Long-term safety of mid-urethral sling for stress urinary incontinence in women: an emulated trial using French national health data system.

IF 10 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

EClinicalMedicine Pub Date : 2025-09-15 eCollection Date: 2025-09-01 DOI:10.1016/j.eclinm.2025.103411

Cyrille Guillot-Tantay, Sylvie Guillo, Minh Hoang Thuy Diep Tran, Yann de Rycke, Agnès Dechartres, Pierre Mozer, Emmanuel Chartier-Kastler, Florence Tubach

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引用次数: 0

Abstract

Background: Mid-urethral sling (MUS) is the most-indicated therapy for treating stress urinary incontinence (SUI) in women. However, serious long-term side effects have escaped post-marketing studies. We aimed to compare two different MUS types, tension-free vaginal tape (TVT) and trans-obturator tape (TOT), in terms of incidence of MUS removal or section after implantation.

Methods: We emulated a hypothetical target trial using French national healthcare data (SNDS) and included women who had undergone a first MUS implantation from 2011 to 2018 (Health Data Hub registration no. T16166982020061). The primary outcome was the cumulative incidence of MUS removal or section. Secondary outcomes were the cumulative incidence of MUS removal and section, hospitalization for urinary retention and MUS erosion and infection, and any of these outcomes, as well as reoperation for SUI. We used propensity score-weighted Cox models.

Findings: In all, 215,141 women underwent implantation: 170,781 (79.4%) with TOT and 44,360 (20.6%) with TVT. At 5 years, the weighted cumulative incidence of MUS removal or section was lower in the TOT than TVT group (3.25%, 95% confidence interval CI 3.16-3.34 versus 4.13%, 95% CI 3.94-4.33). We observed a time-varying effect ([0-3 months] after implantation [hazard ratio 1.65, 95% CI 1.52-1.78], [3-12 months] after implantation [1.19, 95% CI 1.06-1.32], [1-5 years] after implantation [0.98, 95% CI 0.88-1.1] and ≥5 years after implantation [1.44, 95% CI 1.13-1.85]). MUS removal and section and hospitalization for urinary retention and MUS erosion and infection were significantly more frequent in women with TVT than TOT but second MUS implantation for SUI recurrence was less frequent.

Interpretation: The risk of MUS removal or section was higher after TVT than TOT, with a time-varying effect, in this hypothetical target trial.

Funding: This study was funded by a grant from the French Ministry of Health.

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中尿道吊带治疗女性压力性尿失禁的长期安全性：使用法国国家卫生数据系统的模拟试验。

背景：尿道中悬吊（MUS）是治疗女性压力性尿失禁（SUI）最适合的治疗方法。然而，严重的长期副作用并没有在上市后进行研究。我们的目的是比较两种不同的MUS类型，无张力阴道带（TVT）和经闭孔带（TOT），在MUS植入后移除或切除的发生率。方法：我们使用法国国家卫生保健数据（SNDS）模拟了一项假设的目标试验，并纳入了2011年至2018年首次接受MUS植入的妇女(健康数据中心注册号：T16166982020061)。主要结果是MUS切除或切除的累积发生率。次要结果是MUS切除和切除的累积发生率，尿潴留和MUS糜烂和感染住院，以及任何这些结果，以及SUI的再手术。我们使用倾向评分加权Cox模型。结果：总共有215,141名妇女接受了植入：170,781名（79.4%）为TOT， 44,360名（20.6%）为TVT。在5年，TOT组的MUS切除或切片的加权累积发生率低于TVT组（3.25%，95%可信区间CI 3.16-3.34 vs 4.13%, 95% CI 3.94-4.33）。我们观察到时变效应（植入后[0-3个月][危险比1.65,95% CI 1.52-1.78]，植入后[3-12个月][1.19,95% CI 1.06-1.32]，植入后[1-5年][0.98,95% CI 0.88-1.1]和植入后≥5年][1.44,95% CI 1.13-1.85]）。TVT患者因尿潴留、MUS糜烂和感染而切除、切除和住院的频率明显高于TOT患者，但因SUI复发而再次植入MUS的频率较低。解释：在这个假设的目标试验中，TVT后MUS切除或切除的风险高于TOT，并且具有时变效应。经费：本研究由法国卫生部拨款资助。

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来源期刊

EClinicalMedicine Medicine-Medicine (all)

CiteScore

18.90

自引率

1.30%

发文量

506

审稿时长

22 days

期刊介绍： eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.