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NCT00534365 · ClinicalTrials.gov registry record · Phase 3
Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence
A Phase 3 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 281
- Enrollment target
NCT00534365: Completed Phase 3 study, sponsored by The Cleveland Clinic.
NCT00534365 is a Phase 3 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 281 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00534365, a Phase 3 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 281 participants
- Enrollment target
Study Summary
The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.
Primary Outcome
Composite outcome defined as absence of urinary incontinence as indicated by the Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment of stress urinary incontinence (SUI) after the index surgery.
Interventions
- DEVICE tension-free vaginal tape
- DEVICE TVT-SECUR device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2007-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT00534365 record still lists
NCT00534365 is an interventional study that assigns participants to a tested intervention. The registered 281 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which tension-free vaginal tape is the first listed.
NCT00534365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00534365 about?
NCT00534365 is a clinical study titled "Study Comparing TVT With TVT-SECUR for the Treatment of Stress Urinary Incontinence". The purpoe of this study is to compare the safety and efficacy of the tension-free vaginal tape procedure (TVT) to the TVT-SECUR procedure in the treatment of stress urinary incontinence.
What is the current status of trial NCT00534365?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 281 participants. The study started on 2007-08. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00534365?
The interventions under investigation include: tension-free vaginal tape (DEVICE), TVT-SECUR device (DEVICE).
Who is sponsoring clinical trial NCT00534365?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00534365's enrollment target sits among peer trials
281 1194th of 2000 higher than 806 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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