International Urogynecology Journal

, Volume 23, Issue 7, pp 873–877

Impact on quality of life after ring pessary use for pelvic organ prolapse

Authors

    • Urogynecology Division, Department of Obstetrics and Gynecology, Faculty of MedicineChulalongkorn University
  • Suvit Bunyavejchevin
    • Urogynecology Division, Department of Obstetrics and Gynecology, Faculty of MedicineChulalongkorn University
Original Article

DOI: 10.1007/s00192-011-1634-6

Cite this article as:
Manchana, T. & Bunyavejchevin, S. Int Urogynecol J (2012) 23: 873. doi:10.1007/s00192-011-1634-6

Abstract

Introduction and hypothesis

The purpose of this study was to evaluate symptoms associated with pelvic organ prolapse (POP) and quality of life (QOL) improvement in patients who continue ring pessary use at 1 year.

Methods

Seventy-seven symptomatic POP patients had successful fitting, and 64 patients (83.1%) continued use at 1 year. The Thai version of Prolapse Quality of Life (P-QOL) questionnaire was used to evaluate symptoms associated with POP and impact on QOL. A higher score represents a greater impairment on the QOL, whereas a lower score represents a better QOL.

Results

Mean age was 66.7 ± 8.6 years, median parity was 4 (range 0–10), 59 patients (92.2%) were menopausal, and none had received hormone treatment. Only nine patients (14.1%) were sexually active. Most patients were in the advanced stage of POP—32.8% stage 3 and 29.7% stage 4. Improvement of prolapse symptoms and voiding difficulty were reported in 100% and 85.7% of the patients, respectively. Among patients who had lower urinary tract symptoms at pre-treatment, about half of patients improvement in frequency, urgency, and urgency urinary incontinence. Only 9.1% of the patients had improvement in stress urinary incontinence (SUI), and 23.8% of the patients reported new onset of SUI (de novo SUI). The median score from all P-QOL domains except personal relationships were significantly decreased after 1 year of ring pessary use. The median total scores at baseline and at 1 year were 40 and 8, respectively (P < 0.001).

Conclusions

Ring pessary is an effective non-surgical treatment to alleviate symptoms associated with POP. It can improve QOL in symptomatic POP patients.

Keywords

Pelvic organ prolapsePessaryQuality of life questionnaire

Introduction

Vaginal pessary is a conservative treatment for pelvic organ prolapse (POP) and can be offered as the first-line treatment. A survey of the American Urogynecologic Society showed that 98% of members use pessaries in their practice, and 77% offered pessaries as a first-line treatment [1]. Among various vaginal pessaries, ring pessary is the most common type. It is easiest to insert and remove. Our previous study reported that ring pessary can be attempted in all POP patients irrespective of stages of prolapse. It has an acceptable continuation rate and manageable adverse events [2].

Anatomical restoration by objective measures is important, but subjective measures of symptomatic relief and improvement in quality of life (QOL) is essential in treating POP. These are the most important outcomes in urogynecologic studies in a survey of physicians, nurses, and patients [3]. Most studies about pessary use usually focused on successful fitting, continuation rate, and adverse events. Few studies have focused on symptomatic relief and evaluated the impact of a symptom on patient’s activities and well-being by using psychometrically self-administered questionnaires. QOL can be used as a surrogate outcome of patient satisfaction and success following treatment. Various QOL questionnaires have been developed including the Prolapse Quality of Life (P-QOL) questionnaire [4]. It is simple, valid, and reliable with validated translation in many languages including Thai [5]. The aim of this study was to evaluate symptoms associated with POP and QOL improvement in patients who continue ring pessary use at 1 year.

Materials and methods

Patients with symptomatic POP who came to the gynecologic outpatient clinic between May 2007 and April 2010 were counseled for their treatment options either surgery or vaginal pessary. One hundred twenty-six patients agreed to trial a vaginal pessary. A ring pessary (Chinda Dispensary Registered Ordinary Partnership, Bangkok, Thailand) was used. The detail of this pessary was described in our previous study [2]. Retrospective observational study was conducted that was approved by the Institutional Review Board of the Faculty of Medicine, Chulalongkorn University. Baseline characteristics such as age, parity, menopausal status, body mass index (BMI), and sexual activity status were recorded. POP was staged according to the Pelvic Organ Prolapse Quantification (POPQ) system [6]. The Thai version of P-QOL questionnaires were completed by the patients before and at 1 year after ring pessary use.

