CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Gynecare TVT-SECUR systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01137539
NCT01137539N/ACompleted
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TVT-SECUR as an Office-based Procedure - A Pilot Study

Michigan Institution of Women's Health PC·interventional·Posted Jun 4, 2010·Updated Jun 28, 2017

In Brief

A clinical study evaluating Gynecare TVT-SECUR system for Urinary Incontinence and Stress Urinary Incontinence. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence, Stress Urinary Incontinence
CountriesUnited States
CollaboratorsEthicon, Inc.

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2010
Enrollment StartOct 1, 2008
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.1 years ago

Interventions

Gynecare TVT-SECUR systemdevice

All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence