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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: Completed NA study of Urinary Incontinence and Stress Urinary Incontinence, sponsored by Michigan Institution of Women's Health PC.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, "Do you currently experience urine leakage related to physical activity, coughing or sneezing." If a subject answers "No", this is considered success. If a subject answers "Yes", this is considered failure of treatment.
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 |
What the finished NCT01137539 record still lists
NCT01137539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 261-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Urinary Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01137539's enrollment target sits among peer trials
50 32nd of 48 higher than 17 of 48 other Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Incontinence 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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