 ; Van Wijk, F 1

1: University of Pretoria

Introduction: The pathophysiology of female lower urinary tract (LUT) dysfunction is still poorly understood (1). It is a common condition among females with a significant negative impact on various quality of life domains (2). Uroflowmetry is regarded as the first-line screening test in females with suspected LUT dysfunction. It is an important and simple investigative tool and currently there is a lack of standardized population specific nomograms.

Objective: This prospective study was performed to determine reference values for various uroflow parameters in a healthy South African female population. Secondly, to determine ethnic variation in measured parameters.

Methods: Healthy female volunteers, aged of 18-60 years were recruited during September to November 2017. Hospital staff, including nursing students and females from the general gynecology clinic were invited to participate. The study protocol was approved by the institutional ethics committee and informed consent was taken from each participant before enrollment in the study. The exclusion criteria included women who reported to be having lower urinary tract symptoms, previous pelvic surgery or radiation, neurological disease, diagnosed with a pelvic mass, pelvic organ prolapse, HIV and pregnancy. Participants were asked to report with a comfortably full bladder to the Urogynaecological department where the uroflowmetry was performed in a private room. The study was performed in accordance with the International Continence Society Good Urodynamic Practice recommendations (3). Data of voided volumes less than 50ml were not included in the data analysis. The average flow rates (Qave),maximum flow rate (Qmax), voided volume (VV), time to peak flow (TQmax), and voiding time (TVV) were recorded and analyzed. Quantile regression statistics was used to determine centile curves.

Results: Out of 216 volunteers, 169 participants were eligible for analyses. The mean age was 35.3 years (range, 20-60), mean parity 1.1 (range, 0-5). 72 (42.6%) females were nulliparous. Their mean average flow rate was (Qave) 10.20 ± 4.70mL/sec, peak flow rate (Qmax) 20.33 ±8.66mL/sec , voided volume 157.33 ± 99.53mL, time to maximum flow 5.40 ±3.94 sec and voiding time 21.95 ±14.04 sec. Age and parity were controlled for in the analysis of covariates. Nomograms for peak flow and average flow rates are demonstrated in figure 1. Black females (n=138) had statistically significantly higher average (p= 0.025) and maximum flow rates (p=0.038) than Caucasian females (n=31).

figurebo

Figure 1: Nomogram for average flow and peak flow rates in women aged 18-60 years.

Conclusion: These population specific nomograms can potentially allow clinicians to effectively screen women with voiding dysfunction. There are significant ethnic variations in urinary flow parameters which require further scientific validation.

References:

1.Obstet Gynecol Clin 1998; 25: 747-756

2. BJU International 2008; 101:1388-1395

3. Neurourol Urodyn 2017; 36:1243-1260

Disclosure:

Work supported by industry: no.

154

Long term compliance with repeated Botulinum toxin A injections in patients with neurogenic detrusor overactivity after spinal cord injury

Hebert, K 1 ; Klarskov, N 2 ; Bagi, P 1 ; Biering-Sørensen, F 3 ; Elmelund, M 4

1: Department of Urology, Rigshospitalet, University of Copenhagen, Denmark; 2: Department of Obstetricts and Gynecology, Herlev and Gentofte Hospital, University of Copenhagen, Denmark; 3: Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Denmark; 4: Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Denmark and Department of Obstetricts and Gynecology, Herlev and Gentofte Hospital, University of Copenhagen, Denmark

Introduction: Patients with spinal cord injury (SCI) have an increased risk of developing long-term urinary tract complications due to neurogenic detrusor overactivity (NDO).

Since 2001 we have offered Botulinum toxin A (Btx-A) injections as second line treatment for NDO patients. However little is known about patients compliance to repeated treatment with Btx-A

Objective: To examine patient compliance to treatment of NDO with repeated vesical Btx-A injections, and to investigate factors associated with discontinuation of the treatment.

Methods: This retrospective study included 128 patients with a SCI and urodynamically confirmed NDO. Patients were offered repeated Btx-A injections at in the period 2001−2016.

Patients were divided into two groups according to the interval between their last Btx-A injection and the follow-up date of this study: ≤2 years was categorized as “continuation group” and >2 years was categorized as “discontinuation group”.

