Department of Urology, Hospital Universitario Fundación Santa Fe de Bogotá and Universidad de los Andes School of Medicine, Bogotá, Colombia.
Department of Urology, Clínica FOSCAL, Bucaramanga, Colombia.
Neurourol Urodyn. 2022 Sep;41(7):1573-1581. doi: 10.1002/nau.25002. Epub 2022 Jul 21.
The artificial urinary sphincter (AUS) is one of the most effective surgical treatments for male urinary incontinence regardless of its severity. Current knowledge comes from high-volume centers, but little is known about the performance of this surgery from community practices. This study aims to report contemporary AUS performance in a nationwide observational study in Colombia.
Male patients who underwent AUS surgery with AMS 800™ between 2000 and 2020 in more than 17 centers and four cities were identified. Pre, intra, and postoperative characteristics were evaluated, mainly addressing patient reported outcomes measurements in the postoperative period. Retrospective and prospective data collection and descriptive analysis were completed. Kaplan-Meier analysis was used to determine AUS survival rate.
Out of an initial 667 cases, a total of 215 patients met inclusion and exclusion criteria and were included. Mean age was 67 ± 9.4 years, and mean follow-up was 6.0 ± 4.4 years with maximum range of 14 years. The etiology of urinary incontinence was prostate cancer surgery in 141 (81%) of the cases. The rest of the cases were related to benign prostatic disease or spinal cord injury. It is noteworthy that out of 115 patients, only 59 (51.3%) reported previous formal pelvic floor rehabilitation. Subjective severity of urinary incontinence determined by a visual analog scale showed a decrease in 4.5 points after sphincter implantation. Sphincter removal was required in 50 (23.2%) cases. The main reasons for implant removal were urethral erosion and infection. The sphincter survival rate at 2, 5, 8, 10, and 14 years was 76%, 70%, 60%, 57%, and 17%, respectively. Of the subjects at the last follow-up with the device still in place, 80.7% defined their urinary condition as "does not cause or causes minor discomfort," and 99% would recommend the device to a friend or relative in the same condition.
This series from a community-based practice shows the lack of adherence to clinical practice guidelines and the lack of standardized data collection. In contrast, this study provides real-world data on explantation and revision rates, allows physicians to inform patients and to have clear metrics for a shared decision-making process before the procedure.
人工尿道括约肌（AUS）是治疗男性尿失禁最有效的手术方法之一，无论其严重程度如何。目前的知识来自于大容量中心，但关于社区实践中这种手术的表现知之甚少。本研究旨在报告哥伦比亚全国性观察研究中 AUS 的最新表现。
在 17 个以上中心和四个城市中，对 2000 年至 2020 年间接受 AMS 800™ 人工尿道括约肌手术的男性患者进行了识别。评估了术前、术中、术后的特征，主要针对术后患者报告的结果测量。完成了回顾性和前瞻性数据收集和描述性分析。使用 Kaplan-Meier 分析确定 AUS 的存活率。
在最初的 667 例患者中，共有 215 例符合纳入和排除标准并被纳入研究。平均年龄为 67±9.4 岁，平均随访时间为 6.0±4.4 年，最长随访时间为 14 年。尿失禁的病因是 141 例（81%）前列腺癌手术，其余病例与良性前列腺疾病或脊髓损伤有关。值得注意的是，在 115 例患者中，只有 59 例（51.3%）报告了以前的正式盆底康复。使用视觉模拟量表确定的尿失禁主观严重程度在植入括约肌后降低了 4.5 分。50 例（23.2%）需要取出括约肌。植入物取出的主要原因是尿道侵蚀和感染。植入物 2、5、8、10 和 14 年的存活率分别为 76%、70%、60%、57%和 17%。在最后一次随访时仍保留装置的患者中，80.7%的人将自己的尿控情况定义为“不会造成或只会造成轻微不适”，99%的人会向同样情况的朋友或亲戚推荐该装置。
这项来自社区实践的研究系列表明，存在临床实践指南遵循不足和数据收集标准化缺失的问题。相比之下，本研究提供了关于取出和翻修率的真实世界数据，使医生能够在手术前告知患者，并为他们提供共同决策过程的明确指标。
