Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Prospective, Non-Randomized, Observational, Multicentre, Study of the TVT Secur in the Surgical Management of Women With Stress Urinary Incontinence|
- The primary endpoints are the cure/improvement rate in the cohort at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Distribution of percentage of subjects having a decrease of pad weight as compared to baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Decrease in number of pads used within a 24-hour period as compared to baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Change in patient questionnaires from baseline [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Change in the sling position on transvaginal ultrasound [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Cure/improvement rate at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Procedure: Gynecare TVT Secur
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029106
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Sender Herschorn, MD||Sunnybrook Health Sciences Centre|