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女性复发性压力性尿失禁的手术治疗:随机对照试验的系统评价和荟萃分析。

Surgical treatment of recurrent stress urinary incontinence in women: a systematic review and meta-analysis of randomised controlled trials.

机构信息

NHS Ayrshire & Arran, NHS Research Scotland, Kilmarnock, UK.

出版信息

Eur Urol. 2013 Aug;64(2):323-36. doi: 10.1016/j.eururo.2013.04.034. Epub 2013 Apr 26.

DOI:10.1016/j.eururo.2013.04.034
PMID:23680414
Abstract

CONTEXT

Recurrent stress urinary incontinence (R-SUI) represents a management dilemma; however, only a limited number of randomised controlled trials (RCTs) have assessed the various surgical procedures used for its treatment.

OBJECTIVE

To assess the effectiveness and complications of various surgical procedures for the treatment of female R-SUI.

EVIDENCE ACQUISITION

A prospective peer-reviewed protocol was prepared a priori. A systematic literature review of all published RCTs comparing surgical procedures for treatment of R-SUI was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. Data were analysed using RevMan 5.

EVIDENCE SYNTHESIS

We conducted a literature search from 1945 to February 2013. Data were available for a total of 350 women in 10 RCTs with a mean follow-up of 18.1 mo. Meta-analysis was possible for the comparison of retropubic tension-free vaginal tape (RP-TVT) versus transobturator tension-free vaginal tape (TO-TVT) in five RCTs (n = 135). There was no statistically significant difference between RP-TVT and TO-TVT in the patient-reported improvement (odds ratio [OR]: 0.84, 95% confidence interval [CI], 0.41-1.69) or objective cure/improvement (OR: 1.75; 95% CI, 0.86-3.54). One RCT showed a trend towards a higher rate of patient-reported and objective cure/improvement with the inside-out TO-TVT compared with the outside-in; however, it was not statistically significant (OR: 3.00; 95% CI, 0.85-10.57, and OR: 3.32; 95% CI, 0.96-11.41, respectively). There was no significant difference between Burch colposuspension and RP-TVT (one RCT) in patient-reported improvement (OR: 0.33; 95% CI, 0.01-8.57) or objective cure/improvement (OR: 0.52; 95% CI, 0.13-2.05).

CONCLUSIONS

This meta-analysis shows no evidence of a significant difference in patient-reported and objective cure/improvement rates between RP-TVT and TO-TVT in the surgical treatment of women with R-SUI. However, due to the relatively low number of patients, the analysis might be underpowered. This review highlights the poor level of evidence in this field and the need for well-designed clinical trials to address this important clinical dilemma.

摘要

背景

复发性压力性尿失禁(R-SUI)是一种治疗困境;然而,仅有少数随机对照试验(RCT)评估了用于治疗 R-SUI 的各种手术方法。

目的

评估治疗女性 R-SUI 的各种手术方法的有效性和并发症。

证据获取

预先制定了前瞻性同行评审方案。根据系统评价和荟萃分析报告的首选报告项目,对比较 R-SUI 治疗的各种手术方法的所有已发表 RCT 进行了系统文献检索。使用 RevMan 5 分析数据。

证据综合

我们从 1945 年至 2013 年 2 月进行了文献检索。共有 10 项 RCT 中的 350 名女性的数据可用于分析,平均随访时间为 18.1 个月。对 5 项 RCT 中经耻骨后无张力阴道吊带术(RP-TVT)与经闭孔无张力阴道吊带术(TO-TVT)的比较进行了荟萃分析(n = 135)。RP-TVT 与 TO-TVT 在患者报告的改善(比值比 [OR]:0.84,95%置信区间 [CI],0.41-1.69)或客观治愈率/改善(OR:1.75;95% CI,0.86-3.54)方面无统计学差异。一项 RCT 显示,与经皮入路相比,经皮入路 TO-TVT 的患者报告和客观治愈率/改善率有较高趋势,但无统计学意义(OR:3.00;95% CI,0.85-10.57 和 OR:3.32;95% CI,0.96-11.41)。Burch 阴道悬吊术与 RP-TVT(一项 RCT)在患者报告的改善(OR:0.33;95% CI,0.01-8.57)或客观治愈率/改善(OR:0.52;95% CI,0.13-2.05)方面无显著差异。

结论

本荟萃分析显示,在治疗 R-SUI 的女性患者中,RP-TVT 与 TO-TVT 在患者报告和客观治愈率/改善率方面无显著差异。然而,由于患者数量相对较少,分析可能没有足够的效力。该综述突出了该领域证据水平较差的问题,并需要精心设计的临床试验来解决这一重要的临床困境。

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