, Volume 23, Issue 1, pp 99-104

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

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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.


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.


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).


In the study, the TVT-O procedure could be defined to be identical to the TVT approach in success rate by non-inferiority test.

This study was conducted in the city of Shanghai, China.