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Clinical Trials/NCT06521450
NCT06521450Not yet recruitingNot Applicable

Concurrent Surgery for Prolapse Repair and Stress Urinary Incontinence to Reduce the Risk of Postoperative Surgical Intervention for Incontinence

Shalamar Institute of Health Sciences0 sites130 target enrollmentStarted: October 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
130
Primary Endpoint
symptomatic stress urinary incontinence requiring surgery at six months

Study Overview

Brief Summary

Urinary incontinence is a common and distressing medical condition which affects 26% of women in developing countries.Globally upto 54% women suffer from pelvic organ prolapse and stress urinary incontinence concomitantly.Women with coexisting stress incontinence have a 40% risk of undergoing subsequent surgery for postoperative stress incontinence and woem with occult incontinence have a 15% risk.Overall,there is sufficient evidence that for women who are symptomatic of stress incontinence and prolapse,concomitant vaginal surgery for both problems is beneficial for reducing postoperative incontinence.However,it must be borne in mind that in woen undergoing vaginal prolapse surgery alone,almost 1/3 may experience cure of incontinence symptoms and despite concomitant continence surgery,stress urinary incontinence persist in approximately 1/3 of women.This study will be conducted to assess whether women with polpase and stress urinary incontinence could benefit from combined surgery in regards of requiring further surgery for stress incontinence.

Detailed Description

INTRODUCTION

Urinary incontinence (UI), is a common and distressing medical condition which affects 26% of women in developing countries and stress urinary incontinence (SUI) (12.6%) is the most common type.1 One of the important risk factors for SUI is pelvic organ prolapse.2 Pelvic organ prolapse(POP) is descent of pelvic organs resulting in protrusion of pelvic structures including bladder, rectum and uterus beyond their anatomical confines. In low and middle-income countries, the prevalence of pelvic organ prolapse is 19.7% (estimated range is 3.4%-56.4%).3 In a study, the prevalence of prolapse in Pakistan was 10.3%.4 Globally in up to 54 % of women, pelvic organ prolapse and stress incontinence coexists.5 In Pakistan 12.5% women will suffer with both prolapse and urinary incontinence.2

Patients showing no improvement with conservative measures are offered surgery. The surgical methods used for SUI include Burch colposuspension (BC), tension-free vaginal tape (TVT)and trans obturator tape (TOT).6 For prolapse the route of repair can be abdominal or vaginal and surgical methods include reconstructive procedures preserving uterus or vaginal hysterectomy.7 The uterus preserving surgeries include Sacrohysteropexy (ASC), sacrospinous ligament fixation, ventrosuspension and Manchester repair.8,9

Many women undergoing surgery for pelvic organ prolapse (POP) will experience incontinence after prolapse repair. Developing incontinence after prolapse repair is even more common among women with urinary incontinence before the surgery.10 In a recent study women with coexisting SUI have a 40% risk of undergoing subsequent surgery for postoperative SUI and women with occult SUI have a 15% risk. 10 It is shown in some studies that women could have lower risk of subsequent continence surgery for SUI after combination surgery than after prolapse surgery only.11 However, another study showed that about a third of women with POP and SUI will experience resolution of SUI symptoms following isolated POP repair.12,13 Van der Ploeg et al. conducted a large multicentre RCT, and results showed a significant reduction in postoperative SUI rates in the combined surgery group as compared to POP repair only; 22% versus 61% .Despite 61% of women reporting postoperative SUI in the POP repair-only group, only 17% went on to receive surgical treatment for SUI within 12 months of follow-up. Potential explanations include the use of alternative non-surgical treatments, the SUI not being severe enough to warrant surgery, or the woman's desire to avoid further surgery and operative risks. 14 Costantini et al. evaluated concomitant colposuspension at the time of abdominal sacrocolpopexy surgery versus sacrocolpopexy alone and showed no significant benefit in adding Burch colposuspension.15 Overall, there is sufficient evidence that for women who are symptomatic of SUI and POP, concomitant vaginal POP repair and anti-incontinence surgery is beneficial for reducing postoperative SUI. However, it must be borne in mind that in women undergoing vaginal POP surgery alone, almost one-third may experience cure of SUI symptoms and despite concomitant continence surgery, SUI can still persist in approximately one-third of women.16 So, we aim to compare the risk of surgical intervention for stress urinary incontinence after combined prolapse and anti-incontinence surgery and prolapse surgery alone.

RATIONALE:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
41 Years to 83 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adult females 41-83 years age presenting with concurrent prolapse and stress urinary incontinence willing to participate in the study.

Exclusion Criteria

  • - Exclusion criteria: Study exclusion criteria will be urge incontinence according to questionnaire, urinary tract infection, unwilling for surgery, unfit for surgery, urogenital malignancy, urolithiasis.

Outcomes

Primary Outcomes

symptomatic stress urinary incontinence requiring surgery at six months

Time Frame: at six months after surgery

Secondary Outcomes

  • quality of life parameters.It will be assessed using ICIQ-UI short form questionnaires(1 week,6 week and six month after surgery)

Investigators

Sponsor
Shalamar Institute of Health Sciences
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sheema Yousuf

Doctor

Shalamar Institute of Health Sciences

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