Fernandez Adrian M, Patel Hiren V, Li Kevin D, Balakrishnan Ashwin S, Buie John, Ghaffar Umar, Hakam Nizar, Breyer Benjamin N
Department of Urology, University of California San Francisco, San Francisco, CA, USA.
Department of Urology, Texas Tech University Health Sciences Center, Lubbock, TX, USA.
Transl Androl Urol. 2025 May 30;14(5):1476-1483. doi: 10.21037/tau-24-587. Epub 2025 May 27.
Adjustable continence therapy for men (ProACT) is an inflatable para-urethral balloon approved for consumer use in the United States by the Food and Drug Administration in 2015. Post-approval adverse events (AEs) have been catalogued in Manufacturer and User Facility Device Experience (MAUDE). To characterize the complication profile of the device, we systematically reviewed all publications and MAUDE narratives outlining AEs related to ProACT.
Thirty-one peer-reviewed publications studying ProACT implantation in humans were identified by search of PubMed and Google Scholar using combination of keywords "ProACT", "balloon", and "continence". Eleven studies were excluded. The MAUDE database was searched for reports of AEs related to the placement of ProACT and narratives of AEs were characterized.
Of 1,607 patients treated in published studies, 752 AEs occurred. The most common were mechanical failure (n=224, 30%), device migration/malposition (n=155, 21%), and device erosion (n=120, 16%). Devices were explanted in 24% of patients and revised or reimplanted in 28% of cases. In the MAUDE database, the AEs identified were similar, with most common complications including device erosion (n=32, 49%), surgical site infection (n=15, 19%), and urinary retention (n=9, 11%).
Use of the ProACT device is associated with a high rate of AEs. Limitations include the lack of clinical details in the MAUDE database.
男性可调节控尿疗法（ProACT）是一种可充气的尿道旁球囊，2015年获美国食品药品监督管理局批准可供消费者使用。批准后的不良事件（AE）已在制造商和用户设施设备经验（MAUDE）中进行了编目。为了描述该设备的并发症情况，我们系统地回顾了所有概述与ProACT相关不良事件的出版物和MAUDE记录。
通过在PubMed和谷歌学术上搜索关键词“ProACT”、“球囊”和“控尿”的组合，确定了31篇研究ProACT在人体植入的同行评审出版物。排除了11项研究。在MAUDE数据库中搜索与ProACT放置相关的不良事件报告，并对不良事件的记录进行了描述。
在已发表研究中治疗的1607例患者中，发生了752起不良事件。最常见的是机械故障（n = 224，30%）、设备迁移/位置不当（n = 155，21%）和设备侵蚀（n = 120，16%）。24%的患者进行了设备取出，28%的病例进行了修订或重新植入。在MAUDE数据库中，识别出的不良事件相似，最常见的并发症包括设备侵蚀（n = 32，49%）、手术部位感染（n = 15，19%）和尿潴留（n = 9，11%）。
ProACT设备的使用与高不良事件发生率相关。局限性包括MAUDE数据库中缺乏临床细节。
