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澳大利亚北昆士兰的尿道下吊带成形术评估研究:悬吊试验

Suburethral slingplasty evaluation study in North Queensland, Australia: the SUSPEND trial.

作者信息

Lim Yik Nyok, Muller Reinhold, Corstiaans Audrey, Dietz Hans P, Barry Christopher, Rane Ajay

机构信息

James Cook University, Queensland, Australia.

出版信息

Aust N Z J Obstet Gynaecol. 2005 Feb;45(1):52-9. doi: 10.1111/j.1479-828X.2005.00356.x.

DOI:10.1111/j.1479-828X.2005.00356.x
PMID:15730366
Abstract

OBJECTIVE

To compare the safety and efficacy of three types of suburethral slings for the treatment of urodynamic stress incontinence.

METHODS

Following ethics approval, 195 (3 x 65) patients with urodynamic stress incontinence were randomly assigned to undergo suburethral slingplasty with the Tension-free Vaginal Tape (TVT; Gynecare, Ethicon, Somerville, NJ, USA), Intravaginal Sling (IVS; Tyco Healthcare, Mansfield, MA, USA), or Suprapubic Arc Sling (SPARC; American Medical Systems, Minnetonka, MN, USA). The patients were blinded to the type of sling implanted. MAIN OUTCOME MEASURES WERE: (1) operative and short-term complications; (2) pre- and postoperative symptomatology; and (3) pre- and postoperative urodynamic findings.

RESULTS

There was a statistically significant increased rate of sling protrusion (13.1% vs. 3.3% and 1.7%; P = 0.04) in the SPARC group when compared to TVT and IVS. Otherwise, there were no significant differences between the groups with respect to the incidences of other operative complications, patients' main subjective outcomes, satisfaction rates, or postoperative urodynamic findings. The overall objective stress incontinence cure rates were 87.9%, 81.5% and 72.4% for the TVT, IVS, SPARC groups respectively (P = 0.11).

CONCLUSIONS

All three slings appear quite successful for the treatment of stress incontinence. The SPARC tapes showed more sling protrusion complications and a trend towards lower objective cure rates; probably as a result of the insertion method used in this study which favoured a loose SPARC sling placement. The authors recommend that the SPARC slings be left tighter than TVT, or for the cough test to be carried out.

摘要

目的

比较三种类型的尿道下吊带治疗尿动力学压力性尿失禁的安全性和有效性。

方法

经伦理批准后,195例(3×65)尿动力学压力性尿失禁患者被随机分配接受无张力阴道吊带术(TVT;美国新泽西州索默维尔市Ethicon公司的吉妮柔适)、阴道内吊带术(IVS;美国马萨诸塞州曼斯菲尔德市泰科医疗公司)或耻骨上弧形吊带术(SPARC;美国明尼苏达州明尼通卡市美国医疗系统公司)。患者对所植入吊带的类型不知情。主要观察指标为:(1)手术及短期并发症;(2)术前和术后症状;(3)术前和术后尿动力学检查结果。

结果

与TVT组和IVS组相比,SPARC组吊带突出率在统计学上显著增加(13.1%对3.3%和1.7%;P = 0.04)。除此之外,在其他手术并发症发生率、患者主要主观结果、满意率或术后尿动力学检查结果方面,各组之间无显著差异。TVT组、IVS组、SPARC组的总体客观压力性尿失禁治愈率分别为87.9%、81.5%和72.4%(P = 0.11)。

结论

所有三种吊带治疗压力性尿失禁似乎都相当成功。SPARC吊带显示出更多的吊带突出并发症,且客观治愈率有降低趋势;这可能是由于本研究中使用的插入方法有利于放置较松的SPARC吊带。作者建议SPARC吊带应比TVT吊带系得更紧,或者进行咳嗽试验。

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