Department of Urology, Hospital Universitario de Getafe, Getafe, Madrid, Spain.
Department of Medical Clinic, Faculty of Biomedical Sciences, Universidad Europea de Madrid, Madrid, Spain.
Adv Ther. 2021 Jan;38(1):678-690. doi: 10.1007/s12325-020-01563-z. Epub 2020 Nov 23.
A prospective evaluation of outcomes in a series of patients with post-prostatectomy incontinence (PPI) treated with two different devices is presented.
Consecutive patients with PPI underwent interventions with an adjustable transobturator male system (ATOMS) or artificial urinary sphincter (AUS). Decisions were based on patient preference after physician counselling. Patient characteristics and operative and postoperative parameters including dryness, satisfaction, complications, revision and device durability were evaluated.
One hundred twenty-nine patients were included: 102 (79.1%) received ATOMS and 27 (20.9%) AUS. Mean follow-up was 34.9 ± 15.9 months. No difference was observed between patient age (p = 0.56), ASA score (p = 0.13), Charlson index (p = 0.57) and radiation (p = 0.3). BMI was higher for AUS (27.1 vs. 29.7; p = 0.003) and also baseline incontinence severity (7.9% mild, 44.1% moderate and 48% severe for ATOMS vs. 11.1% moderate and 88.9% severe for AUS; p = 0.0007). Differential pad test was higher for AUS (- 470 vs. - 1000 ml; p < 0.0001) and so was ICIQ-SF (15.62 vs. 18.3; p < 0.001), but total dryness (76.5 vs. 66.7%; p = 0.33), social continence (90.2 vs. 85.2%; p = 0.49) and satisfaction (92.2 vs. 88.9%; p = 0.69) were equivalent. The postoperative complication rate was similar (22.6 vs. 29.6%; p = 0.4). The surgical revision rate was higher for AUS (6.9 vs. 22.2%; p = 0.029) and also the explant rate but did not reach statistical significance (4.9 vs. 14.8%; p = 0.09). Time to explant was shorter for AUS (log-rank p = 0.021). Regression analysis revealed radiation (p = 0.003) and incontinence severity (p = 0.029) predict total dryness, while complications (p < 0.005) and type of device (p = 0.039) independently predict surgical revision.
Both ATOMS and AUS are effective devices. Pad test change for AUS exceeds that of ATOMS. The revision rate is higher for AUS, and durability is superior for ATOMS. The satisfaction rate is equivalent. Larger series and longer follow-up are needed to compare both devices more appropriately. According to our experience, the AUS is not the only gold standard for PPI.
本研究前瞻性评估了一系列接受两种不同设备治疗的前列腺切除术后尿失禁(PPI)患者的结局。
接受过治疗的 PPI 患者接受了可调经肛男性系统(ATOMS)或人工尿道括约肌(AUS)的干预。在医生咨询后,根据患者的偏好做出决定。评估患者特征和手术及术后参数,包括干燥、满意度、并发症、翻修和设备耐用性。
共纳入 129 例患者:102 例(79.1%)接受 ATOMS 治疗,27 例(20.9%)接受 AUS 治疗。平均随访 34.9±15.9 个月。患者年龄(p=0.56)、ASA 评分(p=0.13)、Charlson 指数(p=0.57)和放疗(p=0.3)无差异。AUS 的 BMI 更高(27.1 比 29.7;p=0.003),基线失禁严重程度也更高(ATOMS 组轻度 7.9%,中度 44.1%,重度 48%;AUS 组中度 11.1%,重度 88.9%;p=0.0007)。AUS 的差异垫试验更高(-470 比-1000ml;p<0.0001),ICIQ-SF 也更高(15.62 比 18.3;p<0.001),但总干燥度(76.5%比 66.7%;p=0.33)、社会持续性(90.2%比 85.2%;p=0.49)和满意度(92.2%比 88.9%;p=0.69)相当。术后并发症发生率相似(22.6%比 29.6%;p=0.4)。AUS 的手术翻修率更高(6.9%比 22.2%;p=0.029),同时也有更高的设备去除率,但未达到统计学意义(4.9%比 14.8%;p=0.09)。AUS 的设备去除时间更短(对数秩检验 p=0.021)。回归分析显示,放疗(p=0.003)和失禁严重程度(p=0.029)预测总干燥度,而并发症(p<0.005)和设备类型(p=0.039)独立预测手术翻修。
ATOMS 和 AUS 都是有效的设备。AUS 的垫试验变化大于 ATOMS。AUS 的翻修率更高,而 ATOMS 的耐用性更好。满意度相当。需要更大的系列和更长的随访时间来更恰当地比较两种设备。根据我们的经验,AUS 并不是 PPI 的唯一金标准。