TVT Worldwide Registry
- Conditions
- Stress Urinary Incontinence
- Registration Number
- NCT00453739
- Lead Sponsor
- Ethicon, Inc.
- Brief Summary
The objective of this observational study is to obtain long -term clinical and patient reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape) systems in women with stress urinary incontinence.
- Detailed Description
Sites may include patients with either the GYNECARE TVT SECUR System, GYNECARE TVT System, or the GYNECARE TVT Obturator System
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1407
- Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Standing cough stress test 12 months
- Secondary Outcome Measures
Name Time Method I-QOL score 3, 6, 12 and 24 months
Trial Locations
- Locations (30)
Female Pelvic Medicine & Reconstructive Surgery
🇺🇸Minneapolis, Minnesota, United States
Glasgow Southern General
🇬🇧Glasgow, United Kingdom
Universitatsfrauenklinik
🇩🇪Tubingen, Germany
Specialists in Urology
🇺🇸Naples, Florida, United States
Michigan Institute of Women's Health
🇺🇸Dearborn, Michigan, United States
Gold Coast Health Service
🇦🇺Southport, Australia
Queen Elizabeth Hospital
🇦🇺Woodville, Australia
Milestone Medical Research
🇺🇸Englewood, Colorado, United States
Abteilung fuer Gynaekologie
🇦🇹Moedling, Austria
Kandang Kerbau Women's and Children's Hospital
🇸🇬Singapore, Singapore
The Townsville Hospital Department of Urogynaecology
🇦🇺Douglas, Australia
Vanderbilt University Medical School
🇺🇸Nashville, Tennessee, United States
Advanced Clinical Concepts
🇺🇸West Reading, Pennsylvania, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Women's Health Center of West Michigan
🇺🇸Grand Rapids, Michigan, United States
Stoke Mandeville Hospital
🇬🇧Buckinghamshire, United Kingdom
Arwyp Hospital
🇿🇦Kempton, South Africa
Ulster Hospital Belfast
🇬🇧Belfast, United Kingdom
Wentworth-Limeridge Medical Centre
🇨🇦Hamilton, Ontario, Canada
Pretoria Urology Hospital
🇿🇦Hatfield, South Africa
Seton Center, Good Samaritan Hospital
🇺🇸West Chester, Ohio, United States
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Leicester General Hospital
🇬🇧Leicester, United Kingdom
Sheldon J. Freedman MD
🇺🇸Las Vegas, Nevada, United States
University of Rochester OB/Gyn Department
🇺🇸Rochester, New York, United States
The Institute for Female Pelvic Medicine and Reconstructive Surgery
🇺🇸Allentown, Pennsylvania, United States
Northern Virginia Pelvic Surgery Associates
🇺🇸Annandale, Virginia, United States
Sound Urological Associates
🇺🇸Edmonds, Washington, United States
Kingsbury House
🇿🇦Cape Town, South Africa
Illinois Urogynecology LTD
🇺🇸Oak Lawn, Illinois, United States