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NCT01137539 · ClinicalTrials.gov registry record · NA
TVT-SECUR as an Office-based Procedure
A NA study of Urinary Incontinence and Stress Urinary Incontinence, sponsored by Michigan Institution of Women's Health PC.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01137539 is a NA study of Urinary Incontinence and Stress Urinary Incontinence that has completed, run by Michigan Institution of Women's Health PC. The registered enrollment target is 50 participants, below the 261-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01137539, a NA study of Urinary Incontinence and Stress Urinary Incontinence, has completed, sponsored by Michigan Institution of Women's Health PC.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires. This is a prospective single arm study of 50 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 3 years.
Conditions Studied
Interventions
- DEVICE Gynecare TVT-SECUR system
Study Locations (1)
Michigan
- Advanced Urogynecology of Michigan PC - Dearborn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-10 |
| Est. Completion | 2012-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01137539
The ClinicalTrials.gov registry entry for NCT01137539 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (81% lower). The listed sponsor is Michigan Institution of Women's Health PC, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Urinary Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Gynecare TVT-SECUR system is the first listed.
NCT01137539 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT01137539 about?
NCT01137539 is a clinical study titled "TVT-SECUR as an Office-based Procedure". This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires. This is a prospective single arm st...
What is the current status of trial NCT01137539?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2008-10. Estimated completion is 2012-10.
What conditions does trial NCT01137539 study?
This clinical trial studies the following conditions: Urinary Incontinence, Stress Urinary Incontinence.
What interventions are being tested in trial NCT01137539?
The interventions under investigation include: Gynecare TVT-SECUR system (DEVICE).
Who is sponsoring clinical trial NCT01137539?
This trial is sponsored by Michigan Institution of Women's Health PC, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01137539 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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