TVT-SECUR as an Office-based Procedure (TVTSOffice)
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.
|Urinary Incontinence Stress Urinary Incontinence||Device: Gynecare TVT-SECUR system|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||TVT-SECUR as an Office-based Procedure - A Pilot Study|
- Treatment Success Based on Patient Report on Validated Questionnaire [ Time Frame: 24 months ]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.
- Patient Satisfaction [ Time Frame: 12 months ]Positive response to a satisfaction question
|Study Start Date:||October 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Gynecare TVT-SECUR system
All patients enrolled into the study will receive the TVT-SECUR system to treat stress urinary incontinence
Device: Gynecare TVT-SECUR system
All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137539
|United States, Michigan|
|Advanced Urogynecology of Michigan PC|
|Dearborn, Michigan, United States, 48124|
|Principal Investigator:||Salil S Khandwala, MD||Michigan Institute of Women's Health PC|