Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 180
- Woman over 18 years old
- Clinical diagnosis of stress urinary incontinence requiring surgical management
- Must be able to read and sign the consent
- 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)
CH Dunkerque
🇫🇷Dunkerque, France
Hôtel Dieu
🇫🇷Clermont-Ferrand, France
Hopital Antoine Beclere
🇫🇷Clamart, France
CH Rouen
🇫🇷Rouen, France
CHU Amiens
🇫🇷Amiens, France
CHU Pellegrin
🇫🇷Bordeaux, France
CH Chambery
🇫🇷Chambery, France
CH Caremeau
🇫🇷Nimes, France
Centre Hospitalier Universitaire
🇫🇷Angers, France
Chu Nancy
🇫🇷Nancy, France
Centre Hospitalier Paul Ardier
🇫🇷Issoire, France
Hopital Saint Andre
🇫🇷Bordeaux, France
CH Rennes
🇫🇷Rennes, France
Hopital Diaconesses Croix Saint Simon
🇫🇷Paris, France