Departamento Clínico, Universidad Europea de Madrid, Madrid.
Servicio de Urología, Hospital Universitario de Getafe, Madrid, Spain.
PLoS One. 2019 Dec 2;14(12):e0225762. doi: 10.1371/journal.pone.0225762. eCollection 2019.
Urinary incontinence is one of the most serious complications of prostate cancer treatment. The objective of this study was to assess efficacy and safety of Adjustable Transobturator Male System (ATOMS) compared to Adjustable Continence Therapy (proACT) for male stress urinary incotinence according to literature findings.
A systematic review and meta-analysis on adjustable devices ATOMS and ProACT is presented. Studies on female or neurogenic incontinence were excluded. Differences between ATOMS and proACT in primary objective: dryness status (no-pad or one safety pad/day) after initial device adjustment, and in secondary objectives: improvement, satisfaction, complications and device durability, were estimated using random-effect model. Statistical heterogeneity among studies included in the meta-analysis was assessed using tau2, Higgins´s I2 statistics and Cochran´s Q test.
Combined data of 41 observational studies with 3059 patients showed higher dryness (68 vs. 55%; p = .01) and improvement (91 vs. 80%; p = .007) rate for ATOMS than ProACT. Mean pad-count (-4 vs. -2.5 pads/day; p = .005) and pad-test decrease (-425.7 vs. -211.4 cc; p < .0001) were also significantly lower. Satisfaction was higher for ATOMS (87 vs. 56%; p = .002) and explant rate was higher for proACT (5 vs. 24%; p < .0001). Complication rate for ProACT was also higher, but not statistically significant (17 vs. 26%; p = .07). Mean follow-up was 25.7 months, lower for ATOMS than ProACT (20.8 vs. 30.6 months; p = .02). The rate of working devices favoured ATOMS at 1-year (92 vs. 76; p < .0001), 2-years (85 vs. 61%; p = .0008) and 3-years (81 vs. 58%; p = .0001). Significant heterogeneity was evidenced, due to variable incontinence severity baseline, difficulties for a common reporting of complications, different number of adjustments and time of follow-up and absence of randomized studies.
Despite the limitations that studies available are exclusively descriptive and the follow-up is limited, literature findings confirm ATOMS is more efficacious, with higher patient satisfaction and better durability than ProACT to treat male stress incontinence.
尿失禁是前列腺癌治疗后最严重的并发症之一。本研究的目的是根据文献评估可调经肛男性系统（ATOMS）与可调性持续治疗（proACT）治疗男性压力性尿失禁的疗效和安全性。
对可调装置 ATOMS 和 ProACT 进行了系统评价和荟萃分析。排除了女性或神经源性尿失禁的研究。使用随机效应模型估计初始设备调整后主要目标（无垫或每天一片安全垫）的干燥状态和次要目标（改善、满意度、并发症和设备耐用性）中 ATOMS 和 proACT 之间的差异。使用 tau2、Higgins 氏 I2 统计量和 Cochran 氏 Q 检验评估纳入荟萃分析的研究之间的统计异质性。
综合 41 项观察性研究的 3059 例患者的数据显示，ATOMS 的干燥率（68%比 55%；p=0.01）和改善率（91%比 80%；p=0.007）均高于 ProACT。平均垫计数（-4 比-2.5 垫/天；p=0.005）和垫试验减少（-425.7 比-211.4 cc；p<0.0001）也显著降低。ATOMS 的满意度更高（87%比 56%；p=0.002），而 proACT 的植入率更高（5%比 24%；p<0.0001）。ProACT 的并发症发生率也较高，但无统计学意义（17%比 26%；p=0.07）。平均随访时间为 25.7 个月，ATOMS 比 ProACT 短（20.8 比 30.6 个月；p=0.02）。1 年时工作设备的比例有利于 ATOMS（92%比 76%；p<0.0001），2 年时（85%比 61%；p=0.0008）和 3 年时（81%比 58%；p=0.0001）。由于基线失禁严重程度不同、并发症难以共同报告、调整次数和随访时间不同以及缺乏随机研究，证据表明存在显著的异质性。
尽管现有研究均为描述性研究，随访时间有限，但文献结果证实 ATOMS 比 proACT 更有效，患者满意度更高，耐用性更好，可治疗男性压力性尿失禁。
