Departments of Reproductive Medicine and Gynecology and Anesthesiology, University Medical Center Utrecht, Utrecht, and Obstetrics and Gynecology, Reinier de Graaf, Delft, Isala, Zwolle, Amphia, Breda, and Groene Hart Hospital, Gouda, The Netherlands.
Obstet Gynecol. 2015 Jan;125(1):27-34. doi: 10.1097/AOG.0000000000000604.
To compare postoperative pain scores and assess efficacy between an adjustable single-incision sling and a standard transobturator sling for stress urinary incontinence (SUI).
This single-blinded randomized controlled trial involved 156 women with clinically proven SUI. Women were allocated to receive either an adjustable single-incision or a transobturator sling. The primary outcome was postoperative pain score on a visual analog scale. Secondary outcomes were objective and subjective cure rates at 12 months, symptom bother scores, quality of life, and complications.
The mean pain score in the first week postoperatively was significantly lower at all time points in the adjustable single-incision sling group compared with the transobturator sling group. Maximum difference in pain score was reported on the evening of the day of surgery; median pain score was 1.0 (interquartile range 2.0) in the adjustable sling group and 3.0 (interquartile range 4.5) in the transobturator sling group (Mann Whitney U test P<.001). There was no statistical difference in analgesic use. The objective cure rates in the adjustable single-incision sling and in the transobturator sling group were 90.8% and 88.6% (P=.760), and the subjective cure rates were 77.2% and 72.9% (P=.577), respectively. No difference in the complication rate was found.
An adjustable single-incision sling for the treatment of SUI is associated with lower early postoperative pain scores but shows comparable cure rates with a transobturator at 12 months of follow-up.
Netherlands Trial Register, http://www.trialregister.nl, NTR: 2558.
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比较可调节单切口吊带术与标准经闭孔吊带术治疗压力性尿失禁（SUI）的术后疼痛评分和疗效。
本单盲随机对照试验纳入了 156 例经临床证实患有 SUI 的女性。将女性患者分配接受可调节单切口吊带术或经闭孔吊带术。主要结局是术后视觉模拟评分法（VAS）的疼痛评分。次要结局是 12 个月时的客观和主观治愈率、症状困扰评分、生活质量和并发症。
与经闭孔吊带组相比，可调节单切口吊带组在术后第一周的所有时间点的疼痛评分均显著降低。在手术当天晚上，疼痛评分的最大差异最大；可调节吊带组的中位疼痛评分为 1.0（四分位距 2.0），经闭孔吊带组为 3.0（四分位距 4.5）（Mann-Whitney U 检验，P<.001）。两组在使用镇痛药方面无统计学差异。可调节单切口吊带组和经闭孔吊带组的客观治愈率分别为 90.8%和 88.6%（P=.760），主观治愈率分别为 77.2%和 72.9%（P=.577）。两组并发症发生率无差异。
可调节单切口吊带术治疗 SUI 与早期术后疼痛评分较低相关，但在 12 个月随访时与经闭孔吊带术相比，治愈率相当。
荷兰临床试验注册处，http://www.trialregister.nl，NTR：2558。
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