Phase 3
N=655
Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00064662 ↗Enrolled (actual)
655
Serious AEs
11.3%
Results posted
Sep 2012
Primary outcome: Primary: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). — 38; 47 % success at 24 months — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Burch Modified Tanagho (Procedure); Autologous Fascia Sling (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Carelon Research
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). |
38; 47 | 0.01 sig |
| PRIMARY 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) |
49; 66 | <0.001 sig |
Summary
The primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.
Eligibility Criteria
- Predominant stress urinary incontinence by self-report, examination and test;
- Urethral hypermobility;
- Eligible for both surgical procedures;
- Ambulatory;
- Not pregnant;
- >12 months post-partum;
- No systemic disease known to affect bladder function;
- No current chemotherapy or radiation therapy;
- No urethral diverticulum, augmentation cytoplasty, or artificial sphincter;
- No recent pelvic surgery;
- Available for follow-up and able to complete study assessments;
- Signed informed consent.
Data sourced from ClinicalTrials.gov (NCT00064662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.