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The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TVT and TVT-O minimally invasive surgical procedures | Procedure | |||
| Surgery for female stress urinary incontinence | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | ||
| Objective cure rate by stress test and pad weighing test |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl G Nilsson, MD,PhD | Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital | Principal Investigator |
| Carl G Nilsson, MD,PhD | University of Helsinki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University, Dept Obstet Gynecol, Helsinki University Central Hospital | Helsinki | 00029 HUS | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11942891 | Background | Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7. doi: 10.1034/j.1600-0412.2002.810113.x. | |
| 24508070 | Derived | Laurikainen E, Valpas A, Aukee P, Kivela A, Rinne K, Takala T, Nilsson CG. Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. Eur Urol. 2014 Jun;65(6):1109-14. doi: 10.1016/j.eururo.2014.01.031. Epub 2014 Jan 31. |
| Label | URL |
|---|---|
| International urogynecological association | View source |
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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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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| 17197581 | Derived | Laurikainen E, Valpas A, Kivela A, Kalliola T, Rinne K, Takala T, Nilsson CG. Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2007 Jan;109(1):4-11. doi: 10.1097/01.AOG.0000249607.82768.a1. |
| 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 |