Continuation rates of Btx-A injections were estimated using a Kaplan Meier analysis according to number of treatments. A Cox proportional hazard analysis was used to investigate factors associated with discontinuation.

The urodynamic effects of the primary Btx-A injection were investigated in patients with a pre- and post-treatment urodynamic investigation.

Results: This study included a total of 891 Btx-A treatments. The median number of treatments was 5 (range 1−47), the median time between treatments was 203 days and the median follow-up time was 8.9 years (range 0−14.9). The urodynamic parameters (max detrusor pressure during filling, cystometric capacity and reflex volume) changed significantly after the primary Btx-A treatment (p<0.001) in both groups. The probability of having at least five treatments with Btx-A was 68.8% (95% CI 59.5-76.1) and 53.4% (95% CI 43.3-62.5) had at least 10 treatments, with a stabilization of the continuation rate after 8 treatments (figure). No association was found between treatment discontinuation and gender, level and completeness of injury, age and etiology of injury (myelomeningocele vs. other etiologies to SCI).

Conclusions: This long-term follow-up study showed that half of the SCI patients starting vesical Btx-A treatment for NDO are still receiving injections after 10 treatments and the risk of discontinuation decrease dramatically after 8 treatments, suggesting a good long-term effect of repeated Btx-A injections.

Figure. Kaplan Meier curve showing the probability of continuation of treatment according to the amount of treatments (n=128)

figurebp

Disclosure:

Work supported by industry: no.

156

Should we always use antibiotics after urodynamic studies in high-risk patients?

Miotla, P 1 ; Wawrysiuk, S 1 ; Naber, K 2 ; Markut-Miotla, E 3 ; Skorupski, P 1 ; Skorupska, K 1 ; Rechberger, T 1

1: Medical University of Lublin, 2nd Department of Gynaecology, Lublin, Poland; 2: Technical University of Munich, Munich, Germany; 3: Medical University of Lublin, Department of Paediatric Pulmonology and Rheumatology, Lublin, Poland

Introduction: Urodynamic studies (UDS) are especially used to evaluate lower urinary tract function in patients with bladder outlet obstruction, urinary incontinence and neurogenic bladder dysfunction. UDS is an invasive procedure that involves catheterization. Urinary tract infection (UTI) or bacteriuria may be observed after UDS - with an incidence of bacteriuria ranging from 1.5 to 30%. It has been suggested in previous studies to only give antibiotic prophylaxis (AP) after UDS to high-risk patients. Indeed, the use of prophylactic antibiotics is still controversial due to their many adverse effects and an increase of resistance of bacterial uropathogens. Thus, it is important to find a balance between the symptoms and risk associated with UTI and costs, adverse effects and growing resistance to antibiotics.

Objective: The aim of this study was to evaluate the effectiveness of a phytotherapic drug (composed of centaury herb, lovage roots and rosemary leaves) in preventing UTI in high-risk women undergoing UDS.

Methods: The study protocol was approved by the local institutional ethical committee. Women with at least one risk factor for acquiring UTI (defined as: age over 70, elevated post-void residual urine>100 ml, recurrent UTI, pelvic organ prolapse (POP) ≥II in POP-Q scale, neurogenic bladder) had received after UDS either a single oral dose of fosfomycin trometamol (FT) (3 grams) or a phytodrug containing centaury herb, lovage root and rosemary leaves (5 ml taken orally three times daily for one week). All patients included into the study had negative urine dipstick tests for UTI before UDS. Urine samples were also tested with dipstick 7 days after UDS.

Results: Baseline demographic characteristics were similar between both groups (Table 1).

Table 1. Demographic characteristics of patients’ groups.

Variable Prophylaxis with fosfomycin trometamol (n=35) Prophylaxis with phytodrug (n=37) p
Age (years) 62.7 ±11.2 63.8 ±10.8 NS
BMI (kg/m2) 30.1 ±3.8 30.2 ±4 NS
Parity 2.1 ±1.12 2.3 ±0.97 NS
Menopause 28 (80%) 31 (83.7%) NS

Continuous variables are presented as the mean±SD, categorical variables are presented as number and %. Seven days after urodynamic studies UTI symptoms and positive urine dipstick tests occurred in two patients (one (2.8%) in the FT and one (2.7%) in the phytodrug group, respectively). No statistical differences in UTI incidence were found between both treatment groups. We did not observe any additional adverse events in both groups. The major disadvantage of prophylaxis with the phytodrug as compared to FT was the necessity of continuing therapy for 7 days.

