Status:
COMPLETED
TVT-SECUR as an Office-based Procedure
Lead Sponsor:
Michigan Institution of Women's Health PC
Collaborating Sponsors:
Ethicon, Inc.
Conditions:
Urinary Incontinence
Stress Urinary Incontinence
Eligibility:
FEMALE
21-89 years
Phase:
NA
Brief 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 pr...
Detailed Description
The study will include 50 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hy...
Eligibility Criteria
Inclusion
- Stress urinary incontinence with hypermobility of the UV junction
- ASA I or II
- Age 21-89
Exclusion
- Prior anti-incontinence surgery
- Not completed childbearing
- ASA III or higher
- Need concomitant surgery
- Poor compliance for office based approach
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01137539
Start Date
October 1 2008
End Date
October 1 2012
Last Update
June 28 2017
Active Locations (1)
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1
Advanced Urogynecology of Michigan PC
Dearborn, Michigan, United States, 48124