Department of Women's Health, University of Texas at Austin, Dell Medical School, Austin, TX.
Department of Obstetrics and Gynecology, Scripps Clinic, San Diego, CA.
Am J Obstet Gynecol. 2020 Oct;223(4):545.e1-545.e11. doi: 10.1016/j.ajog.2020.03.008. Epub 2020 Mar 14.
Long-term safety and efficacy data on use of single-incision slings in stress urinary incontinence are limited.
To determine whether the single-incision sling Solyx (Boston Scientific, Marlborough, MA) is noninferior to the transobturator sling Obtryx II (Boston Scientific) in efficacy and safety for treatment of stress urinary incontinence. This 522 post-market surveillance study has been designed in response to a Food and Drug Administration request to evaluate improvement in stress urinary incontinence at 36 months following single-incision sling compared with baseline, as well as provide an assessment of mesh-related complications and subject-reported outcomes, relative to the transobturator sling control.
This prospective, nonrandomized, parallel cohort, multicenter postapproval study enrolled subjects to receive single-incision sling or transobturator sling. Study sites were assigned to a cohort group based on documented competency with the cohort device. Patient follow-up was 36 months to compare efficacy and adverse events for noninferiority. Inclusion criteria included stress predominant urinary incontinence, a positive cough stress test, and post-void residual ≤150 cc. Participants were ineligible if they had undergone previous stress urinary incontinence surgery or had a previous mesh complication. Primary endpoint was treatment success defined by composite negative cough stress test and subjective improvement in stress urinary incontinence using Patient Global Impression of Improvement at 36 months. Secondary endpoints included adverse events and indications for retreatment. Noninferiority margins of 15% and 10% were prespecified for the primary efficacy and safety endpoints. Data analysis was performed using intent-to-treat and per-protocol methods. Due to the observational nature of the study, a propensity score methodology was applied to account for differences in patient and surgeon characteristics between treatment groups. The study design and variables to be included in the propensity score model were reviewed and approved by Food and Drug Administration reviewers before outcome analyses were performed.
No evidence of imbalance in baseline characteristics was observed between groups after propensity score stratification in the 281 subjects. EBL (72.3±92 vs 73.1±63.9 mL, P=.786), time to spontaneous void (1.1±2 vs 0.8±2.8 days, P=.998), and time to discharge (0.7±0.7 vs 0.6±0.6 days, P=.524) were similar between groups. At 36 months, treatment success was 90.4% in the single-incision sling group and 88.9% in the transobturator sling group (P=.93). At 36 months, mesh-related complications were similar between groups (mesh exposure: 2.8% vs 5.0%, P=.38). Serious adverse events including pain during intercourse (0.7% vs 0%, P=1.00), pelvic pain (0.7% vs 0%, P=1.00), and urinary retention (2.8% vs 4.3%, P=.54) were similar between groups.
Single-incision sling was not inferior to transobturator sling for long-term treatment success of stress urinary incontinence. The rates of serious adverse events were acceptably low and similar between groups.
关于单切口吊带在治疗压力性尿失禁中的长期安全性和疗效数据有限。
确定单切口吊带 Solyx（波士顿科学公司，马萨诸塞州马尔伯勒）是否在疗效和安全性方面不劣于经闭孔吊带 Obtryx II（波士顿科学公司），用于治疗压力性尿失禁。这项 522 例上市后监测研究是应食品和药物管理局的要求设计的，旨在评估与基线相比，单切口吊带在 36 个月时治疗压力性尿失禁的改善情况，并评估与经闭孔吊带对照的与网片相关的并发症和受试者报告的结果。
这项前瞻性、非随机、平行队列、多中心上市后批准研究纳入了接受单切口吊带或经闭孔吊带治疗的患者。研究地点根据与队列装置相关的文件记录的能力被分配到一个队列组。患者随访时间为 36 个月，以比较非劣效性的疗效和不良事件。纳入标准包括以压力为主的尿失禁、咳嗽应激试验阳性和残余尿量≤150cc。如果患者先前接受过压力性尿失禁手术或有先前的网片并发症，则不符合入组条件。主要终点是在 36 个月时使用患者总体印象改善（Patient Global Impression of Improvement）来定义复合阴性咳嗽应激试验和压力性尿失禁主观改善的治疗成功。次要终点包括不良事件和再次治疗的指征。主要疗效和安全性终点的非劣效性边界分别设定为 15%和 10%。使用意向治疗和方案治疗方法进行数据分析。由于研究的观察性质，应用倾向评分方法来解释治疗组之间的患者和外科医生特征差异。在进行结果分析之前，研究设计和要包含在倾向评分模型中的变量已由食品和药物管理局审查员审查和批准。
在 281 名接受倾向评分分层的患者中，未观察到组间基线特征存在不平衡。EBL（72.3±92 与 73.1±63.9ml，P=.786）、自发排尿时间（1.1±2 与 0.8±2.8 天，P=.998）和出院时间（0.7±0.7 与 0.6±0.6 天，P=.524）在组间相似。在 36 个月时，单切口吊带组的治疗成功率为 90.4%，经闭孔吊带组为 88.9%（P=.93）。在 36 个月时，两组间网片相关并发症相似（网片暴露：2.8%与 5.0%，P=.38）。两组间相似的严重不良事件包括性交时疼痛（0.7%与 0%，P=1.00）、盆腔疼痛（0.7%与 0%，P=1.00）和尿潴留（2.8%与 4.3%，P=.54）。
单切口吊带在治疗压力性尿失禁的长期疗效方面并不劣于经闭孔吊带。严重不良事件的发生率较低且组间相似。
