Scheiner David A, Betschart Cornelia, Wiederkehr Sandra, Seifert Burkhardt, Fink Daniel, Perucchini Daniele
Department of Gynecology, University Hospital Zurich, Frauenklinikstrasse 10, 8091 Zurich, Switzerland.
Int Urogynecol J. 2012 Feb;23(2):197-206. doi: 10.1007/s00192-011-1543-8. Epub 2011 Sep 2.
The purpose of this study is to compare retropubic tension-free vaginal tape (TVT) with transobturator out-in TOT and in-out TVT-O for female stress urinary incontinence. Uroflow rate was primary; continence rates, quality of life (QoL) and complication pattern were secondary endpoints.
A prospective randomised trial with 2:1:1 randomisation at two Swiss teaching hospitals. Patients were followed up at 12 months.
Eighty TVT, 40 transobturator tape (TOT) and 40 TVT-O were randomised. At 12 months, there was no difference in Qmax among the groups. Continence was comparable (≥ 89%). QoL was improved significantly in all groups (P < 0.05). Five vaginal tape exposures occurred (one TVT, four TOT, zero TVT-O; P = 0.028). Two percent (1/52) of sexually active patients after TVT, 17% (5/29) after TOT, but 0% (0/25) after TVT-O reported de novo female sexual dysfunction (P = 0.011). We considered this clinically important enough to stop enrolment.
There was no difference for Qmax at 12 months between TVT, TOT and TVT-O. Female sexual dysfunction and tape exposure may be higher with a transobturator tape.
本研究旨在比较耻骨后无张力阴道吊带术（TVT）与经闭孔内外侧TOT以及内外侧TVT - O治疗女性压力性尿失禁的效果。尿流率为主要指标；控尿率、生活质量（QoL）和并发症类型为次要终点。
在两家瑞士教学医院进行一项前瞻性随机试验，随机比例为2:1:1。对患者进行12个月的随访。
随机分配了80例接受TVT、40例接受经闭孔吊带术（TOT）和40例接受TVT - O的患者。12个月时，各组间的最大尿流率（Qmax）无差异。控尿情况相当（≥89%）。所有组的生活质量均有显著改善（P < 0.05）。发生了5例阴道吊带暴露（1例TVT、4例TOT、0例TVT - O；P = 0.028）。接受TVT的性活跃患者中有2%（1/52）、接受TOT的患者中有17%（5/29）、但接受TVT - O的患者中无（0/25）报告出现新发女性性功能障碍（P = 0.011）。我们认为这在临床上具有足够的重要性，因此停止入组。
TVT、TOT和TVT - O在12个月时的Qmax无差异。经闭孔吊带术导致女性性功能障碍和吊带暴露的发生率可能更高。
