Status:
UNKNOWN
Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach
Lead Sponsor:
Hopital Antoine Beclere
Conditions:
Urinary Incontinence, Stress
Eligibility:
FEMALE
18-95 years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- Woman over 18 years old
- Clinical diagnosis of stress urinary incontinence requiring surgical management
- Must be able to read and sign the consent
Exclusion
- Pregnancy
- Anti-coagulant treatment
- Isolated overactive bladder syndrome
- Genital prolapse requiring surgical treatment
- Concomitant hysterectomy
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00135616
Start Date
March 1 2005
End Date
March 1 2008
Last Update
April 30 2007
Active Locations (14)
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1
CHU Amiens
Amiens, France, 80000
2
Centre Hospitalier Universitaire
Angers, France, 49000
3
CHU Pellegrin
Bordeaux, France, 33000
4
Hopital Saint Andre
Bordeaux, France, 33000