Conclusions: Prophylaxis of UTI with a phytodrug may be considered as a good alternative to antibiotic prophylaxis used after UDS in high-risk patients.

Disclosure:

Work supported by industry: no. A consultant, employee (part time or full time) or shareholder is among the authors (Astellas).

157

Intraoperative variations of the retropubic TVT-procedure and their immediate and mid-term effects on patients’ outcome. A randomized controlled multicenter trial

Marschke, J1; Reisenauer, C2; Mikkola, T3; Schwab, F4; Tunn, R1; Huebner, M5

1: Department of Urogynaecology, German Pelvic Floor Centre, St. Hedwig Hospital, Berlin, Germany; 2: Department of Womenʼs Health, University Hospital of Tuebingen, Germany; 3: Department of Obstetrics and Gynecology, University Hospital of Helsinki, Finland; 4: Department of Hygiene and Environmental Medicine, Charité, Universitätsmedizin Berlin, Germany; 5: Women´s Center Bern, Lindenhofgruppe, Bern, Switzerland

Introduction: The retropubic TVT-procedure is a well-established surgical treatment for women suffering stress urinary incontinence (SUI) with excellent and reproducible long term-results (Nilsson CG, 2013). However, the effects of intraoperative variations of the methodology and characteristics of the material have not been studied extensively.

Objective: It was the aim of this study to analyze two different surgical techniques as well as two polypropylene tapes, which are manufactured differently, regarding postoperative cure rates and perioperative complications.

Methods: This is a prospective randomized controlled non-inferiority multicenter trial. Between 03/2014 and 01/2016 all patients scheduled for surgical therapy of stress urinary incontinence were included. Randomization was computer-generated. Patients were randomized into two groups: The TVT®-group was operated with an empty bladder, a 18 CH catheter was used with a straight inserter as instructed. Patients randomized into the RetroArc®-group were operated without inserter leading to a reduced catheter size (14 CH), bladder was filled (200 ml) during the procedure. Follow-up visits were at three months and one year after surgery. Primary endpoint was defined by objective cough test standing with filled bladder (200 ml) and supine empty stress test (SEST) as well as subjective parameters (questionnaires UDI-6 and ICIQ-UI-SF). Cure rate was defined by negative SEST and standing cough test as well as subjective parameters. Secondary endpoints were intra- and perioperative outcomes such as mean operative time and blood loss. In addition, ultrasound criteria such as the tape´s morphology and urethral distance were assessed with introital ultrasound and used to correlate these parameters with patients` outcomes. Patients and those assessing outcomes were blinded. Differences and its significances were tested using Fisher`s exact test, Chi-Square-test, or Wilcoxon ranksum-test (depending on distribution of parameters). This trial was approved by the local ethical committee and registered at clinicaltrials.org.

Results: N=303 women were recruited totally. Out of those, n=152 were randomized in the TVT®-Group, n=151 in the RetroArc®-Group. Primary endpoints are shown in Table 1. Mean operating time was in median 20 min (interquartile range (IQR): 10-36) in the TVT®-Group and 20 min (IQR 10-40) in the RetroArc®-Group (p=0.328). Mean blood loss was < 50ml in 98% (n=144/148 TVT®) vs. 100% (n=151 RetroArc®, p=0.083). Only four subjects in the TVT®-Group had a blood loss between 50-200ml, there was no blood loss >200 ml in either group. There were n=3 patients requiring surgical intervention for retropubic hematoma (n=1 TVT®, n=2 RetroArc®, p=0.554), n=1 Patient had bladder perforation detected and corrected during procedure (RetroArc®-group), p=0.315. In n=7 patients in the RetroArc®-group surgeons described difficulties in application (0 in TVT®-group, p=0.007).

Conclusions: Both methods result in excellent 12-month cure rates. Nonetheless we found differences of clinical relevance. The difference in tape texture might influence surgical procedure as well as differences we found in outcome and in sonomorphological description. The widely used operation standard has never been evaluated; the variations tested suggest positioning the tape whilst bladder is filled is also a viable option.