The P-QOL questionnaire includes 20 questions in nine domains: general health perceptions, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotional problem, sleep or energy disturbance, and measurement of symptom severity. Another 18 questions regarding the prolapse symptom, bladder, bowel, and sexual function are included. These are not used for score analysis but for recording the symptom changes associated with POP. A four-point grading system for each item is used except for the first question on the general health which has five points. The total score in each domain is transformed to a range between 0 and 100. A higher score represents a greater impairment on the QOL; a lower score, a better QOL [4].

Patients who were fitted at the initial visit were evaluated within 2 weeks. Successful fitting was defined as follows: (1) a patient who continued the pessary use for more than 2 weeks and (2) a patient who had pessary expulsion and was refitted with a new size of pessary at the second visit and continued use for more than 2 weeks. Patients who discontinued pessary within the first 2 weeks and were not able to be refitted were categorized as unsuccessful fitting [2]. Pessary care techniques were explained to the patients and caregivers. Topical estrogen was prescribed to all menopausal women at the interval of one to two times per week. They were advised to remove the pessary at least once weekly at nighttime on the same day that they applied the topical estrogen. Then, the pessary was cleaned with water and reinserted in the morning. The patients were assigned for routine follow-up every 6 to 12 months. If the patients experienced difficulty with pessary care, follow-up was made every 3 months. Only those who continued pessary use at 1 year completed the Thai version of P-QOL questionnaire. Those who were lost to the follow-up were defined as discontinuation.

Sample size calculation was based on previous data that 70–92% with a mean value of 81% of patients was satisfied after pessary use due to improvement of symptoms associated with prolapse [7, 8]. A sample size of 60 was calculated with 95% significant level and 10% maximum allowable error. Demographic data are shown as means, medians, and percentages. The chi-square or Fisher exact test was used to compare the categorical variable. The median values of continuous variables were compared by the Mann–Whitney U test. Comparison of symptoms associated with POP and P-QOL scores between pre-treatment and post-treatment were analyzed by McNemar chi-square and Wilcoxon signed rank test, respectively. A P value of less than 0.05 was considered statistically significant.

Results

One hundred twenty-six symptomatic POP patients agree to trial of pessary insertion. Thirty-eight patients (30.1%) were in POPQ stage II, 51 (40.5%) in stage III, and 37 (23.8%) in stage IV. However, 77 patients had a successful fitting. More than half of the patients were in advanced stage of POP: 27 (35.1%) stage 3 and 24 (31.2%) stage 4. Only 26 patients (33.8%) were in stage 2. All patient’s characteristics such as age, parity, menopausal status, POP stage, and preexisting lower urinary tract (LUT) symptoms were not significantly different between who had successful and unsuccessful fitting (Table 1).
Table 1

Patient’s characteristics between who had successful fitting and unsuccessful fitting

 

Successful fitting (n = 77)

Unsuccessful fitting (n = 49)

P value

Age (years)

66.9 ± 8.7

66.8 ± 9.0

0.85

Parity

4 (0–10)

4 (1–17)

0.41

Menopause

72 (93.5%)

45 (91.8%)

0.41

Sexually active

10 (13.0%)

2 (4.1%)

0.21

BMI (kg/m2)

24.6 ± 3.5

23.8 ± 2.8

0.54

POP stage 2

26 (33.8%)

12 (24.5%)

0.34

 3

27 (35.1%)

24 (50.0%)

 

 4

24 (31.1%)

13 (26.5%)

 

Advance stage

51 (66.2%)

37 (75.5%)

0.24

Previous hysterectomy

12 (15.6%)

11 (22.4%)

0.59

Medical diseases

51 (66.2%)

35 (71.4%)

0.56

Preexisting frequency

21 (27.3%)

21 (42.9%)

0.05

Preexisting urgency

38 (49.4%)

27 (55.1%)

0.35

Preexisting UUI

31 (40.3%)

25 (51.0%)

0.14

Preexisting SUI

30 (40.0%)

23 (46.9%)

0.26

Preexisting voiding difficulty

52 (67.5%)

27 (55.1%)

0.34

POP pelvic organ prolapse, UUI urgency urinary incontinence, SUI stress urinary incontinence

