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)
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Milestone Medical Research
🇺🇸Englewood, Colorado, United States
Specialists in Urology
🇺🇸Naples, Florida, United States
Illinois Urogynecology LTD
🇺🇸Oak Lawn, Illinois, United States
Michigan Institute of Women's Health
🇺🇸Dearborn, Michigan, United States
Women's Health Center of West Michigan
🇺🇸Grand Rapids, Michigan, United States
Female Pelvic Medicine & Reconstructive Surgery
🇺🇸Minneapolis, Minnesota, United States
Sheldon J. Freedman MD
🇺🇸Las Vegas, Nevada, United States
University of Rochester OB/Gyn Department
🇺🇸Rochester, New York, United States
Seton Center, Good Samaritan Hospital
🇺🇸West Chester, Ohio, United States
Scroll for more (20 remaining)Southern California Permanente Medical Group🇺🇸Downey, California, United States