Angulo Javier C, Téllez Carlos, Giammò Alessandro, González-Enguita Carmen, Schoenburg Sandra, Queissert Fabian, Szczesniewski Juliusz, González Raquel, Romero Antonio, Gonsior Andreas, Martins Francisco E, Antunes-Lopes Tiago, Cruz Francisco, Rourke Keith
Clinical Department, Faculty of Biomedical Science, Universidad Europea, Carretera de Toledo, Km 12.500, Getafe, 28905 Madrid, Spain.
Department of Urology, Hospital Universitario de Getafe, Carretera de Toledo, Km 12.500, Getafe, 28905 Madrid, Spain.
J Clin Med. 2023 Jul 17;12(14):4721. doi: 10.3390/jcm12144721.
(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, = 20; grade II, = 11; grade III, = 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 ( = 0.06), primary prostatectomy ( = 0.08), no previous incontinence surgery ( = 0.02), absence of overactive bladder symptoms ( = 0.04), absence of bladder neck stricture ( = 0.001), no need of surgical revision ( = 0.008) and lower baseline incontinence severity ( = 0.0003). Multivariate analysis identified absence of surgical revision ( = 0.018), absence of bladder neck stricture ( = 0.05), primary prostatectomy ( = 0.07) and lower baseline incontinence severity ( < 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.
（1）背景：对于接受根治性前列腺切除术及辅助盆腔放疗的前列腺癌患者，男性压力性尿失禁的治疗是一项治疗挑战。尽管人们普遍认为此类患者的治疗效果比未接受放疗的患者差，但可调节经闭孔男性系统（ATOMS）在这些患者中的疗效和安全性尚未明确确立。（2）方法：一项回顾性多中心研究，评估2016年至2022年间在9个不同机构接受根治性前列腺切除术及放疗后植入硅胶覆盖阴囊端口（SSP）ATOMS的患者。主要终点为患者干爽率，定义为尿垫试验≤20毫升/天。次要终点为并发症发生率（使用Clavien-Dindo分类法定义）、装置移除情况以及使用患者总体改善印象（PGI-I）量表的自我感知满意度。采用逐步法进行Wilcoxon秩和检验、Fisher精确检验及逻辑回归分析，纳入标准为0.15，留存标准为0.1。（3）结果：223例患者符合纳入标准，12例（5.4%）在放疗后接受了挽救性前列腺切除术，27例（12.1%）曾使用过治疗压力性尿失禁的装置。ATOMS调整后，95例（42.6%）患者达到干爽，36例（16.1%）在术后前3个月出现任何级别的并发症（I级，=20；II级，=11；III级，=5）。平均随访36±21个月时，26例（11.7%）患者的装置被取出。关于对植入物的自我感知满意度，125例患者中的105例（84%）认为自己满意（PGI-I为1至3）。单因素分析中，干爽与年龄较轻（=0.06）、初次前列腺切除术（=0.08）、既往无尿失禁手术（=0.02）、无膀胱过度活动症状（=0.04）、无膀胱颈狭窄（=0.001）、无需手术修复（=0.008）以及较低的基线尿失禁严重程度（=0.0003）相关。多因素分析确定无需手术修复（=0.018）、无膀胱颈狭窄（=0.05）、初次前列腺切除术（=0.07）以及较低的基线尿失禁严重程度（<0.0001）是干爽的独立预测因素。提出并内部验证了一个逻辑回归模型。（4）结论：ATOMS是根治性前列腺切除术及辅助放疗后治疗男性尿失禁的一种有效且安全的选择。在这一复杂情况下确定了干爽的预测因素，以便更好地进行患者选择。
