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

Phase 4

• Conditions: Urinary Incontinence, Stress

• Registration Number: NCT00135616
• Lead Sponsor: Hopital Antoine Beclere

Brief Summary

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.

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 Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-26
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-27
• Last Update Posted: 2007-04-30
• Study Completion: 2008-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pre operative complication: rate of bladder perforation
post operative complication: rate of post-operative pain

Secondary Outcome Measures

Name	Time	Method
efficacy: disparation of urinary incontinence
safety: sexual behaviour

Trial Locations

Locations (14)

CHU Amiens; 🇫🇷 Amiens, France

Centre Hospitalier Universitaire; 🇫🇷 Angers, France

CHU Pellegrin; 🇫🇷 Bordeaux, France

Hopital Saint Andre; 🇫🇷 Bordeaux, France

CH Chambery; 🇫🇷 Chambery, France

Hopital Antoine Beclere; 🇫🇷 Clamart, France

Hôtel Dieu; 🇫🇷 Clermont-Ferrand, France

CH Dunkerque; 🇫🇷 Dunkerque, France

Centre Hospitalier Paul Ardier; 🇫🇷 Issoire, France

Chu Nancy; 🇫🇷 Nancy, France

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