International Urogynecology Journal

, Volume 20, Issue 3, pp 313–317

TVT-secur: a minimally invasive procedure for the treatment of primary stress urinary incontinence. One year data from a multi-centre prospective trial

Authors

    • Department Obstetrics and GynecologyOspedale “G. Fornaroli”
  • Pietro Barbacini
    • Department Obstetrics and GynecologyOspedale “G. Fornaroli”
  • Virginio Ambrogi
    • Department of Obstetrics and GynecologyOORR
  • Paola Pifarotti
    • Department of Obstetrics and GynecologyIRCCS Fondazione Policlinico Mangiagalli e Regina Elena
  • Luisa Ricci
    • Department Obstetrics and Gynecology
  • Lorenzo Spreafico
    • Department Obstetrics and Gynecology
Original Article

DOI: 10.1007/s00192-008-0772-y

Cite this article as:
Meschia, M., Barbacini, P., Ambrogi, V. et al. Int Urogynecol J (2009) 20: 313. doi:10.1007/s00192-008-0772-y

Abstract

The objective of this study is to evaluate the efficacy and morbidity of the new minimally invasive TVT-secur procedure. This was a prospective multi-centre trial. All patients with primary urodynamic stress urinary incontinence were prospectively selected to receive the TVT-secur procedure. The International Consultation on Incontinence—Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS), Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Improvement (PGI-I) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on quality of life (QoL) and to measure patient’s perception of incontinence severity and improvement. The SPSS software was used for data analysis. From November 2006 to September 2007, 95 consecutive patients were enrolled in the study. At 1 year, 91 patients were available for the analysis. The subjective and objective cure rates were 78% and 81%, respectively. The ICIQ-SF and W-IPSS symptoms score showed a statistically significant decrease. Post-operative complications included voiding difficulty, recurrent UTI, de novo urgency incontinence and dyspareunia. Our data show that TVT-secur is associated with an 80% success rate at 1 year.

Keywords

ComplicationsNew surgeryQoLStress urinary incontinenceTVT-secur

Abbreviations

SUI

stress urinary incontinence

QoL

quality of life

MUCP

maximum urethral closure pressure

Introduction

The TVT-secur system is a new, minimally invasive sling procedure for the treatment of female stress urinary incontinence (SUI). The device consist of a short 8 × 1.1-cm prolene laser cut tape, the same material of the standard TVT, which is coated on both ends with an absorbable fleece material (Ethisorb). The absorbable material is made of Vicryl and PDS (Polyglactin 910 and Poly-P-Dioxanon) and it has been shown to provide strong fixation force into tissues with pull-out force as high as the initial fixation force of standard TVT [1]. This material is usually absorbable within 90 days with prolene remaining intact to provide long-term fixation.

A curved stainless steel inserter instrument and “release wire” is attached on both ends to the mesh. The prosthetic implant is placed under the mid-urethra and can be fixed in the “hammock” position into the obturator internus muscle or in the “U”-shaped position into the connective tissue of the urogenital diaphragm behind the pubic bone (Fig. 1).
https://static-content.springer.com/image/art%3A10.1007%2Fs00192-008-0772-y/MediaObjects/192_2008_772_Fig1_HTML.gif
Fig. 1

The device can be placed both in a “hammock” or “U” position

The aim of the present study was to evaluate the efficacy and morbidity of the new minimally invasive TVT-secur procedure in the treatment of primary SUI.

Materials and methods

The study design was a prospective multi-centre trial involving four different hospitals. All patients with primary urodynamic SUI and urethral hypermobility were prospectively selected to receive the TVT-secur procedure. Each centre was allowed to perform the procedure either in the “hammock”- or “U”-shaped approach. Exclusion criteria from the study were: previous anti-incontinence surgery, pelvic organ prolapse requiring treatment, any coexistent pelvic pathology, urethral hypomobility (ΔQ-tip <20°) and detrusor overactivity. The pre- and post-operative protocol included the following: a detailed urogynaecologic history, a physical examination, a cotton swab test, a stress test in the supine and standing positions with a comfortably filled bladder (300 mL) and a multi-channel urodynamic evaluation. The International Consultation on Incontinence—Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS), Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Improvement (PGI-I) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on quality of life (QoL) and to measure patient’s perception of incontinence severity and improvement. These questionnaires have been validated in the Italian language [2, 3].

