Anterior Vaginal Wall Repair With Mesh in Combination With TVT-O to Reduce Urinary Stress Incontinence

Study Overview
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Brief Summary
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Urinary stress incontinence is defined as leakage of urine during stress. Urinary stress incontinence is a health problem with social, economic and psychological consequences. The appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence. The aim of this study is to examine the efficacy of transobturator tension free vaginal tape (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.

Detailed Description
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Urinary stress incontinence is defined as leakage of urine during stress (cough, lough, sneezing, coitus, heavy lifting, physical activity). Urinary stress incontinence is a health problem with social, economic and psychological consequences. The appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence. The CARE study has examined the efficacy of preventive BURCH RETROPUBIC URETHROPEXY among women who underwent abdominal sacrocolpopexy. According to this study, the BURCH procedure reduced the rate of post surgery urinary stress incontinence. The authors recommend to offer those women the preventive surgery. Those results cannot be relied on when considering vaginal wall repair by the vaginal approach. The aim of this study is to examine the efficacy of transobturator tension free vaginal tape (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.

Official Title
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Anterior Vaginal Wall Repair With Mesh in Combination With TVT-O to Reduce Urinary Stress Incontinence

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Preventive transobturator tension free vaginal tape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with vaginal wall prolapse grade 2 and more no contraindication to vaginal wall repair or tvt-o No stress incontinence Exclusion Criteria: urinary tract malformations past urinary stress incontinence surgical procedure UDI - question 17 or 18 - positive answer Occult urinary stress incontinence

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control arm<br>vaginal wall repair surgery will be done to women in this arm, with no treatment for stress incontinence | |
| Active Comparator: TVT-O arm<br>the women in this arm will have a TVT-O procedure in addition to the vaginal wall repair | Procedure: Preventive transobturator tension free vaginal tape<br>* during the vaginal wall repair surgery, a TVT-O procedure will be done<br>* Other names: GYNECARE TVT™ Obturator System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress incontinence | The women will be classified as continent or not continent according to: the Pelvic Floor Distress Inventory stress test need to other treatment for stress incontinence | One year post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Surgical complication | one year | 
| post surgery urgency or urge incontinence | urgency or urge incontinence | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preventive, tvt-o, stress incontinence