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

Not Applicable

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Preventive transobturator tension free vaginal tape

• Registration Number: NCT01507714
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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

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.

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-08
• Last Update Submitted: 2012-01-08
• Study First Posted: 2012-01-11
• Last Update Posted: 2012-01-11
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TVT-O arm	Preventive transobturator tension free vaginal tape	the women in this arm will have a TVT-O procedure in addition to the vaginal wall repair

Primary Outcome Measures

Name	Time	Method
Stress incontinence	One year post operation	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

Secondary Outcome Measures

Name	Time	Method
Surgical complications	one year	Surgical complication
post surgery urgency or urge incontinence	one year	urgency or urge incontinence

Trial Locations

Locations (1)

Dep of OG/GYN, Emek Medical Center; 🇮🇱 Afula, Israel