The ICIQ-SF comprises three scored items: assessment of frequency (0–5), severity (0–6) and perceived impact of incontinence (0–10) and an unscored self-diagnostic item. The W-IPSS was developed to evaluate irritative (three items) and obstructive (four items) bladder symptoms; for each item, the score ranges from 0 (never) to 5 (always). PGI-S and PGI-I are global indexes of severity and improvement that summarise the severity or improvement in single questions with four and seven response categories, respectively.

The post-operative evaluation included collection of data regarding intra- and post-operative complications and analysis of outcomes. The outcome of surgical treatment was estimated both subjectively and objectively using the same tools as before surgery and the PGI-I questionnaire was added to assess the subjective perception of improvement. Objective cure was defined as no leakage of urine whilst coughing during the post-operative stress test. Subjective cure was defined as no urine loss during exertion and failure as any reported leakage of urine during “stress”. Urodynamic techniques and measurements, terms and diagnostic criteria conform to the recommendations of the International Continence Society [4].

All patients were informed about the study and procedure and gave their informed consent. The Statistical Package for Social Sciences (SPSS 14.0) was used for data analysis. Continuous data were reported as the means±standard deviation (SD) and analysed with Student’s t test. Categoric relationship were analysed by the χ2 test with Yates’ correction or Fisher’s exact test, as appropriate. Probability values of <0.05 were considered statistically significant.

Results

From November 2006 to September 2007, 95 consecutive patients with primary urodynamic SUI and urethral hypermobility were enrolled in the study. The population’s demographic and clinical characteristics are shown in Table 1.
Table 1

Baseline characteristics of patients enrolled in the study

 

Patients N = 95

Age (years)

57 ± 10 (36–79)

Parity, median (range)

2 (0–6)

BMI (kg/h2)

27.1 ± 5

Menopausal, n (%)

60 (63)

Patients with OAB symptoms, n (%)

28 (29%)

Straining Q-tip angle (Δ°)

51 ± 16

ICIQ-SF

15 ± 3.8

PGI-S

2.4 ± 0.6

W-IPSS

7.7 ± 6.6

After enrolment, 55 patients received the procedure with insertion of the tape in the “hammock”-shaped position and 40 subjects in the “U”-shaped position. There were no differences between these two groups with respect to pre-operative demographic and clinical characteristics, total score in the different questionnaires used and urodynamic parameters. Data are shown in Table 2.
Table 2

Comparison between patients undergoing the “hammock”- and “U”-shaped approaches

 

“Hammock” N = 55

“U” N = 40

p value

Age (years)

57 ± 10

56 ± 10

0.63

Parity, median (range)

2 (0–4)

2 (0–6)

1

BMI (kg/h2)

27 ± 5.4

27 ± 4.5

1

Menopausal, n (%)

38 (69)

22 (55)

0.42

Patients with OAB symptoms, n (%)

16 (29)

12 (30)

0.89

Straining Q-tip angle (Δ°)

50 ± 15

53 ± 17

0.36

MUCP (cm H2O)

67 ± 25

69 ± 23

0.69

ICIQ-SF

15 ± 3.6

15 ± 4.3

1

PGI-S

2.4 ± 0.6

2.4 ± 0.6

1

W-IPSS

8.3 ± 7.6

7.1 ± 5.6

0.40

MPCU maximum urethral closure pressure

The procedures were performed either under general (68%) or local anaesthesia (32%) and cystoscopy was performed in all the patients who underwent the procedure in the “U”-shaped approach, whilst only 14 out of 55 patients (25%) in the “hammock”-shaped group underwent cystoscopy. The intra-operative cough stress test was performed in only six patients, no bladder perforation occurred. There was excessive bleeding, greater than 500 mL, in two patients both receiving the “hammock”-shaped approach, and some difficulties with the detachment of the device were reported in two subjects. These two patients were managed by removing the initial tape and with the insertion, during the same session, of a new one. Four women (4.2%) had voiding difficulty that resolved spontaneously within the first 5 days from surgery and no one had urinary retention. The average hospital stay was 1.4 ± 0.9 days and post-operative pain was reported by only one woman.

