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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 is a Phase 4 study that has completed, run by Carelon Research. The registered enrollment target is 597 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00325039
The ClinicalTrials.gov registry entry for NCT00325039 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 597 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 50 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which retropubic mid-urethral sling (TVT) is the first listed.
NCT00325039 reports 0 study locations.
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.
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