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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 is a Phase 2 study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 337 participants.
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.
Interventions
- OTHER Sham
- DEVICE TVT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 337 participants |
| Start Date | 2007-05 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00460434
The ClinicalTrials.gov registry entry for NCT00460434 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 337 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT00460434 reports 0 study locations.
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.
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