Stress incontinence Urological and Genital Diseases Stress incontinence
Conditions
Interventions
The interventions under study will be open or laparoscopic colposuspension.
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Inclusion criteria
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
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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), Acceptable Improvement (matched patient expectations), Inadequate Improvement, No improvement, Worse. Levels of significant operative morbidity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed