TVT-SECUR as an Office-based Procedure (TVTSOffice)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01137539|
Recruitment Status : Completed
First Posted : June 4, 2010
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence Stress Urinary Incontinence||Device: Gynecare TVT-SECUR system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TVT-SECUR as an Office-based Procedure - A Pilot Study|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|