Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Sites may include patients with either the GYNECARE TVT SECUR System, GYNECARE TVT System, or the GYNECARE TVT Obturator System
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Standing cough stress test | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| I-QOL score | 3, 6, 12 and 24 months |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Women diagnosed with SUI who are suitable candidates for a TVT system, according the relevant Instructions for Use (IFU).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Robinson, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Permanente Medical Group | Downey | California | 91101 | United States | ||
| Milestone Medical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22014817 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| Englewood |
| Colorado |
| 80112 |
| United States |
| Specialists in Urology | Naples | Florida | 34102 | United States |
| Illinois Urogynecology LTD | Oak Lawn | Illinois | 60453 | United States |
| Michigan Institute of Women's Health | Dearborn | Michigan | 48124 | United States |
| Women's Health Center of West Michigan | Grand Rapids | Michigan | 49503 | United States |
| Female Pelvic Medicine & Reconstructive Surgery | Minneapolis | Minnesota | 55403 | United States |
| Sheldon J. Freedman MD | Las Vegas | Nevada | 89148 | United States |
| University of Rochester OB/Gyn Department | Rochester | New York | 14642 | United States |
| Seton Center, Good Samaritan Hospital | West Chester | Ohio | 45069 | United States |
| The Institute for Female Pelvic Medicine and Reconstructive Surgery | Allentown | Pennsylvania | 18104 | United States |
| Advanced Clinical Concepts | West Reading | Pennsylvania | 19611 | United States |
| Vanderbilt University Medical School | Nashville | Tennessee | 37232 | United States |
| Northern Virginia Pelvic Surgery Associates | Annandale | Virginia | 22003 | United States |
| Sound Urological Associates | Edmonds | Washington | 98026 | United States |
| The Townsville Hospital Department of Urogynaecology | Douglas | Australia |
| Gold Coast Health Service | Southport | Australia |
| Queen Elizabeth Hospital | Woodville | Australia |
| Abteilung fuer Gynaekologie | Mödling | Austria |
| Wentworth-Limeridge Medical Centre | Hamilton | Ontario | L9A 5H4 | Canada |
| Universitatsfrauenklinik | Tübingen | 72076 | Germany |
| Kandang Kerbau Women's and Children's Hospital | Singapore | 229 899 | Singapore |
| Kingsbury House | Cape Town | 7708 | South Africa |
| Pretoria Urology Hospital | Hatfield | 0028 | South Africa |
| Arwyp Hospital | Kempton | 1620 | South Africa |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Ulster Hospital Belfast | Belfast | United Kingdom |
| Stoke Mandeville Hospital | Buckinghamshire | HP21 8AL | United Kingdom |
| Glasgow Southern General | Glasgow | G51 4TF | United Kingdom |
| Leicester General Hospital | Leicester | LE5 4PW | United Kingdom |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided