A randomised trial of open versus laparoscopic colposuspension for genuine stress incontinence
Completed
- Conditions
- Stress incontinenceUrological and Genital Diseases
- Registration Number
- ISRCTN14969683
- Lead Sponsor
- Medical Research Council (MRC) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 290
Inclusion Criteria
1. Any woman for whom a decision has been made to perform a colposuspension for cystometrically proven genuine stress incontinence.
2. Women who have had an anterior colporrhaphy would be eligible as it is considered that their inclusion is pragmatic reflecting everyday practice.
Exclusion Criteria
1. Women in whom bladder neck surgery is contraindicated;
2. Women with detrusor instability.
3. Women who have had previous retropubic bladder neck surgery (colposuspension or sling procedure) or sacrocolpopexy.
4. Women who are unhappy to be randomised to laparoscopic colposuspension.
5. Women considered too obese for open colposuspension. (Laparoscopic colposuspension is only to be available as part of the trial.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcomes: complete cure of stress incontinence at 24 and 48 months. Symptom improvement classified as: Complete (have never leaked since surgery and no leakage objectively demonstrated), <br>Acceptable Improvement (matched patient expectations), Inadequate Improvement, No improvement, Worse. Levels of significant operative morbidity.
- Secondary Outcome Measures
Name Time Method ot provided at time of registration