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Abstract：
(1) Background: Treatment of male stress incontinence in patients with prostate cancer treated with radical prostatectomy and adjuvant pelvic radiation is a therapeutic challenge. The efficacy and safety of the adjustable trans-obturator male system (ATOMS) in these patients is not well established, despite the general belief that outcomes are worse than in patients without radiation. (2) Methods: Retrospective multicenter study evaluating patients treated with silicone-covered scrotal port (SSP) ATOMS implant after radical prostatectomy and radiotherapy in nine different institutions between 2016 and 2022. The primary endpoint was dry patient rate, defined as pad-test ≤ 20 mL/day. The secondary endpoints were complication rate (defined using Clavien-Dindo classification), device removal and self-perceived satisfaction using the Patient Global Impression of Improvement (PGI-I) scale. Wilcoxon rank-sum test, Fisher\'s exact test and logistic regression were performed using stepwise method with a 0.15 entry and 0.1 stay criteria. (3) Results: 223 patients fulfilled the criteria for inclusion and 12 (5.4%) received salvage prostatectomy after radiation and 27 (12.1%) previous devices for stress incontinence. After ATOMS adjustment, 95 patients (42.6%) were dry and 36 (16.1%) had complications of any grade (grade I, n = 20; grade II, n = 11; grade III, n = 5) during the first 3 months postoperatively. At a mean of 36 ± 21 months follow-up, the device was explanted in 26 (11.7%) patients. Regarding self-perceived satisfaction with the implant, 105 of 125 patients (84%) considered themselves satisfied (PGI-I 1 to 3). In the univariate analysis, dryness was associated to younger age (p = 0.06), primary prostatectomy (p = 0.08), no previous incontinence surgery (p = 0.02), absence of overactive bladder symptoms (p = 0.04), absence of bladder neck stricture (p = 0.001), no need of surgical revision (p = 0.008) and lower baseline incontinence severity (p = 0.0003). Multivariate analysis identified absence of surgical revision (p = 0.018), absence of bladder neck stricture (p = 0.05), primary prostatectomy (p = 0.07) and lower baseline incontinence severity (p < 0.0001) were independent predictors of dryness. A logistic regression model was proposed and internally validated. (4) Conclusions: ATOMS is an efficacious and safe alternative to treat male incontinence after radical prostatectomy and adjuvant radiotherapy. Factors predictive of dryness are identified in this complex scenario to allow for better patient selection.
摘要：
（1）背景：前列腺癌根治术和盆腔辅助放疗治疗男性压力性尿失禁是一项治疗挑战。可调节的经闭孔男性系统（ATOMS）在这些患者中的疗效和安全性尚未得到很好的确立，尽管人们普遍认为结果比没有放疗的患者差。（2）方法：回顾性多中心研究评估2016年至2022年期间在9个不同机构进行根治性前列腺切除术和放疗后接受硅胶覆盖阴囊孔（SSP）ATOMS植入物治疗的患者。主要终点是干燥患者率，定义为垫试验≤20毫升/天。次要终点是并发症发生率（使用Clavien-Dindo分类定义），使用患者总体改善印象（PGI-I）量表进行设备移除和自我感知满意度。Wilcoxon秩和检验,使用逐步方法进行Fisher精确检验和逻辑回归，标准为0.15和0.1。（3）结果：223例患者符合入选标准，12例（5.4％）在放疗后接受了挽救性前列腺切除术，27例（12.1％）以前的压力性尿失禁装置。ATOMS调整后,95例（42.6％）患者为干性，36例（16.1％）有任何级别的并发症（I级，n=20；二级，n=11；三级，术后前3个月n=5）。平均随访36±21个月，26例(11.7%)患者植入该装置.关于自我感知对植入物的满意度，125例患者中有105例（84%）认为自己满意（PGI-I1至3）。在单变量分析中，干燥与年龄较小有关（p=0.06），原发性前列腺切除术（p=0.08），以前没有尿失禁手术（p=0.02），无膀胱过度活动症状（p=0.04），无膀胱颈狭窄（p=0.001），无需手术翻修(p=0.008),基线失禁严重程度降低(p=0.0003).多变量分析确定没有手术翻修(p=0.018)，无膀胱颈狭窄（p=0.05），原发性前列腺切除术(p=0.07)和基线失禁严重程度较低(p<0.0001)是干燥的独立预测因素.提出了逻辑回归模型并进行了内部验证。（4）结论：ATOMS是治疗前列腺癌根治术和辅助放疗后男性尿失禁的有效和安全的替代方法。在这种复杂的情况下，确定了预测干燥的因素，以便更好地选择患者。
