Madsen Annetta M, El-Nashar Sherif A, Woelk Joshua L, Klingele Christopher J, Gebhart John B, Trabuco Emanuel C
Division of Gynecologic Surgery, Mayo Clinic, Rochester, MN, USA.
Int Urogynecol J. 2014 Mar;25(3):351-8. doi: 10.1007/s00192-013-2208-6. Epub 2013 Sep 17.
Despite established comparable efficacy between retropubic midurethral (RMUS) and transobturator slings, there are conflicting data regarding single-incision mini-slings (SIMS). This study tests the null hypothesis that the MiniArc® Single-Incision Sling is equivalent to the ALIGN® Urethral Support System for treatment of stress urinary incontinence (SUI).
Women who underwent a sling for SUI from 1 January 2008 through 31 December 2009 were identified (N = 324). A follow-up survey was mailed. Primary outcomes were treatment failure, defined as International Consultation on Incontinence Questionnaire (ICIQ) score >0 or additional anti-incontinence procedure, and stress-specific incontinence (SSI). Secondary outcomes included Patient Global Impression of Severity and Improvement (PGI-SI), satisfaction, de novo urge, and complications.
The study included 202 women who returned the survey. The SIMS group had higher body mass index (BMI) (30.7 ± 6.5 vs 28.9 ± 6.0 kg/m(2), P = 0.052) and shorter follow-up (18.6 ± 11.5 vs 22.9 ± 14.6 months, P = 0.019). Treatment failure was higher in SIMS compared with RMUS (76.3 % vs 64.2 %) with adjusted odds ratio of 1.84 (95 % CI, 1.0, 3.5). The SIMS group was more likely to have postoperative SSI, with adjusted OR of 2.4 (95 % CI; 1.3-4.5). The RMUS group reported more improvement and satisfaction. Incidence of de novo urge and complications were similar between groups. Reoperation for mesh erosion was more likely in the RMUS group, while the SIMS had a higher reoperation rate for SUI.
Compared with retropubic ALIGN® Slings, MiniArc® Single-Incision Slings are less effective, with more postoperative incontinence, less patient-reported improvement, satisfaction, and higher reoperation rates for SUI.
尽管耻骨后中段尿道悬吊术（RMUS）和经闭孔吊带术之间已证实疗效相当，但关于单切口迷你吊带术（SIMS）的数据却相互矛盾。本研究检验了零假设，即MiniArc®单切口吊带与ALIGN®尿道支撑系统在治疗压力性尿失禁（SUI）方面等效。
确定了2008年1月1日至2009年12月31日期间因SUI接受吊带手术的女性（N = 324）。邮寄了一份随访调查问卷。主要结局为治疗失败，定义为国际尿失禁咨询问卷（ICIQ）评分>0或再次进行抗尿失禁手术，以及压力性特异性尿失禁（SSI）。次要结局包括患者总体严重程度和改善印象（PGI-SI）、满意度、新发尿急和并发症。
该研究纳入了202名回复调查问卷的女性。SIMS组的体重指数（BMI）较高（30.7±6.5 vs 28.9±6.0 kg/m²，P = 0.052）且随访时间较短（18.6±11.5 vs 22.9±14.6个月，P = 0.019）。与RMUS相比，SIMS的治疗失败率更高（76.3% vs 64.2%），调整后的优势比为1.84（95%CI，1.0，3.5）。SIMS组术后发生SSI的可能性更大，调整后的OR为2.4（95%CI；1.3 - 4.5）。RMUS组报告的改善和满意度更高。两组之间新发尿急和并发症的发生率相似。RMUS组因网片侵蚀进行再次手术的可能性更大，而SIMS因SUI进行再次手术的发生率更高。
与耻骨后ALIGN®吊带相比，MiniArc®单切口吊带效果较差，术后尿失禁更多，患者报告的改善和满意度更低，且因SUI进行再次手术的发生率更高。
