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合成尿道中段吊带植入术治疗成年女性压力性尿失禁的长期安全性:一项系统评价

Long-term Safety of Synthetic Midurethral Sling Implantation for the Treatment of Stress Urinary Incontinence in Adult Women: A Systematic Review.

作者信息

Guillot-Tantay Cyrille, Van Kerrebroeck Philippe, Chartier-Kastler Emmanuel, Dechartres Agnès, Tubach Florence

机构信息

Hôpital Foch, Service d'Urologie, Suresnes, France.

Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.

出版信息

Eur Urol Open Sci. 2023 Jun 10;54:10-19. doi: 10.1016/j.euros.2023.05.013. eCollection 2023 Aug.

DOI:10.1016/j.euros.2023.05.013
PMID:37334402
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10276216/
Abstract

CONTEXT

Midurethral slings (MUSs) are the most used therapy for the treatment of stress urinary incontinence (SUI). While warning signals about potential complications have been raised worldwide, there is a lack of safety data especially in the long term.

OBJECTIVE

Our objective was to evaluate synthetic MUS safety outcomes at long term in adult women.

EVIDENCE ACQUISITION

We included all studies evaluating MUSs in adult women with SUI. All synthetic MUSs have been considered: tension-free vaginal tape (TVT), transobturator tape (TOT), and mini-slings. The primary outcome was the reoperation rate at 5 yr.

EVIDENCE SYNTHESIS

Of 5586 references screened after duplicate removal, 44 studies (8218 patients) were included. Among these, nine were randomized controlled trials and 35 were cohort studies. The overall reoperation rates at 5 yr varied between 0% and 19% for TOT (11 studies), 0% and 13% for TVT (17 studies), and 0% and 19% for mini-slings (two studies). The overall reoperation rates at 10 yr varied between 5% and 15% for TOT (four studies) and between 2% and 17% for TVT (four studies). There were few safety data beyond 5 yr: 22.7% of the articles reported a follow-up at ≥10 yr and 2.3% at ≥15 yr.

CONCLUSIONS

The incidence rates of reoperations and complications are heterogeneous, and data beyond 5 yr are rare.

PATIENT SUMMARY

There is an urgent need to improve safety monitoring of mesh as our review highlights that available safety data are heterogeneous and of insufficient quality to guide the decision.

摘要

背景

中段尿道吊带术(MUSs)是治疗压力性尿失禁(SUI)最常用的疗法。尽管全球已发出有关潜在并发症的警示信号,但尤其是长期安全性数据仍很缺乏。

目的

我们的目的是评估成年女性长期使用合成MUS的安全性结果。

证据收集

我们纳入了所有评估成年SUI女性使用MUS的研究。所有合成MUS均在考虑范围内:无张力阴道吊带术(TVT)、经闭孔吊带术(TOT)和迷你吊带术。主要结局是5年时的再次手术率。

证据综合

在去除重复文献后筛选的5586篇参考文献中,纳入了44项研究(8218例患者)。其中,9项为随机对照试验,35项为队列研究。TOT(11项研究)5年时的总体再次手术率在0%至19%之间,TVT(17项研究)为0%至13%,迷你吊带术(2项研究)为0%至19%。TOT(4项研究)10年时的总体再次手术率在5%至15%之间,TVT(4项研究)为2%至17%。5年后的安全性数据很少:22.7%的文章报告随访时间≥10年,2.3%报告随访时间≥15年。

结论

再次手术和并发症的发生率存在异质性,5年后的数据很少。

患者总结

迫切需要改善网片的安全性监测,因为我们的综述强调现有安全性数据存在异质性且质量不足以指导决策。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0148/10276216/77fa47edcc6a/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0148/10276216/b92389c27af8/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0148/10276216/dd33df07bf1c/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0148/10276216/77fa47edcc6a/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0148/10276216/b92389c27af8/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0148/10276216/dd33df07bf1c/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0148/10276216/77fa47edcc6a/gr3.jpg

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