TVT-SECUR as an Office-based Procedure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urinary Incontinence, Stress Urinary Incontinence

Intervention / Treatment
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* Device: Gynecare TVT-SECUR system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gynecare TVT-SECUR system<br>All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence | Device: Gynecare TVT-SECUR system<br>* All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence<br>* Other names: Mid-urethral sling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success Based on Patient Report on Validated Questionnaire | Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, Do you currently experience urine leakage related to physical activity, coughing or sneezing. If a subject answers No, this is considered success. If a subject answers Yes, this is considered failure of treatment. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Positive response to a satisfaction question | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TVT, urinary incontinence, stress urinary incontinence, mid-urethral slings, Tension-free vaginal taping