Service de Gynécologie-Obstétrique, CHI Poissy-St-Germain, Poissy, France.
Université Paris-Saclay, UVSQ, Unité de recherche 7285 "Risques cliniques et sécurité en santé des femmes et en santé périnatale" (RISCQ), Montigny-le-Bretonneux, Service de Gynécologie-Obstétrique, CHI Poissy-Saint-Germain, Poissy, France.
Am J Obstet Gynecol. 2024 Apr;230(4):428.e1-428.e13. doi: 10.1016/j.ajog.2023.11.1241. Epub 2023 Nov 25.
Midurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them.
This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence.
This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery.
A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8-7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9-4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3-0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0-3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7-4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence.
The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring.
经尿道中段吊带术是治疗压力性尿失禁的金标准，但它们的并发症可能令人担忧。并发症可能因放置吊带的方式而异。
本研究旨在比较女性压力性尿失禁患者经耻骨后入路和经闭孔入路行尿道中段吊带术的严重并发症和复发后的再次手术率。
本分析纳入了自 2017 年 2 月以来参加法国多中心 VIGI-MESH 注册的患者，这些患者因女性压力性尿失禁接受了尿道中段吊带术，分为经耻骨后入路和经闭孔入路，排除了单切口吊带患者。随访持续至 2021 年 10 月。使用 Cox 比例风险模型比较严重并发症（Clavien-Dindo 分级≥3 级）和复发后的再次手术，该模型包括任何相关手术（子宫切除术或脱垂）和脆弱性项，以考虑中心效应。使用倾向评分加权法平衡基线差异。使用倾向评分和 Cox 模型的分析调整了基线差异、中心效应和相关手术。
在 27 个法国中心，167 名外科医生共为 1830 名患者放置了耻骨后吊带，852 名患者放置了经闭孔吊带。经耻骨后入路组 2 年累积严重并发症估计发生率为 5.8%（95%置信区间，4.8-7.0），经闭孔入路组为 2.9%（95%置信区间，1.9-4.3），调整后，经耻骨后入路组有一半患者受影响（调整后的风险比，0.41；95%置信区间，0.3-0.6）。经耻骨后入路组 2 年累积因压力性尿失禁复发再次手术率为 2.7%（95%置信区间，2.0-3.6），经闭孔入路组为 2.8%（95%置信区间，1.7-4.2），调整后，经闭孔入路组再次手术的风险更高（调整后的风险比，1.9；95%置信区间，1.2-2.9）；但在排除既往压力性尿失禁手术的患者后，这种超额风险消失。
与耻骨后入路相比，经闭孔入路放置尿道中段吊带术严重并发症风险较低，但复发后再次手术风险较高。尽管涉及的外科医生数量众多，但这些风险较低。因此，数据令人安心。
