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Retropubic (TVT) versus transobturator (TVT-O) tension-free vaginal tape: five-year results of the Austrian randomized trial
Objective: Five year results of a randomized controlled trial comparing objective and subjective outcomes of TVT with those of TVT-O as primary treatment for stress urinary incontinence. Methods: Prospective, randomized controlled trial at 25 centers in Austria and Germany ( ClinicalTrials.gov NCT 0...
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Main Authors: | , , , , , , , , , , , |
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Format: | Conference Proceeding |
Language: | eng ; ger |
Online Access: | Get full text |
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Summary: | Objective:
Five year results of a randomized controlled trial comparing objective and subjective outcomes of TVT with those of TVT-O as primary treatment for stress urinary incontinence.
Methods:
Prospective, randomized controlled trial at 25 centers in Austria and Germany (
ClinicalTrials.gov
NCT 00441454). Clinical, urodynamic and quality of life assessment was performed preoperatively and 5 years after surgery. Statistical analysis: intention to treat, per protocol; chi-square test, t-test, Fisher's exact test, ANOVA.
Results:
A total of 569 women were randomized to retropubic or transobturator TVT and 331 patients (60%) were examined at 5 years. No statistical significant differences were seen in negative cough stress (83% vs. 76%, respectively), complications and urodynamic parameters. Quality-of-life parameters improved significantly in both groups, without significant differences between groups. Reoperation rates were 6.1% and 3.2%, erosion rates were 5.2% and 4.1%, respectively.
Conclusion
: Although the study did not meet its follow-up goal, the long-term results of this randomized trial indicate satisfactory and stable long-term results and improved Quality of Life with both the retropubic and the transobturator TVT. Major long-term problems appear rare. |
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ISSN: | 0016-5751 1438-8804 |
DOI: | 10.1055/s-0034-1374751 |