Phase 3 Completed N=655 Randomized Treatment

Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence

Urinary Incontinence

Source: ClinicalTrials.gov NCT00064662 ↗

Enrolled (actual)

655

Serious AEs

11.3%

Results posted

Sep 2012

Primary outcomePrimary: 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

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.

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

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.