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

January 8, 2012 updated by: HaEmek Medical Center, Israel

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Dep of OG/GYN, Emek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control arm
vaginal wall repair surgery will be done to women in this arm, with no treatment for stress incontinence
Active Comparator: TVT-O arm
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
during the vaginal wall repair surgery, a TVT-O procedure will be done
Other Names:
  • GYNECARE TVT™ Obturator System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress incontinence
Time Frame: 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
One year post operation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

January 2, 2012

First Submitted That Met QC Criteria

January 8, 2012

First Posted (Estimate)

January 11, 2012

Study Record Updates

Last Update Posted (Estimate)

January 11, 2012

Last Update Submitted That Met QC Criteria

January 8, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0083-11EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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