Department of Urology, University of Nice, Nice, France.
Department of Urology, University of Rennes, Rennes, France.
J Urol. 2021 Nov;206(5):1248-1257. doi: 10.1097/JU.0000000000001954. Epub 2021 Jun 29.
The main objective of this study was to assess the prevalence and risk factors of male artificial urinary sphincter (AUS) mechanical failures and nonmechanical failures.
The charts of all male patients who underwent AUS implantation between 2004 and 2020 in 16 centers were retrospectively reviewed. Patients with neurogenic stress urinary incontinence (SUI) were excluded as well as revisions/explantations due to infections and/or erosions. The causes of revision were divided into mechanical failures (fluid loss or malfunction from any components of the AUS), nonmechanical failures (urethral atrophy, recurrence/persistence of SUI despite normally functioning device) and other (pump malposition, balloon herniation, hematoma, pain). Failure-free survival analysis was performed both for general and specific causes of revision. Predictors of mechanical and nonmechanical failures were determined by Cox proportional hazards model.
A total of 1,020 patients met the inclusion criteria. After a median followup of 20 months, the estimated 5-year and 10-year overall revision-free survival was 60% and 40%, respectively. There were 214 AUS revisions: 59 (27.6%) for mechanical failures, 121 (56.5%) for nonmechanical failures and 34 (15.9%) other causes of revision. In multivariable Cox regression analysis, larger cuff size was the only predictor of overall revisions (HR=1.04 [1.01-1.07]; p=0.01) and revision for nonmechanical failure (HR=1.05 [1.02-1.09]; p=0.004).
Half of the male AUS patients underwent device revision within the first 10 years after implantation. Nonmechanical failures are the primary cause of AUS revision in nonneurological men. Larger cuff size appears to be the main determinant of AUS revision risk.
本研究的主要目的是评估男性人工尿道括约肌(AUS)机械故障和非机械故障的发生率和危险因素。
回顾性分析了 2004 年至 2020 年间 16 个中心接受 AUS 植入术的所有男性患者的病历。排除了因神经源性压力性尿失禁(SUI)而接受手术的患者,以及因感染和/或侵蚀而进行的翻修/取出的患者。翻修的原因分为机械故障(AUS 的任何部件的液体流失或故障)、非机械故障(尿道萎缩,尽管装置正常运作,但 SUI 仍复发/持续存在)和其他(泵位置不当、球囊疝出、血肿、疼痛)。对一般性和特定的翻修原因进行了无失败生存分析。通过 Cox 比例风险模型确定机械和非机械故障的预测因素。
共有 1020 名患者符合纳入标准。中位随访 20 个月后,估计 5 年和 10 年的整体无翻修生存率分别为 60%和 40%。有 214 例 AUS 翻修:59 例(27.6%)为机械故障,121 例(56.5%)为非机械故障,34 例(15.9%)为其他翻修原因。多变量 Cox 回归分析显示,更大的袖套尺寸是整体翻修(HR=1.04[1.01-1.07];p=0.01)和非机械性故障翻修(HR=1.05[1.02-1.09];p=0.004)的唯一预测因素。
一半的男性 AUS 患者在植入后的头 10 年内需要进行装置翻修。非机械性故障是男性非神经源性 AUS 翻修的主要原因。更大的袖套尺寸似乎是 AUS 翻修风险的主要决定因素。