Stress Urinary Incontinence Clinical Trial
Official title:
TVT-World Wide Observational Registry for Long-Term Data
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.
| Status | Completed |
| Enrollment | 1407 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU). |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Australia | The Townsville Hospital Department of Urogynaecology | Douglas | |
| Australia | Gold Coast Health Service | Southport | |
| Australia | Queen Elizabeth Hospital | Woodville | |
| Austria | Abteilung fuer Gynaekologie | Moedling | |
| Canada | Wentworth-Limeridge Medical Centre | Hamilton | Ontario |
| Germany | Universitatsfrauenklinik | Tubingen | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Singapore | Kandang Kerbau Women's and Children's Hospital | Singapore | |
| South Africa | Kingsbury House | Cape Town | |
| South Africa | Pretoria Urology Hospital | Hatfield | |
| South Africa | Arwyp Hospital | Kempton | |
| United Kingdom | Ulster Hospital Belfast | Belfast | |
| United Kingdom | Stoke Mandeville Hospital | Buckinghamshire | |
| United Kingdom | Glasgow Southern General | Glasgow | |
| United Kingdom | Leicester General Hospital | Leicester | |
| United States | The Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania |
| United States | Northern Virginia Pelvic Surgery Associates | Annandale | Virginia |
| United States | Michigan Institute of Women's Health | Dearborn | Michigan |
| United States | Southern California Permanente Medical Group | Downey | California |
| United States | Sound Urological Associates | Edmonds | Washington |
| United States | Milestone Medical Research | Englewood | Colorado |
| United States | Women's Health Center of West Michigan | Grand Rapids | Michigan |
| United States | Sheldon J. Freedman MD | Las Vegas | Nevada |
| United States | Female Pelvic Medicine & Reconstructive Surgery | Minneapolis | Minnesota |
| United States | Specialists in Urology | Naples | Florida |
| United States | Vanderbilt University Medical School | Nashville | Tennessee |
| United States | Illinois Urogynecology LTD | Oak Lawn | Illinois |
| United States | University of Rochester OB/Gyn Department | Rochester | New York |
| United States | Seton Center, Good Samaritan Hospital | West Chester | Ohio |
| United States | Advanced Clinical Concepts | West Reading | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Ethicon, Inc. |
United States, Australia, Austria, Canada, Germany, Korea, Republic of, Singapore, South Africa, United Kingdom,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Standing cough stress test | 12 months | No | |
| Secondary | I-QOL score | 3, 6, 12 and 24 months | No |
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