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

Abstract

<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Findings</h4>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.<h4>Interpretation</h4>The risk of MUS removal or section was higher after TVT than TOT, with a time-varying effect, in this hypothetical target trial.<h4>Funding</h4>This study was funded by a grant from the French Ministry of Health.