TVT-SECUR as an Office-based Procedure (TVTSOffice)

Michigan Institution of Women's Health PC

Status: Completed

Conditions: Stress Urinary Incontinence; Urinary Incontinence

Treatments: Device: Gynecare TVT-SECUR system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01137539

MIWH08-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Gynecare TVT-SECUR system

Experimental group

Description:

All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence

Treatment:

Device: Gynecare TVT-SECUR system