Parameter 3 months follow-up (N max =288) 12 months follow-up (N max =229)
TVT® (N max =144) RetroArc® (N max =144) p-Value* TVT® (N max =113) RetroArc® (N max =116 ) p-Value*
Supine empty stress test positive, % (n/N) 2.8 (4/144) 4.2 (6/143) 0.513b 0 (0/102) 3.8 (4/104) 0.126b
Cough Test positive, % (n/N) 6.9 (10/144) 13.9 (20/144) 0.054 8.0 (9/112) 14.2 (16/113) 0.144
Cure rate, % (n/N) 93.1 (134/144) 86.1 (124/144) 0.054 92.0 (103/112) 85.8 (97/113) 0.144
ICIQ-UI-SF total, median (IQR) 0 (0-4) 2.5 (0-7) 0.004a 0 (0-5) 4 (0-8) 0.004*a
ICIQ-UI-SF: Leaks when you cough or sneeze, % (n/N) 4.9 (7/144) 16.0 (23/144) 0.002 10.6 (12/113) 26.7 (31/116) 0.002*
UDI-6: Leakage related to physical activity >=2, % (n/N) 13.2 (19/144) 30.6 (44/144) <0.001 23.9 (27/113) 45.7 (53/116) 0.001*
Likert scale <=1, %
(„much better“) (n/N)
88.6 (117/132) 81.8 (108/132) 0.117 88.5 (100/113) 79.3 (92/116) 0.059
Ultrasound – sling rolled up (C-shaped),
% (n/N)
2.8 (4/144) 11.8 (17/144) 0.003 3.6 (4/112) 13.4 (15/112) 0.008*
Distance Tape Urethra (mm), median
(IQR)
6.3 (5.2-7.2) 6 (5-7) 0.015a 5.7 (5-7) 5.95 (5-7) 0.863a

Table 1: Summary of results *p-value, chi-square test if no other indicated; a Wilcoxon-ranksum test; b Fisher´s exact test; IQR, interquartile range: (25%percentile-75%percentile)

Disclosure:

Work supported by industry: yes, by AMS/Astellas.

158

BMI> 35 could be associated to a worse composite outcome for SUI sling procedure: retrospective study of a large dataset of patients from a prospective collected database

Pizarro-Berdichevsky, J1; Blümel, B2; Raby, T2

1: Urogynecology Unit H. Sotero del Rio - Division Obstetricia y Ginecologia Pontificia universidad Catolica de Chile; 2: Urogynecology Unit H. Sotero del Rio

Introduction: Few studies have evaluated surgical outcomes of stress urinary incontinence (SUI) in obese women. Most of them, have not demonstrated a difference in the short-term (<1 year) by BMI. However, there is a paucity in the literature in regards to long-term results.

Objectives: The aim of this study was to evaluate impact of BMI on retropubic slings (TVT) or transobturator slings (TOT) surgical failure and complications on the long-term follow-up (FU).

Methods: retrospective analysis was performed from our prospective collected pelvic floor database on patients who underwent TVT or TOT between 2008 – 2016 with BMI available on the database. Descriptive demographic data, surgery details, surgical failure according composite outcome (subjective complaint of SUI or leakage during exam or reoperation for SUI on FU), and complications (intraoperative bladder/urethral perforation, hematoma, suprapubic, groin or vaginal pain, mesh extrusion, reoperation for mesh complication, recurrent urinary tract infection, denovo urgency, voiding dysfunction). BMI was analyzed as continuous variable or stratified as normal weight (BMI < 25), overweight (BMI 25-30) or obese (BMI > 30) or as a dichotomous variable between normal vs overweight/obese or normal/overweight vs obese or as > or less than 31 or 32 or 33 or 34 or 35 (we could not analyzed above BMI of 36 due to low sample size). Data is presented as mean +/- SD, median (IQR) or n (%) as appropriate. A logistic regression analysis was used for the composite outcome including BMI, type of sling and all variables with p values < 0.1 on the univariate analysis.

