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Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.Patients in the study will have an operation to improve urinary incontinence symptoms. This will involve inserting a mesh sling to help support the urethra (tube leading into your bladder). During the operation, the study doctor will use tension-free vaginal obturator system. The study will include women diagnosed with Stress Urinary Incontinence who have completed their families.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tension-free vaginal tape obturator system | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Overall incidence of treatment success. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of unresolved de novo urgency post-treatment. | ||
| No additional surgery required to correct SUI post-treatment | ||
| Intraoperative and postoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
For patients having URP measurements at selected sites:
Carefully place a half of a speculum into the vagina, reducing prolapse to less than stage 1. Be careful not to over extend or elongate the vaginal length.
The half of a speculum must be placed with pressure emphasis on the posterior and apical areas. Anterior wall pressure or urethral pressure must be avoided at all times.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Weisberg, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urogynecology Associates of CO | Denver | Colorado | 80220 | United States | ||
| Bladder Control Center |
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| Quality-of-life measurements |
| Return to usual activity |
| Patient satisfaction |
| Norwalk |
| Connecticut |
| 06850 |
| United States |
| Urogynecology Specialists of Kenuckiana | Louisville | Kentucky | 40207 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Oakwood Hospital | Dearborn | Michigan | 48123 | United States |
| Sheldon Freedman, MD | Las Vegas | Nevada | 89109 | United States |
| St. Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| The Institute for Female Pelvic Medicine & Reconstructive Surgery | Allentown | Pennsylvania | 18104 | United States |
| University Urology | Knoxville | Tennessee | 37920 | United States |
| McDonlad Murrmann Women's Clinic | Memphis | Tennessee | 38120 | United States |
| Sound Urology Ambulatory Surgery Center | Edmonds | Washington | 98026 | United States |
| Sunnybrook & Women's College Health Sciences Center | Toronto | Ontario | M2L 1V7 | Canada |
| Service d'Urologie | Marseille | 13015 | France |
| Hopital Des Diaconesses | Paris | 75571 | France |
| Klinikum der Eberhard-Karls-Universität | Tübingen | D-72706 | Germany |
| Women's and Children's Hospital | Singapore | 229 899 | Singapore |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| University of Ulsan College of Medicine and Asan Medical Center | Seoul | South Korea |
| Southport District General Hospital | Southport | PR8 6PN | 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 |
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