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NCT00934999 · ClinicalTrials.gov registry record · Phase 4
Comparison of Burch Urethropexy and Mid-urethral Sling Performed Concomitantly With a Sacral Colpopexy
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 113
- Enrollment target
NCT00934999: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT00934999 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 113 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00934999, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 113 participants
- Enrollment target
Study Summary
I. Specific Aims Pelvic organ prolapse is a common and distressing condition that is frequently associated with stress urinary incontinence (SUI) and often requires surgical repair. Abdominal sacral colpopexy is the preferred operation for repairing pelvic prolapse. As many as 91% of women with pelvic organ prolapse undergoing sacral colpopexy also experience SUI. In addition, up to 44% of previously continent women develop SUI incontinence after sacral colpopexy: perhaps because a sacral colpopexy may predispose to opening of the bladder neck if secured too tightly. The selection of a surgical procedure to prevent and manage SUI in women undergoing sacral colpopexy is empiric rather than evidence-based. Conceptually, a mid-urethral sling may be more effective than a Burch procedure for preventing urinary leakage because a sling provides outlet resistance beyond the bladder neck and therefore it may compensate for a downward tension on the bladder neck resulting from the sacral colpopexy. Indeed, clinical observations suggest that a mid-urethral sling is effective among women who have persistent urinary incontinence after sacral colpopexy with a Burch procedure. Therefore, the investigators' global hypothesis is that a mid-urethral sling is preferable to a Burch procedure for preventing and improving stress urinary incontinence in women undergoing sacral colpopexy for pelvic organ prolapse. The investigators' SPECIFIC AIMS are to evaluate objective and subjective outcomes at 6, 12 and 24 months in 124 women with urinary incontinence and advanced pelvic organ prolapse. All women will be undergoing a sacral colpopexy and will be randomized to either a Burch procedure or a mid-urethral sling. The primary endpoint is composite continence at 6 months while secondary endpoints will include composite continence and subjective measures of incontinence, patient satisfaction and morbidity associated with these procedures. The investigators' hypotheses are as follows: 1. At
Interventions
- PROCEDURE Burch urethropexy
- PROCEDURE Synthetic mid-urethral sling (TVT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2009-06 |
| Est. Completion | 2015-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00934999
The ClinicalTrials.gov registry entry for NCT00934999 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Burch urethropexy is the first listed.
NCT00934999 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00934999 about?
NCT00934999 is a clinical study titled "Comparison of Burch Urethropexy and Mid-urethral Sling Performed Concomitantly With a Sacral Colpopexy". I. Specific Aims Pelvic organ prolapse is a common and distressing condition that is frequently associated with stress urinary incontinence (SUI) and often requires surgical repair. Abdominal sacral colpopexy is the preferred operation for repairing pelvic prolapse. As many as 91% of women with pel...
What is the current status of trial NCT00934999?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 113 participants. The study started on 2009-06. Estimated completion is 2015-10.
What interventions are being tested in trial NCT00934999?
The interventions under investigation include: Burch urethropexy (PROCEDURE), Synthetic mid-urethral sling (TVT) (PROCEDURE).
Who is sponsoring clinical trial NCT00934999?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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