AI Article Synopsis
- The study aimed to compare the efficacy and safety of two surgical methods, TVT (tension-free vaginal tape) and TVT-Secur, for treating stress incontinence in women.
- Out of 280 women enrolled, 123 completed the trial, showing a 92% cure rate for TVT compared to 72% for TVT-Secur at the 2-month follow-up.
- The TVT-Secur group experienced three significant complications, while no major issues arose from the TVT group, leading researchers to recommend against the use of TVT-Secur going forward.
Article Abstract
Introduction And Hypothesis: The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety.
Methods: We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up.
Results: No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001).
Conclusions: In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.
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| http://dx.doi.org/10.1007/s00192-011-1381-8 | DOI Listing |
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