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TVT-O vs. TVT for the treatment of SUI: a non-inferiority study.

机译:TVT-O与TVT用于治疗SUI:一个非劣等的研究。

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INTRODUCTION AND HYPOTHESIS: This study aimed to prospectively compare, in terms of efficacy and safety, the tension-free vaginal tape (TVT) and the transobturator vaginal tape inside-out (TVT-O) procedure for stress urinary incontinence. METHODS: A cough stress test was applied to the objective outcomes, while urinary incontinence-specific quality of life questionnaire was applied to the subjective outcomes. A test for non-inferiority was carried out for detecting the success rate between the two groups. RESULTS: The objective success rates were found to be 95.4% (62/65) in the TVT group and 96.4% (108/112) in the TVT-O group. No significant difference was found between these two groups in the success rate by non-inferiority test (P < 0.0005), with significant improvement in quality of life and no significant difference in patient satisfaction rates in the two groups (P > 0.05). CONCLUSIONS: In the study, the TVT-O procedure could be defined to be identical to the TVT approach in success rate by non-inferiority test.
机译:介绍和假设:本研究旨在在疗效和安全性方面展示,无张力阴道胶带(TVT)和转基因仪阴道带内外(TVT-O)对压力尿失禁的程序。方法:将咳嗽应力测试应用于客观结果,而尿失禁特定的生命质量问卷应用于主观结果。进行对非劣效性的测试,用于检测两组之间的成功率。结果:在TVT集团中发现客观成功率为95.4%(62/65),在TVT-O集团中为96.4%(108/112)。在这两组之间的成功率之间没有显着差异(P <0.0005),在两组中具有显着改善,两组患者满意度没有显着差异(P> 0.05)。结论:在该研究中,可以定义TVT-O程序以非劣级度测试的成功率与TVT方法相同。

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