The mean follow-up time was 15 ± 3 months. Ninety-one patients were available for the analysis because four women were lost to follow-up as they referred to their private doctors. Subjectively, 71 (78%) women were cured by the procedure and, objectively, the cough stress test was negative in 74 (81%) patients. No difference in the success rate was seen between women who underwent the “hammock”-shaped approach (79%) and the “U”-shaped approach (77%).

The ICIQ-SF questionnaire symptoms score showed a highly statistical decrease from a mean of 15 ± 3.8 before surgery to a mean of 4.4 ± 5.7 at the last follow-up visit forwarded (p = 0.000), the W-IPSS decreased from 7.7 ± 6.6 to 5.1 ± 4.6 (p = 0.002). Most of the women were satisfied of their post-operative condition with a mean score of 0.8 ± 1.1 at the PGI-I questionnaire (scale 0–6). Post-operative complications included: voiding difficulty in seven women (8%), recurrent UTI in nine (10%), de novo urgency incontinence in nine (10%) and dyspareunia for a defect healing with vaginal protrusion of the mesh in two patients. Eight out of 20 failures underwent a new anti-incontinence procedure within the first year of follow-up: five of them received a retropubic TVT, two a transobturator sling and one a Reemex implant. Four women were treated with duloxetine and two patients underwent pelvic floor muscle training. Seven women with distressing overactive bladder (OAB) symptoms were given a trial with anti-muscarinic drugs. Table 3 summarises the outcomes and complications.
Table 3

Results and complications in 91 available women who underwent the TVT-secur procedure

Cure rates

 

Women without SUI symptoms, n (%)

71/91 (78)

Negative stress test, n (%)

74/91 (81)

ICIQ-SF (mean±SD)

4.4 ± 5.7*

W-IPSS (mean±SD)

5.1 ± 4.6**

PGI-I (mean±SD)

0.8 ± 1.1

Complications

 

Voiding difficulty, n (%)

7 (8)

Urinary tract infection, n (%)

9 (10)

“De novo” urgency incontinence, n (%)

9 (10)

Defect healing, n (%)

2 (2)

*p = 0.000 and ** p = 0.002 when compared with pre-operative data

Discussion

The TVT-secur system was first introduced in Europe in the late 2006. The device was developed with the aim to further reduce the invasiveness of the surgical procedures currently used for the treatment of SUI avoiding the passage of the needle carriers through the retropubic or obturator regions. It has been demonstrated that the blind passage of the needle in the retropubic space may carry an increased risk of vascular or visceral complications [5]. Nevertheless, the transobturator techniques have also been associated, even if less frequently, with some complications such as bladder perforations, vulvar haematoma, groin pain and abscess [5, 6]. The advantages of this new technique are thus related to the short way of the needles that minimise the risk of vascular, nerve or visceral injury.

Some concerns may arise regarding the strength at the fixation point and the tensioning manoeuvre required for being successful. In a sheep model, histology revealed good tissue integration of a TVT-secur prototype within 12 weeks after implantation and initial pull-out forces similar to those observed with the standard TVT with a significant increase of the pull-out values over time [1]. For tensioning, it has been recommended to place the tape close to the urethra with no space allowed in between and to apply a minimal extra tension to the tape because the tape is not elastic and pushed into the tissues rather than pulled through the tissues; therefore, it will not get tighter after insertion [7].

Some surgeons recommend to perform routinely an intra-operative cough test for the proper tension of the sling in order to achieve better results on post-operative continence rate, but conflicting data are available in supporting this hypothesis [811].

