NCT01029106

Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)

Prospective, Non-Randomized, Observational, Multicentre, Study of the TVT Secur in the Surgical Management of Women With Stress Urinary Incontinence

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	Gynecare TVT Secur	Implant of the Gynecare TVT Secur

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-09-01
• First posted: 2009-12-09
• Last updated: 2011-07-28

Locations

1 site across 1 country: Canada