NCT01137539

TVT-SECUR as an Office-based Procedure

TVT-SECUR as an Office-based Procedure - A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Michigan Institution of Women's Health PC · Academic / Other
• Sex: Female
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Urinary Incontinence
• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Gynecare TVT-SECUR system	All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-06-04
• Last updated: 2017-06-28
• Results posted: 2017-06-28

Locations

1 site across 1 country: United States