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NCT00475839 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Tension-free Vaginal Tape With the Monarc Procedure for Stress Urinary Incontinence
A Phase 3 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
NCT00475839 is a Phase 3 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 180 participants.
The verdict
NCT00475839, a Phase 3 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
Study Summary
Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed for recurrences. Many different surgical procedures have been described for the treatment of SUI and there is no general agreement as to the most effective. This study compares the safety and efficacy of the tension-free vaginal tape procedure to the Monarc subfascial hammock procedure in the treatment of stress urinary incontinence.
Interventions
- DEVICE Tension-free Vaginal Tape
- DEVICE Monarc sub-fascial hammock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2004-12 |
| Est. Completion | 2007-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00475839
The ClinicalTrials.gov registry entry for NCT00475839 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tension-free Vaginal Tape is the first listed.
NCT00475839 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00475839 about?
NCT00475839 is a clinical study titled "Study Comparing Tension-free Vaginal Tape With the Monarc Procedure for Stress Urinary Incontinence". Urinary incontinence is a major health issue in women. It is estimated to affect 30 - 40% of older women. Stress urinary incontinence, the most common form of this disease, is treated primarily with surgery. A woman's lifetime risk of surgery for SUI is 4%, with nearly 1/3 of surgery being performed...
What is the current status of trial NCT00475839?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2004-12. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00475839?
The interventions under investigation include: Tension-free Vaginal Tape (DEVICE), Monarc sub-fascial hammock (DEVICE).
Who is sponsoring clinical trial NCT00475839?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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