Urinary Incontinence Clinical Trial
Official title:
TVT-SECUR as an Office-based Procedure - A Pilot Study
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 20 patients who will have the TVT-Secur procedure
done in the office under local anesthesia. They will be followed for a period of 1 year.
The study will include 20 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. Subjects are diagnosed with Stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. Subjects are women who no longer intend to bear children and who do not require any other concomitant surgery. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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