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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01029106
Study type	Observational
Source	Sunnybrook Health Sciences Centre
Contact
Status	Terminated
Phase	N/A
Start date	September 2009

View Details

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