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NCT00325039 · ClinicalTrials.gov registry record · Phase 4
TOMUS-Trial Of Mid-Urethral Slings
A Phase 4 study, sponsored by Carelon Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 597
- Enrollment target
NCT00325039: Completed Phase 4 study, sponsored by Carelon Research.
NCT00325039 is a Phase 4 study that has completed, run by Carelon Research. The registered enrollment target is 597 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00325039, a Phase 4 study, has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 597 participants
- Enrollment target
Study Summary
The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years.
Primary Outcome
Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involun
Interventions
- PROCEDURE retropubic mid-urethral sling (TVT)
- PROCEDURE transobturator mid-urethral sling (TVT-O and the Monarc)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2006-04 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
What the finished NCT00325039 record still lists
NCT00325039 is an interventional study that assigns participants to a tested intervention. The registered 597 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which retropubic mid-urethral sling (TVT) is the first listed.
NCT00325039 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00325039 about?
NCT00325039 is a clinical study titled "TOMUS-Trial Of Mid-Urethral Slings". The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical pro...
What is the current status of trial NCT00325039?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 597 participants. The study started on 2006-04. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00325039?
The interventions under investigation include: retropubic mid-urethral sling (TVT) (PROCEDURE), transobturator mid-urethral sling (TVT-O and the Monarc) (PROCEDURE).
Who is sponsoring clinical trial NCT00325039?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00325039's enrollment target sits among peer trials
597 147th of 2000 higher than 1,854 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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