Results: Between 2008-2016 881 patients underwent TOT or TVT, from those 706 patients meet the inclusion criteria. Of these, 419 (59.3%) were TVT and 287 (40.7%) TOT. Seventy-one patients (10.1%) were normal weight (≤25 kg/m2), 302 (42.8%) were overweight (25.1-30 kg/m2) and 333 (47.2%) were obese (≥30 kg/m2). The median FU was 32.7 months (4.6-50). Surgical failure according to composite outcome for these three groups were 7%, 9.9% and 9.9%, respectively (p=0.732). There were no differences using BMI as continues variable or among all the groups for composite outcome or other significant outcomes. However, when dividing the patients into two groups, BMI <35 kg/m2 and BMI ≥35 kg/m2, the composite outcome showed a significantly difference of 8.6% and 16.3%, respectively (p =0.025). After a logistic regression analysis the following variables persisted significant risk factors for the composite outcome: BMI ≥35 kg/m2 OR 2.2 (CI 95% 1.2- 4.1) and undergoing a TOT vs a TVT OR 1.7 (CI 95% 1.03- 2.8). Neither intraoperative nor postoperative complications showed significant differences between overweight and normal weight and obese and normal weight patients.

Conclusions: Women with BMI ≥35 kg/m2 and the transobturator approach had a 2.2 and 1.7 fold increased risk for surgical failure, respectively. Obese and overweight patients were equally likely to have complications from TVT/TOT. We concluded that TVT and TOT operations maybe equally safe for female SUI regardless of BMI, with the later one probably offering as slightly lower cure rate.

Disclosure:

Work supported by industry: no.

159

A randomised, controlled, double blind, clinical study in comparison of external NMES devices in patients with stress urinary incontinence: Effects on symptoms and quality of life

Soeder, S 1 ; Götze, M 2 ; Fink, T 3 ; Neymeyer, J 4 ; Tunn, R 5

1: Physiotherapy Department German Pelvic Floor Center St. Hedwig Hospital; 2: Kontinenzzentrum Brandenburg; 3: Urogynäkologie Sana Klinikum Lichtenberg; 4: Urogynäkologie Charite Berlin Campus Benjamin Franklin; 5: CA Urogynäkologie German Pelvic Floor Center St. Hedwig Hospital

Introduction: While results from several studies report that NMES (Neuromuscular Electrical Stimulation) can be effective in treating SUI (stress urinary incontinence), the issues of treatment technique, comfort and compliance often limit patient outcomes.1–3 This has led to the development of a novel, NMES device that includes a wired garment that uses external skin contact electrodes placed around the pelvic area to deliver electrical stimulation to pelvic floor muscles.

Objective: To assess whether a 12-week treatment programme with an NMES device significantly improved the symptoms of SUI in female subjects compared with a modified NMES device.

Methods: 50 female UK subjects with SUI were randomised into two groups. Subjects in the control group (n=26) received treatment with a modified NMES device, while subjects in the active group (n=24) used an active NMES device. The devices looked identical, but the modified device was programmed to produce a lower dose of pelvic floor muscle stimulation with a strong sensory response compared with the active device. Treatment comprised of a 30-minute session of NMES, in a standing position, 5 days per week, for 12 weeks. All subjects had previously failed a 6-week volitional pelvic floor muscle training programme or an equivalent lifestyle and exercise programme. Evaluations were completed at baseline and at screening, at study enrolment, and at 4, 8 and 12 weeks, and at 6, 9 and 12 months follow-up. Primary endpoints included reduction from baseline to 12 weeks in urine leakage with a one-hour pad weight test, and improvement from baseline to 12 weeks in the Incontinence Quality of Life Questionnaire (iQOL) Score. Secondary endpoints included the QoL Kings Health Questionnaire Score; incontinence episodes/day, voids/day, pads used/day; pelvic floor strength and quality of contraction scores; ease of use questionnaire, adverse events, and 24-hour pad weight test. Analyses were carried out using an Intention to Treat population and a Per Protocol population.

Results: At week 12, the difference in change between treatment arms was non-significant for the primary and secondary endpoints, apart from the 24-hour pad weight results, which showed statistically significant results at weeks 8 and 12 for the control group and active treatment group. (P=0.027 and P=0.044 respectively) (Figure 1). At week 12, there was also a numerical trend for greater improvements in the active group over the control group in iQOL Score (Figure 2) and the Kings Health Questionnaire Score. For the Modified Oxford Score (standing position), 40% of subjects in the control group and 47.6% in the active group had either good or moderate contraction in pelvic musc