In our series, more than half of the patients underwent the procedure under general anaesthesia, and the cough test was performed in a very limited number of cases. There were two patients that experienced excessive bleeding whilst inserting the tape in the hammock shape. One of them was managed by vaginal packing and she recovered well, the other was initially treated similarly but persisting vaginal bleeding required a surgical revision: haemostatic stitches were placed in the lateral vaginal sulcus and the vagina filled with haemostatic gauzes. The haemoglobin concentration fell from 13.3 to 7.8 g/dL the day after surgery but no blood transfusion was given. Further post-operative course was without complications and the patient was discharged on the fifth post-operative day.

A severe haemorrhagic complication has been recently described [12] that required a surgical revision of the Retzius space to remove 1 L of blood clots. The site of the bleeding was found to be on the obturator muscle, apparently from the incision made by the tape inserter. Despite the fact that the place of insertion in the obturator muscle is relatively safe and avascular, the scalpel-shaped tip of the inserter could tear the muscle fibres, leading to excessive bleeding that can be difficult to control.

Our data show that the TVT-secur procedure is effective for the treatment of primary SUI with 78% and 81% subjective and objective cure rates, respectively. No differences were seen in success rates when the tape was inserted in the “hammock”- or “U”-shaped position and although the patients were not randomised to each procedure, the two groups were similar in terms of age, body mass index (BMI), maximum urethral closure pressure (MUCP), presence of OAB symptoms, ΔQ-tip angle at strain, incontinence severity and bother of condition. Nevertheless, whilst performing the procedure in the “hammock”-shaped approach, there is no use for cystoscopy as complication and success rates were not affected.

The ICIQ-SF and W-IPSS questionnaires showed a significant score decrease after surgery, suggesting an improvement in QoL being most patients satisfied of their post-operative condition as shown by the PGI-I questionnaire. However, we must underline that a comparison with our own previously published data on TVT and TVT-O showed that TVT-secur is associated, at the same follow-up time, with a 10% lower success rate [13].

One can argue that our less satisfying results with the TVT-secur system might be due to the initial learning curve, but each surgeon was requested to perform at least ten procedures before starting the enrolment. Again, to avoid the risk of underestimating the effectiveness of the procedure, we performed a sub-analysis where the first ten cases for each centre were removed. Analysing the remaining 51 patients, figures were similar to those of the whole sample with 40 (78%) and 42 (82%) patients being subjectively and objectively cured. Table 4 shows the results for the first 40 patients, ten for each centre, enrolled in the study.
Table 4

Results and complications for the first ten cases for each centre

Cure rates

 

Women without SUI symptoms, n (%)

31/40 (77.5)

Negative stress test, n (%)

32/40 (80)

ICIQ-SF (mean±SD)

4.5 ± 6.2*

W-IPSS (mean±SD)

4.3 ± 3.7**

PGI-I (mean±SD)

0.75 ± 1.05

Complications

 

Voiding difficulty, n (%)

2 (5)

Urinary tract infection, n (%)

3 (7.5)

“De novo” urgency incontinence, n (%)

3 (7.5)

Defect healing, n (%)

1 (2.5)

*p = 0.000 and ** p = 0.002 when compared with pre-operative data

Conclusions

The TVT-secur procedure seems to be an effective treatment for women with primary SUI with an overall success rate of 80%. No differences were seen in success rates between the two different ways to perform the procedure, but the hammock approach has the advantage that cystoscopy is not routinely required. Intra-operative complications are undoubtedly rare, but excessive bleedings have been reported and their management can be difficult even for skilled surgeons. Comparing the present results with our own previously published data on TVT and TVT-O, we must emphasise that a 10% drop in success rate has been observed; therefore, we believe that TVT or TVT-O remain the reference surgical approaches as far as data from on-going randomised studies with large numbers of patients will be available.

Conflicts of interest

None.

Copyright information

© The International Urogynecological Association 2008