During 1 year of ring pessary use, eight patients were lost to follow-up. Five patients requested reconstructive surgery: three had vaginal hysterectomy and two colpocleisis. Therefore, 64 in 77 patients (83.1%) continued ring pessary use at 1 year and completed the P-QOL questionnaires (Fig. 1). Mean age was 66.7 ± 8.6 years, median parity was 4 (range 0–10), and mean BMI was 24.4 ± 3.6 kg/m2. Most patients were in the advanced stage of POP—32.8% stage 3 and 29.7% stage 4. Fifty-nine patients (92.2%) were menopausal, and none had received hormone treatment. Only nine patients (14.1%) were sexually active, and 39 patients (60.9%) had underlying medical diseases such as hypertension, dyslipidemia, diabetes mellitus, and heart disease. Ten patients had previous hysterectomy: nine abdominal and one vaginal. One patient had previous pelvic floor reconstruction (anterior and posterior colporrhaphy).
https://static-content.springer.com/image/art%3A10.1007%2Fs00192-011-1634-6/MediaObjects/192_2011_1634_Fig1_HTML.gif
Fig. 1

Patient flow chart

The changes of symptoms associated with POP are shown in Table 2. There were significantly decrease of these symptoms from pre-treatment to post-treatment: vaginal bulge or lump (100% to 0%; P < 0.001), frequency (28.1% to 10.9%: P = 0.001), and voiding difficulty such as poor urine stream or straining (65.6% to 9.4%; P < 0.001). Although urgency, urgency urinary incontinence (UUI), and constipation were decline after treatment, they did not reach statistically significant. In contrast, stress urinary incontinence (SUI) increased significantly at post-treatment (34.4% to 46.9%; P = 0.04). However, the severity of SUI at post-treatment was mild. No patient discontinued pessary use due to this reason.
Table 2

The changes of symptoms associated with pelvic organ prolapse

Symptoms

Pre-treatment

Post-treatmenta

P value

Vaginal bulge or lump

Yes

64 (100%)

Yes

0 (0%)

<0.001

No

0 (0%)

No

64 (100%)

Frequency of urination

Yes

18 (28.1%)

Yes

7 (10.9%)

0.001

No

46 (71.9%)

No

57 (89.1%)

Urgency

Yes

31 (48.4%)

Yes

21 (32.8%)

0.06

No

33 (51.6%)

No

43 (67.2%)

Urgency urinary incontinence

Yes

25 (39.1%)

Yes

18 (28.1%)

0.21

No

39 (60.9%)

No

46 (71.9%)

Stress urinary incontinence

Yes

22 (34.4%)

Yes

30 (46.9%)

0.04

No

42 (65.6%)

No

34 (53.1%)

Voiding difficulty

Yes

42 (65.6%)

Yes

6 (9.4%)

<0.001

No

22 (34.4%)

No

58 (90.6%)

Constipation

Yes

15 (23.4%)

Yes

10 (15.6%)

0.06

No

49 (76.6%)

No

54 (84.4%)

aYes persisting and new-onset symptoms, No no and ameliorated symptoms

Among patients who had LUT symptoms at pre-treatment, more than half of patients had improvement: frequency (12 of 18 patients—66.7%) and voiding difficulty (36 of 42 patients—85.7%). Urgency and UUI improved in almost half of patients 15 of 31 patients (48.4%) and 12 of 25 patients (48%), respectively. However, more than half of them had persisted urgency and UUI. Therefore, these symptoms at post-treatment which included persisted and new onset (de novo) of symptoms had no significant change (Table 2). Alternatively, only 9.1% (two of 22 patients) had improvement of SUI. Among patients who had no symptoms at pre-treatment, de novo frequency occurred in one of 46 patients (2.2%), de novo urgency in five of 33 (15.1%), de novo UUI in five of 39 (12.8%), and de novo SUI in ten of 42 (23.8%). No de novo voiding difficulty and constipation was reported.

The total and all domain scores were significantly decreased after 1 year of ring pessary use except for the personal relationships domain (Table 3). Personal relationships domain was evaluated whether prolapse affected the relationship with their partners, sex life, and family life. Sub-analysis was evaluated in nine patients (14.1%) who were sexually active. The median score in personal relationships domain at baseline was 33 (interquartile range = 0, 67) which was lower after 1 year use of ring pessary (0, interquartile range = 0, 24.8). However, there was no significant difference (P = 0.18).
Table 3

The total and the scores from all P-QOL domains compared between pre-treatment and post-treatment with ring pessary use

P-QOL domains

Pre-treatment

Post-treatment

P value

General health perceptions

50 (25, 50)

