Kim Simon P, Sarmast Zubair, Daignault Stephanie, Faerber Gary J, McGuire Edward J, Latini Jerilyn M
Department of Urology, The University of Michigan Health System and Medical School, Ann Arbor, Michigan 48109-0330, USA.
J Urol. 2008 May;179(5):1912-6. doi: 10.1016/j.juro.2008.01.048. Epub 2008 Mar 18.
The artificial urinary sphincter continues to be one of the most effective and commonly used surgical treatments for severe urinary incontinence. The long-term durability and functional outcome remains unclear. This study sought to report the artificial urinary sphincter complication rates, associated risk factors with complications, and long-term quality of life and durability.
This single institution study reports the outcomes of 124 consecutive index cases of artificial urinary sphincter from 1996 to 2006 for complications (infection, erosion, and mechanical failure). Bivariate statistics and multivariable logistic models were used to identify patient and artificial urinary sphincter characteristics associated with complications. Functional outcomes and long-term durability were assessed using a cross sectional analysis of a validated health related quality of life survey and a product limit estimates, respectively.
Among the 124 male patients median followup was 6.8 years. The overall complication rate for patients undergoing an artificial urinary sphincter was 37.0%, with mechanical failure the most common cause (29), followed by erosion (10) and then infection (7). Significant differences between complications and specific patient and artificial urinary sphincter characteristics risk factors were not found. Functional outcomes appeared stable with similar mild-moderate urinary incontinence severity and 0 to 1 daily pad use at intervals of 0 to 4 years, 4 to 8 years and more than 8 years. Long-term durability was notable with 36% having complications (requiring surgical revision or removal) within 10 years and most events occurring within the first 48 months.
Long-term durability and functional outcomes are achievable for the AMS 800, but there are appreciable complication rates for erosion, mechanical failure and infection in the first 48 months from implantation.
人工尿道括约肌仍然是治疗严重尿失禁最有效且常用的外科治疗方法之一。其长期耐用性和功能结果仍不明确。本研究旨在报告人工尿道括约肌的并发症发生率、并发症相关危险因素以及长期生活质量和耐用性。
本单机构研究报告了1996年至2006年连续124例初次植入人工尿道括约肌病例的并发症（感染、侵蚀和机械故障）情况。采用双变量统计和多变量逻辑模型来确定与并发症相关的患者和人工尿道括约肌特征。分别通过对经过验证的健康相关生活质量调查进行横断面分析以及产品寿命估计来评估功能结果和长期耐用性。
124例男性患者的中位随访时间为6.8年。接受人工尿道括约肌治疗的患者总体并发症发生率为37.0%，其中机械故障是最常见的原因（29例），其次是侵蚀（10例），然后是感染（7例）。未发现并发症与特定患者和人工尿道括约肌特征危险因素之间存在显著差异。功能结果似乎稳定，在0至4年、4至8年以及超过8年的时间间隔内，尿失禁严重程度为轻度至中度且每日使用尿垫0至1片的情况相似。长期耐用性值得注意，36%的患者在10年内出现并发症（需要手术翻修或移除），且大多数事件发生在最初的48个月内。
对于AMS 800人工尿道括约肌，可实现长期耐用性和功能结果，但在植入后的前48个月内，侵蚀、机械故障和感染的并发症发生率较高。
