Department of Surgery, Division of Urology, Hospital Center of University of Sherbrooke, Sherbrooke, Canada.
Department of Gynecology, Urological Research Network LLC, Nova Southeastern University, Hialeah, Florida, USA.
Neurourol Urodyn. 2023 Nov;42(8):1722-1732. doi: 10.1002/nau.25256. Epub 2023 Aug 9.
To assess noninferiority of the safety and effectiveness of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic slings through 36 months in a prospective, longitudinal, nonrandomized US Food and Drug Administration (FDA) 522 cohort study.
Adult females with confirmed predominant stress urinary incontinence (UI) through cough stress test (CST) or urodynamics and failed two noninvasive incontinence therapies. Effectiveness endpoints included objective dryness, negative CST, adverse events, and revision/resurgery through 36 months. The primary effectiveness endpoint was reduction from baseline in 24-h pad weight of ≥50% at 6 months, as requested by the FDA, and is included as a study point in this paper. Primary safety endpoint was rate of related serious adverse events (SAE) through 36 months. Noninferiority margins of 15% and 10% were prespecified for the effectiveness and safety endpoints. Due to the observational nature of the cohort study, a propensity methodology was conducted to assess the effect of potential confounding variables on the primary endpoints between groups.
Three hundred fifty-five women underwent the sling procedure (n = 184 Altis; n = 171 Comparator). One hundred fourty (76%) Altis subjects and 101 (59%) Comparator subjects completed follow-up through 36 months. At 36 months, for the effectiveness endpoint, the difference in proportions of -0.005 for Altis versus Comparator (95% confidence interval [CI]: -0.102 to 0.092) was statistically significant (p = 0.002), supporting the hypothesis that Altis is noninferior to Comparator. Furthermore, both groups demonstrated high objective efficacy; in the Altis arm n = 99 (81.8%) subjects were a success, and in the Comparator arm, n = 79 (82.3%) subjects were a success. Additionally, regarding the CST, Altis was found to be noninferior to the Comparator at every study visit, and the rate of negative CST remained above 80% for both groups (p < 0.001). At 36 months, Altis (n = 2; 1.1%) and Comparator (n = 4; 2.3%) subjects experienced a device and/or procedure-related SAE. The difference in proportions of 0.013 for Altis versus Comparator (95% CI: -0.023 to 0.048) was statistically significant (p < 0.001), demonstrating that Altis is noninferior to Comparator with respect to the primary safety endpoint throughout the study. There were 62 (36.3%) retropubic midurethral slings (RMUS), 96 (56.1%) transobturator midurethral slings (TMUS), and 13 (7.6%) SIS slings in the Comparator group. For the 36 month effectiveness endpoint, assessing the noninferiority of Altis versus RMUS and Altis versus TMUS, 99 (81.8%) Altis and 37 (90.2%) RMUS were a success, trending toward statistical significance, however, it cannot be determined to be noninferior (p = 0.092). Ninty-nine (81.8%) Altis and 33 (71.7%) TMUS were a success; this was statistically significant (p < 0.001), demonstrating Altis was noninferior to TMUS. Rates of negative CST were 122 (87.1%) Altis, 40 (93.0%) RMUS (p < 0.001), and 44 (91.7%) TMUS (p < 0.001). CST demonstrated that Altis was noninferior to RMUS and Altis was noninferior to TMUS at 36 months.
Altis single-incision sling was noninferior to standard midurethral sling for treatment of stress UI, throughout the study and at 36 months. Furthermore, adverse event rates were low.
通过前瞻性、纵向、非随机美国食品和药物管理局（FDA）522 队列研究，评估 Altis®单切口吊带（SIS）与标准中尿道经闭孔和/或耻骨后吊带在 36 个月时的安全性和有效性的非劣效性。
通过咳嗽应激试验（CST）或尿动力学检查确认患有明显压力性尿失禁（UI）的成年女性，并经两种非侵入性失禁治疗失败。有效性终点包括客观干燥、CST 阴性、不良事件和 36 个月时的修订/再手术。主要有效性终点是根据 FDA 的要求，在 6 个月时 24 小时垫重减轻≥50%，该研究点也包含在本文中。主要安全性终点是 36 个月时与相关严重不良事件（SAE）的发生率。为有效性和安全性终点预先设定了 15%和 10%的非劣效性边界。由于队列研究的观察性质，采用倾向评分方法评估潜在混杂变量对主要终点的影响。
355 名女性接受了吊带手术（n=184 名 Altis；n=171 名对照）。140 名（76%）Altis 受试者和 101 名（59%）对照受试者完成了 36 个月的随访。在 36 个月时，有效性终点的结果显示，Altis 与对照的差异比例为-0.005（95%置信区间：-0.102 至 0.092），具有统计学意义（p=0.002），支持 Altis 不劣于对照的假设。此外，两组均表现出高的客观疗效；在 Altis 组，n=99（81.8%）的受试者为成功，在对照组，n=79（82.3%）的受试者为成功。此外，关于 CST，Altis 在每次研究访视时均被证明不劣于对照，并且两组的 CST 阴性率均保持在 80%以上（p<0.001）。在 36 个月时，Altis（n=2；1.1%）和对照（n=4；2.3%）受试者经历了与器械和/或程序相关的 SAE。Altis 与对照的差异比例为 0.013（95%置信区间：-0.023 至 0.048），具有统计学意义（p<0.001），表明 Altis 在整个研究期间与对照相比在主要安全性终点上不劣效。对照组中有 62 例（36.3%）耻骨后中尿道吊带（RMUS）、96 例（56.1%）经闭孔中尿道吊带（TMUS）和 13 例（7.6%）SIS 吊带。对于 36 个月的有效性终点，评估 Altis 与 RMUS 和 Altis 与 TMUS 的非劣效性，99 名（81.8%）Altis 和 37 名（90.2%）RMUS 为成功，具有统计学意义趋势，但不能确定为非劣效（p=0.092）。99 名（81.8%）Altis 和 33 名（71.7%）TMUS 为成功，具有统计学意义（p<0.001），表明 Altis 不劣效于 TMUS。CST 阴性率分别为 122 名（87.1%）Altis、40 名（93.0%）RMUS（p<0.001）和 44 名（91.7%）TMUS（p<0.001）。CST 表明 Altis 在 36 个月时不劣效于 RMUS，且不劣效于 TMUS。
Altis 单切口吊带在治疗压力性尿失禁方面不劣于标准中尿道吊带，在整个研究和 36 个月时均如此。此外，不良事件发生率较低。