25 (25, 50)

0.005

Prolapse impact

67 (50, 100)

33 (0, 33)

<0.001

Role limitations

67 (33, 91.5)

0 (0, 0)

<0.001

Physical limitations

50 (25, 83)

0 (0, 0)

<0.001

Social limitations

33 (0, 44)

0 (0, 0)

0.001

Personal relationships

0 (0, 0)

0 (0, 0)

0.18

Emotions

56 (33, 67)

0 (0, 22)

<0.001

Sleep/energy

17 (0, 33)

0 (0, 17)

0.02

Severity measures

25 (8, 42)

0 (0, 17)

0.001

Total

40 (29.5, 53.5)

8 (3, 13)

<0.001

The values are shown as median and interquartile ranges in parentheses

P-QOL prolapse quality of life

Discussion

Vaginal pessaries are well tolerated and improve the symptoms associated with POP [714]. However, few studies used validated questionnaires [1114]. There is limited information on the evaluation of symptoms associated with POP and QOL with pessary using P-QOL questionnaires. These include questions regarding most symptoms associated with POP including a vaginal bulge, vaginal discomfort, urgency, UUI, SUI, voiding difficulty, and bowel dysfunction. In our study, prolapse symptoms and voiding difficulty improved or resolved at 1 year after ring pessary use in almost of all patients. More than half of the patients had improvement in most LUT symptoms except SUI. Only 9% of the patients with preexisting SUI had improvement or resolution. Clemons et al. reported about 45% of patients had improvement at 2 months, while Fernando et al. reported a 23% improvement at 4 months [7, 10]. Different evaluation times and types of pessary might be plausible explanation for the discrepancy. Only one type of pessary (ring pessary) was used in our study. A ring pessary with incontinence knob or other types of incontinence pessary was not included in this study. In contrast, up to 24% of the patients without SUI at baseline had new onset of SUI which was comparable to a previous study [7]. SUI can be masked by urethral compression or kinking from POP. Unsurprisingly, the symptom appears when the prolapse is restored to normal anatomical position. POP can cause bladder outlet obstruction which induces detrusor muscle contraction. Therefore, overactive bladder symptom resolves in up to 50% after surgical correction for POP [15]. This finding was comparable to our study which reported urgency and UUI improved in 48% of the patients. However, the topical estrogen which was prescribed to all menopausal patients might also influence the improvement.

Bowel dysfunction is another symptom associated with POP. The questions related to bowel dysfunction in the P-QOL questionnaire includes constipation, straining to defecation, and incomplete fecal emptying. Fecal incontinence is not included which is a limitation of P-QOL questionnaire. More specific questionnaires focused on fecal incontinence are needed. However, the improvement of bowel function after ring pessary use was reported in up to one third of patients, although there was no significant difference. Behavioral change counseling and laxative drugs were given, and these may be the causes of the improvement.

This study shows significant improvement of QOL after 1 year of ring pessary use for POP. Significantly lower scores in almost of all domains except the personal relationships domain were reported in symptomatic POP patients after 1 year use of ring pessary. POP has a negative impact on sexual function, and it is able to improve after pessary use [16]. However, the small number of sexually active patients in this study did not allow a detected analysis. Furthermore, specific questionnaires focusing sexual dysfunction should be used for evaluation.

Measuring the changes of symptom severity and QOL in women with pelvic floor disorder is an important part of the evaluation and treatment [17]. Strength of this study was using validated QOL questionnaire to assess the change of symptoms associated with POP and QOL improvement. However, the limitations of this study were a retrospective design, and the other types of pessaries were not included because they were not available in our institute before 2010. Slightly higher rate of successful fitting was reported from previous studies owing to higher use of the space-occupying pessary [7, 9, 10]. This might not affect the result, which aimed to evaluate the symptomatic and QOL improvement after pessary use. Furthermore, the positive effect of pessary on symptoms associated with POP and QOL should be proved in a longer follow-up time.

In conclusion, ring pessary is an effective non-surgical treatment to alleviate symptoms associated with POP. It can be attempted in all POP irrespective of stage with an acceptable continuation rate at 1 year. It can improve QOL in symptomatic POP patients which should be the most important surrogate outcome. Therefore, ring pessary should be considered to be the first choice of POP treatment, if that is the patient’s choice.

Conflicts of interest

None.

Copyright information

© The International Urogynecological Association 2012