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NCT00460434 · ClinicalTrials.gov registry record · Phase 2
Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial
A Phase 2 study, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 337
- Enrollment target
NCT00460434: Completed Phase 2 study, sponsored by NICHD Pelvic Floor Disorders Network.
NCT00460434 is a Phase 2 study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 337 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (153% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00460434, a Phase 2 study, has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 337 participants
- Enrollment target
Study Summary
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT)® at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence.
Primary Outcome
Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.
Interventions
- OTHER Sham
- DEVICE TVT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 337 participants |
| Start Date | 2007-05 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
What the finished NCT00460434 record still lists
NCT00460434 is an interventional study that assigns participants to a tested intervention. The registered 337 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (153% higher).
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT00460434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00460434 about?
NCT00460434 is a clinical study titled "Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial". Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial has shown that u...
What is the current status of trial NCT00460434?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 337 participants. The study started on 2007-05. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00460434?
The interventions under investigation include: Sham (OTHER), TVT (DEVICE).
Who is sponsoring clinical trial NCT00460434?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00460434's enrollment target sits among peer trials
337 141st of 2000 higher than 1,860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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