Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach

April 27, 2007 updated by: Hopital Antoine Beclere

Randomized Controlled Study Comparing Two Types of Suburethral Slings for the Surgical Treatment of Female Stress Incontinence : TVT and TVT-O.

The purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Urinary stress incontinence (USI) is a frequent pathology in women. Surgical treatment is required in 30 to 50% of women presenting with USI. Several surgical techniques are currently available.

At the present time, the placement of suburethral slings is one of the most efficient techniques. Furthermore, the placement of a suburethral sling is known to be associated with a low rate of complications.

Currently, two approaches are available for the placement of a suburethral sling: retropubic approach (TVT) and trans-obturator approach (TVT-O). The efficacy of these two approaches seem equivalents. However, the morbidity related to these two techniques is probably different. In retrospective studies, the retropubic approach is associated with a higher rate of bladder perforation. On the other hand, the trans-obturator approach is supposed to be associated with a higher rate of post-operative pain.

Thus, the purpose of this study is to compare efficacy and morbidity following the placement of two types of suburethral slings in women presenting with stress urinary incontinence: TVT and TVT-O.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

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

  • France
      • Amiens, France, 80000
        • CHU Amiens
      • Angers, France, 49000
        • Centre Hospitalier Universitaire
      • Bordeaux, France, 33000
        • CHU Pellegrin
      • Bordeaux, France, 33000
        • Hopital Saint André
      • Chambery, France, 73000
        • CH Chambéry
      • Clamart, France, 92140
        • Hôpital Antoine Béclère
      • Clermont-Ferrand, France, 63058
        • Hôtel Dieu
      • Dunkerque, France, 59000
        • CH Dunkerque
      • Issoire, France, 63500
        • Centre Hospitalier Paul Ardier
      • Nancy, France
        • CHU Nancy
      • Nimes, France, 30000
        • CH Caremeau
      • Paris, France, 75012
        • Hopital Diaconesses Croix Saint Simon
      • Rennes, France, 35000
        • Ch Rennes
      • Rouen, France, 76000
        • CH Rouen

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

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Woman over 18 years old
  • Clinical diagnosis of stress urinary incontinence requiring surgical management
  • Must be able to read and sign the consent

Exclusion Criteria:

  • Pregnancy
  • Anti-coagulant treatment
  • Isolated overactive bladder syndrome
  • Genital prolapse requiring surgical treatment
  • Concomitant hysterectomy

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
pre operative complication: rate of bladder perforation
post operative complication: rate of post-operative pain

Secondary Outcome Measures

Outcome Measure
efficacy: disparation of urinary incontinence
safety: sexual behaviour

Collaborators and Investigators

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

Sponsor

Hopital Antoine Beclere

Investigators

  • Principal Investigator: Xavier Deffieux, MD, Hôpital Antoine Béclère, Clamart, France

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

March 1, 2005

Study Completion (ANTICIPATED)

March 1, 2008

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (ESTIMATE)

August 26, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 30, 2007

Last Update Submitted That Met QC Criteria

April 27, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xd01

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.

Subscribe