Ahyai Sascha A, Ludwig Tim A, Dahlem Roland, Soave Armin, Rosenbaum Clemens, Chun Felix K-H, Fisch Margit, Schmid Marianne, Kluth Luis A
Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Urology, University Medical Center Göttingen, Göttingen, Germany.
BJU Int. 2016 Oct;118(4):625-32. doi: 10.1111/bju.13449. Epub 2016 Mar 22.
To evaluate continence and complication rates of bulbar single-cuff (SC) and distal bulbar double-cuff (DC) insertion in male patients with severe stress urinary incontinence (SUI) according to whether the men were considered low or high risk for unfavourable artificial urinary sphincter (AUS) outcomes.
In all, 180 male patients who underwent AUS implantation between 2009 and 2013 were followed according to institutional standards. Patients with previous pelvic radiation therapy, open bulbar urethral or UI surgery ('high risk') underwent distal bulbar DC (123 patients) insertion, all others ('low risk') had proximal bulbar SC (57) insertion. Primary and secondary endpoints consisted of continence and complication rates. Kaplan-Meier analysis determined explantation-free survival, and Cox regression models assessed risk factors for persistent UI and explantation.
The median follow-up was 24 months. Whereas there was no significant difference in pad usage/objective continence after SC vs DC insertion, superior rates of subjective/social continence and less persistent UI were reported by the patients with DC devices (all P ≤ 0.02). Overall, device explantation (erosion, infection or mechanical failure) occurred in 12.8% of patients. While early (<6 weeks) complication rates compared with SC patients were similar (P > 0.05), DC patients had a 5.7-fold higher risk of device explantation during late follow-up (P = 0.02) and significantly shorter explantation-free survival (log-rank, P = 0.003).
Distal bulbar DC insertion in patients with a 'high-risk' profile (previous pelvic radiation, urethral surgery) leads to similar objective continence, but higher explantation rates when compared with patients considered 'low risk' with proximal bulbar SCs. Randomised controlled trials comparing both devices will be needed to determine whether the higher explanations rates are attributable to the DC device or to underlying risk factors.
根据男性重度压力性尿失禁（SUI）患者被认为人工尿道括约肌（AUS）预后不良的低风险或高风险，评估球部单环（SC）和球部远端双环（DC）植入后的控尿率和并发症发生率。
按照机构标准对2009年至2013年间接受AUS植入的180例男性患者进行随访。既往接受过盆腔放疗、开放性球部尿道或尿失禁手术（“高风险”）的患者接受球部远端DC植入（123例患者），其他所有患者（“低风险”）接受球部近端SC植入（57例）。主要和次要终点包括控尿率和并发症发生率。采用Kaplan-Meier分析确定无取出存活情况，Cox回归模型评估持续性尿失禁和取出的危险因素。
中位随访时间为24个月。虽然SC植入与DC植入后在尿垫使用/客观控尿方面无显著差异，但使用DC装置的患者主观/社交控尿率更高，持续性尿失禁更少（所有P≤0.02）。总体而言，12.8%的患者发生了装置取出（侵蚀、感染或机械故障）。虽然与SC患者相比，早期（<6周）并发症发生率相似（P>0.05），但DC患者在随访后期装置取出风险高5.7倍（P=0.02），无取出存活时间显著缩短（对数秩检验，P=0.003）。
“高风险”（既往盆腔放疗、尿道手术）患者球部远端DC植入导致的客观控尿情况相似，但与被认为“低风险”的球部近端SC患者相比，取出率更高。需要进行比较这两种装置的随机对照试验，以确定较高的取出率是归因于DC装置还是潜在的危险因素。
