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一项多中心随机临床对照试验,比较耻骨后(RP)入路与经闭孔入路(TO)用于无张力尿道下吊带治疗尿动力学压力性尿失禁:TORP研究。

A multi-centre, randomised clinical control trial comparing the retropubic (RP) approach versus the transobturator approach (TO) for tension-free, suburethral sling treatment of urodynamic stress incontinence: the TORP study.

作者信息

Barry Christopher, Lim Yik Nyok, Muller Reinhold, Hitchins Sarah, Corstiaans Audrey, Foote Andrew, Greenland Hugh, Frazer Malcolm, Rane Ajay

机构信息

Obstetrics and Gynaecology, Queen Elizabeth Hospital, 28 Woodville Road, Adelaide, SA 5011, Australia.

出版信息

Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):171-8. doi: 10.1007/s00192-007-0412-y. Epub 2007 Jul 19.

Abstract

To compare the safety and efficacy of the transobturator tape (Monarc) with the retropubic tape (tension-free vaginal tape, TVTR) for the treatment of urodynamic stress incontinence (USI) a prospective, single-blinded, multi-centre randomised clinical controlled trial was undertaken in four urogynaecology units in Australia. One hundred and eighty-seven women with USI were randomly allocated to undergo surgery with either the Monarc sling (n = 80) or TVT (n = 107). Outcome measures were intra-operative complications (especially bladder injury), as well as peri-operative complications, symptomatology, quality of life and urodynamic outcomes. At 3 months, data were available on 140 women, 82 (59%) TVT and 58 (42%) Monarc. The TVT group was significantly more likely to be complicated by bladder injury (7 TVT, 0 Monarc, p < 0.05). Blood loss and operative time were significantly less in the Monarc group, which was 49 mls (31) vs that of the TVT group, which was 64 mls (41) p < 0.05; 18.5 min (6.5) TVT vs 14.6 min (6) Monarc (p < 0.001). The subjective and objective stress incontinence cure rates were 86.6% (71) vs 72.4% (42) p = 0.77 and 79.3 vs 84.5%, p = 0.51 for the TVT and Monarc groups, respectively. Both groups reported similar improvement in incontinence impact and satisfaction with their operation, although return to activity was significantly quicker with the transobturator route (p = 0.029). The transobturator tape appears to be as effective as the retro-pubic tape in the short term, with a reduction in the risk of intra-operative bladder injury, shorter operating time, decreased blood loss, and quicker return to usual activities.

摘要

为比较经闭孔吊带术(Monarc)与耻骨后吊带术(无张力阴道吊带术,TVTR)治疗尿动力学压力性尿失禁(USI)的安全性和有效性,在澳大利亚的四个泌尿妇科单位进行了一项前瞻性、单盲、多中心随机临床对照试验。187例USI女性被随机分配接受Monarc吊带术(n = 80)或经阴道无张力尿道中段吊带术(TVT,n = 107)。观察指标包括术中并发症(尤其是膀胱损伤)、围手术期并发症、症状、生活质量和尿动力学结果。3个月时,140例女性有数据,其中82例(59%)为TVT组,58例(42%)为Monarc组。TVT组膀胱损伤并发症显著更多(TVT组7例,Monarc组0例,p < 0.05)。Monarc组失血和手术时间显著更少,分别为49毫升(31),而TVT组为64毫升(41),p < 0.05;TVT组18.5分钟(6.5),Monarc组14.6分钟(6)(p < 0.001)。TVT组和Monarc组主观和客观压力性尿失禁治愈率分别为86.6%(71例)对72.4%(42例),p = 0.77;79.3%对84.5%,p = 0.51。两组报告失禁影响和手术满意度改善相似,尽管经闭孔途径恢复活动明显更快(p = 0.029)。经闭孔吊带术在短期内似乎与耻骨后吊带术一样有效,可降低术中膀胱损伤风险,并缩短手术时间、减少失血及更快恢复日常活动。

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