TVT-SECUR as an Office-based Procedure

Completed · Not applicable

Conditions studied: Urinary Incontinence, Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT01137539

Run by

Michigan Institution of Women's Health PC

People needed

50

Starts

2008-10-01

Expected to finish

2012-10-01

Last updated by the study team

2017-06-28

Who can join

Age: 21 and older, up to 89. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Stress urinary incontinence with hypermobility of the UV junction
• ASA I or II
• Age 21-89

You may not qualify if…

• Prior anti-incontinence surgery
• Not completed childbearing
• ASA III or higher
• Need concomitant surgery
• Poor compliance for office based approach

Where it is running

• Advanced Urogynecology of Michigan PC — Dearborn, Michigan, United States

Full record on ClinicalTrials.gov

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