Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)
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|ClinicalTrials.gov Identifier: NCT01029106|
Recruitment Status : Terminated (Study design required a change in device)
First Posted : December 9, 2009
Last Update Posted : July 28, 2011
This is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operative procedure.
The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires, Intraoperative procedural data will be collected.
Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals up to 24 months. The anatomic position of the device will be characterize by transvaginal ultrasound testing.
To determine the rate and/or improvement rate of patients who have received the Gynecare Secur device after 12 months and after 24 months.
|Condition or disease||Intervention/treatment|
|Stress Urinary Incontinence||Procedure: Gynecare TVT Secur|
|Study Type :||Observational|
|Estimated Enrollment :||125 participants|
|Official Title:||Prospective, Non-Randomized, Observational, Multicentre, Study of the TVT Secur in the Surgical Management of Women With Stress Urinary Incontinence|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2012|
Procedure: Gynecare TVT Secur
- The primary endpoints are the cure/improvement rate in the cohort at 12 months. [ Time Frame: 12 months ]
- Distribution of percentage of subjects having a decrease of pad weight as compared to baseline [ Time Frame: 24 months ]
- Decrease in number of pads used within a 24-hour period as compared to baseline [ Time Frame: 24 months ]
- Change in patient questionnaires from baseline [ Time Frame: 24 months ]
- Change in the sling position on transvaginal ultrasound [ Time Frame: 24 months ]
- Cure/improvement rate at 24 months [ Time Frame: 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029106
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Sender Herschorn, MD||Sunnybrook Health Sciences Centre|