Clinical trial NCT00453739: TVT Worldwide Registry
Official title: TVT-World Wide Observational Registry for Long-Term Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-29
Enrollment: 1407
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with SUI who are suitable candidates for a TVT system, according the relevant Instructions for Use (IFU).

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

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).

Primary outcomes:
measure: Standing cough stress test
timeFrame: 12 months
Secondary outcomes:
measure: I-QOL score
timeFrame: 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Downey
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Englewood
country: United States
facility: Milestone Medical Research
state: Colorado
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: Oak Lawn
country: United States
facility: Illinois Urogynecology LTD
state: Illinois
city: Dearborn
country: United States
facility: Michigan Institute of Women's Health
state: Michigan
city: Grand Rapids
country: United States
facility: Women's Health Center of West Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Female Pelvic Medicine & Reconstructive Surgery
state: Minnesota
city: Las Vegas
country: United States
facility: Sheldon J. Freedman MD
state: Nevada
city: Rochester
country: United States
facility: University of Rochester OB/Gyn Department
state: New York
city: West Chester
country: United States
facility: Seton Center, Good Samaritan Hospital
state: Ohio
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: West Reading
country: United States
facility: Advanced Clinical Concepts
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical School
state: Tennessee
city: Annandale
country: United States
facility: Northern Virginia Pelvic Surgery Associates
state: Virginia
city: Edmonds
country: United States
facility: Sound Urological Associates
state: Washington
city: Douglas
country: Australia
facility: The Townsville Hospital Department of Urogynaecology
city: Southport
country: Australia
facility: Gold Coast Health Service
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital
city: Moedling
country: Austria
facility: Abteilung fuer Gynaekologie
city: Hamilton
country: Canada
facility: Wentworth-Limeridge Medical Centre
state: Ontario
city: Tubingen
country: Germany
facility: Universitatsfrauenklinik
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Singapore
country: Singapore
facility: Kandang Kerbau Women's and Children's Hospital
city: Cape Town
country: South Africa
facility: Kingsbury House
city: Hatfield
country: South Africa
facility: Pretoria Urology Hospital
city: Kempton
country: South Africa
facility: Arwyp Hospital
city: Belfast
country: United Kingdom
facility: Ulster Hospital Belfast
city: Buckinghamshire
country: United Kingdom
facility: Stoke Mandeville Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Southern General
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
Study officials:
affiliation: Ethicon, Inc.
name: David Robinson, MD
role: STUDY_DIRECTOR
References:
citation: Tincello DG, Botha T, Grier D, Jones P, Subramanian D, Urquhart C, Kirkemo A, Khandwala S; TVT Worldwide Registry Investigators. The TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women. J Urol. 2011 Dec;186(6):2310-5. doi: 10.1016/j.juro.2011.07.078. Epub 2011 Oct 20.