Department of Urology, Sorbonne Université, AP-HP, Sorbonne Université, Pitié-Salpêtrière Academic Hospital, Assistance Publique-Hôpitaux de Paris, 75013, Paris, France.
Department of Urology, Pitié-Salpêtrière Academic Hospital, Assistance Publique-Hôpitaux Paris, Paris, France.
World J Urol. 2024 Nov 21;42(1):643. doi: 10.1007/s00345-024-05352-z.
Artificial urinary sphincters (AUS) are largely used to treat severe urinary incontinence in men, due to reduced outlet resistance. The aim of this animal study was to assess safety of a new electronic artificial urinary sphincter (UroActive™, UroMems, France) on a castrated ram model.
RAM study was a non-clinical study, led in a center agreed for animal good laboratory practice studies. In 2019, 20 rams have been implanted with the UroActive device. There were 4 groups of rams, followed respectively 4, 13, 26 and 52 weeks after activation. Similarly to the test animals, 6 rams were operated and left unimplanted (sham group). The animals were implanted, and then let in recovery during 4 weeks before activation. At the activation, a pressure of 120 cmHO ± 10 cmHO was set. The occlusive cuff was in open position during the day, and in close position during the night, with an opening frequency of 15 min every 1 h and 45 min. At the end of the study, the animals were euthanized and expert pathologists analyzed the urinary system.
Implantation was successfully performed. Two implanted animals presented a infection at control unit site, which one required a premature euthanasia. In all other animals, no signs of discomfort or pain were noted. No urethral erosion or stenosis was observed.
This non-clinical study showed an objective analyze of consequences of an artificial urinary sphincter on local tissues in rams. Under the conditions of this safety study, the UroActive™ device is considered suitable for implantation around urethra.
人工尿道括约肌（AUS）主要用于治疗因出口阻力降低导致的男性严重尿失禁。本动物研究的目的是评估新型电子人工尿道括约肌（UroActiveTM，UroMems，法国）在去势公羊模型中的安全性。
RAM 研究是一项非临床研究，由一家符合动物良好实验室规范研究的中心进行。2019 年，20 只公羊被植入了 UroActive 装置。有 4 组公羊，分别在激活后 4、13、26 和 52 周进行了随访。与试验动物一样，有 6 只公羊接受了手术但未植入（假手术组）。动物被植入，然后在激活前进行 4 周的恢复。在激活时，设定压力为 120cmHO±10cmHO。在白天，闭塞袖套处于打开位置，在夜间处于关闭位置，每 1 小时开放 15 分钟，每 45 分钟开放一次。研究结束时，动物被安乐死，专家病理学家分析泌尿系统。
植入成功。2 只植入动物的控制单元部位出现感染，其中 1 只需要提前安乐死。在所有其他动物中，均未观察到不适或疼痛迹象。未观察到尿道侵蚀或狭窄。
这项非临床研究对公羊尿道周围人工尿道括约肌对局部组织的影响进行了客观分析。在本安全性研究的条件下，UroActiveTM 装置被认为适合植入尿道周围。
