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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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This is a prospective, comparative randomized controled trial. The general purposes of this study is to compare the efficacy and safety of TVTO™ and TVTSecur™ as surgical treatment for female urinary stress incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TVT-O | Active Comparator | Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA). |
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| TVT-S | Active Comparator | Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TVT-O | Device | Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Maria HM BIANCHI, FELLOW | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Sao Paulo - Unifesp | São Paulo | São Paulo | 0-4023- 062 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37888839 | Derived | Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4. | |
| 24643378 | Derived | Bianchi-Ferraro AM, Jarmy-DiBella ZI, de Aquino Castro R, Bortolini MA, Sartori MG, Girao MJ. Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results. Int Urogynecol J. 2014 Oct;25(10):1343-8. doi: 10.1007/s00192-014-2352-7. Epub 2014 Mar 19. |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| TVT-S | Device | Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA). |
|
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| 23208003 | Derived | Bianchi-Ferraro AM, Jarmy-Di Bella ZI, Castro Rde A, Bortolini MA, Sartori MG, Girao MJ. Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2013 Sep;24(9):1459-65. doi: 10.1007/s00192-012-1998-2. Epub 2012 Dec 4. |
| 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 |