Abstract
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.
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Acknowledgments
This study was supported by the National Natural Science Foundation of China (no. 30471815). The authors wish to express appreciation to Yongfeng Zhao, Junhua Liang, Xia Jin, and Lei Chu for their efforts in data collection and to Bozhen Fan, Li Li, and Jianjun Wang for their constant support.
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This study was conducted in the city of Shanghai, China.
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Yang, X., Jiang, M., Chen, X. et al. TVT-O vs. TVT for the treatment of SUI: a non-inferiority study. Int Urogynecol J 23, 99–104 (2012). https://doi.org/10.1007/s00192-011-1537-6
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DOI: https://doi.org/10.1007/s00192-011-1537-6