首次对UroActive®电子人工泌尿器进行人类评估,用于治疗男性压力尿失禁 (SUI)
Pierre Mozer1,2, Aurelien Beaugerie1, Marie-Aimée Perrouin-Verbe3
1Sorbonne Université, Hôpital Universitaire Pitié Salpêtrière, Service d'urologie, AP-HP, 75013, Paris, France.
The Journal of urology
|January 21, 2026
概括
该UroActive®设备显示为治疗男性压力尿失禁 (SUI) 的承诺,在第一年内提供更好的结果和患者满意度. 需要进一步的研究来确定长期的疗效.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 医疗器械 医疗器械
- 临床试验 临床试验
背景情况:
- 压力尿失禁 (SUI) 显著影响男性的生活质量.
- 对SUI的保守和手术治疗有局限性,成功率各不相同.
研究的目的:
- 评估UroActive®设备在男性SUI的可行性,安全性和有效性.
- 在植入后的第一年评估设备的性能.
主要方法:
- 前性,多中心,单臂,首次在人身上进行的研究.
- 招募了6名男性患者,SUI对先前的治疗没有反应.
- 收集的数据包括设备激活,修订,扩展率,尿片测试,尿液流量计和患者报告的结果.
主要成果:
- 在所有6名患者 (100%) 中成功植入和激活.
- 在激活后的365天内,不需要设备扩展或修订.
- 显著减少了子的重量 (≥50%在所有,≥75%在83.3%) 和子的使用 (中位数3.7到1.0子/天).
- 改善了生活质量得分和最小的空虚后残留尿液.
- 与遥控器相关的9个设备缺陷;没有严重的不良事件.
结论:
- 该UroActive®设备是可行的和安全的治疗男性SUI,显示有希望的功能结果.
- 患者报告了明显的症状改善和高满意度.
- 建议进行更长的随访时间的大型研究,以确认设备的长期性能.
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