Tieu Aimee L, Hegde Aparna, Castillo Peter A, Davila G Willy, Aguilar Vivian C
Department of Gynecology, Urogynecology & Reconstructive Pelvic Surgery, Cleveland Clinic Florida, Weston, FL, USA.
, 8725 N. Wickham Rd #302, Melbourne, FL, 32940, USA.
Int Urogynecol J. 2017 Mar;28(3):461-467. doi: 10.1007/s00192-016-3128-z. Epub 2016 Oct 6.
To compare 1-year surgical outcomes following transobturator (TO) sling placement and single incision (SI) sling placement for the treatment of stress urinary incontinence (SUI).
We performed a randomized trial at a single institution. Patients with urodynamically proven SUI were offered participation and randomized to placement of a TO sling (Monarc™) or a SI sling (MiniArc™) between 2008 and 2011. The primary outcome measure was urinary leakage during standardized cough stress test (CST). Forty subjects in each group were required to achieve 80 % power to detect an effect size of 0.25.
A total of 98 patients were randomized with 49 patients in the TO group and 49 patients in the SI group. Preoperative demographics were similar between the groups (Table 1). The TO group had a significantly longer sling operative time (10.7 ± 4.8 min vs. 7.8 ± 4.9 min, p < 0.001) and greater estimated blood loss (31.6 ± 26.6 mL vs. 22.9 ± 22.1 mL, p = 0.02). At the 1-year follow-up, there was no difference in the primary outcome with 9 TO patients (21 %) and 12 SI patients (29 %) having a positive CST (p = 0.5). A composite measurement of 'failure', defined as patient-reported SUI and a positive CST, showed no difference between the TO group (17 %) and the SI group (27 %; p = 0.3).
The SI sling provides comparable objective efficacy to the TO sling at 1 year.
比较经闭孔（TO）吊带置入术和单切口（SI）吊带置入术治疗压力性尿失禁（SUI）的1年手术效果。
我们在单一机构进行了一项随机试验。对经尿动力学证实为SUI的患者进行招募，并在2008年至2011年期间将其随机分为接受TO吊带（Monarc™）置入术或SI吊带（MiniArc™）置入术。主要结局指标是标准化咳嗽压力测试（CST）期间的尿失禁情况。每组需要40名受试者以达到80%的检验效能来检测效应量为0.25的差异。
共有98例患者被随机分组，TO组49例，SI组49例。两组术前人口统计学特征相似（表1）。TO组吊带手术时间明显更长（10.7±4.8分钟对7.8±4.9分钟，p<0.001），估计失血量更多（31.6±26.6毫升对22.9±22.1毫升，p=0.02）。在1年随访时，主要结局无差异，TO组9例患者（21%）和SI组12例患者（29%）CST结果为阳性（p=0.5）。将患者报告的SUI和阳性CST定义为“失败”的综合测量结果显示，TO组（17%）和SI组（27%；p=0.3）之间无差异。
SI吊带在1年时提供了与TO吊带相当的客观疗效。
