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NCT00064662 · ClinicalTrials.gov registry record · Phase 2
Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence
A Phase 2 study of Urinary Incontinence, sponsored by Carelon Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 655
- Enrollment target
- 9
- Study locations
NCT00064662: Completed Phase 2 study of Urinary Incontinence, sponsored by Carelon Research.
NCT00064662 is a Phase 2 study of Urinary Incontinence that has completed, run by Carelon Research. The registered enrollment target is 655 participants, above the 248-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (164% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00064662, a Phase 2 study of Urinary Incontinence, has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 655 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
Success defined as composite measure including: no self-reported incontinence symptoms reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire, \<15g in pad weight during 24 hr pad test, no incontinence episodes on 3-day voiding diary, negative results (no leakage) on provocative stress test at standardized bladder volume, no retreatment for urinary incontinence. Additional treatment for stress urinary incontinence (SUI) includes anti-incontinence surgery
Conditions Studied
Interventions
- PROCEDURE Burch Modified Tanagho
- PROCEDURE Autologous Fascia Sling
Study Locations (9)
Texas
- University of Texas, Southwestern - Dallas
- University of Texas Health Sciences Center - San Antonio
Alabama
- University of Alabama - Birmingham
California
- University of California - San Diego
Illinois
- Loyola University Medical Center - Maywood
Maryland
- University of Maryland - Baltimore
Michigan
- Beaumont Hospital - Royal Oak
Pennsylvania
- University of Pittsburgh - Pittsburgh
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 655 participants |
| Start Date | 2002-02 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00064662 record still lists
NCT00064662 is an interventional study that assigns participants to a tested intervention. The registered 655 participants enrollment target is mid-sized for trials with a published cap, above the 248-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (164% higher).
The record links to 1 condition, with Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Burch Modified Tanagho is the first listed.
NCT00064662 lists 9 locations in 8 states (Texas, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT00064662 about?
NCT00064662 is a clinical study titled "Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence". 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 com...
What is the current status of trial NCT00064662?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 655 participants. The study started on 2002-02. Estimated completion is 2010-03.
What conditions does trial NCT00064662 study?
This clinical trial studies the following conditions: Urinary Incontinence.
What interventions are being tested in trial NCT00064662?
The interventions under investigation include: Burch Modified Tanagho (PROCEDURE), Autologous Fascia Sling (PROCEDURE).
Who is sponsoring clinical trial NCT00064662?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00064662 being conducted?
This trial has 9 study locations across Alabama, California, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Urinary Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00064662's enrollment target sits among peer trials
655 6th of 48 higher than 43 of 48 other Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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