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首次使用FloStent用于对良性前列腺增生次要的导管依赖性尿液保留:RAPID I研究的其他结果

Bilal Chughtai¹, Jennifer Polo², Ingrid Perscky³

¹Department of Urology, Northwell Health, Syosset, NY; Department of Urology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY.

|September 18, 2025

概括

该FloStent装置允许大多数患有良性前列腺增生症 (BPH) 的男性在没有导管的情况下排泄,在前列腺手术前提供安全的临时解决方案.

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
手术创新在外科创新.

背景情况:

良性前列腺增生症 (BPH) 经常导致尿路滞留,需要内置导管.
通过尿道切除前列腺 (TURP) 是一种标准的治疗方法,但患者可能会面临延迟.
对于等待 TURP 的导管依赖的 BPH 患者,需要有效的临时解决方案.

研究的目的:

评估新型FloStent设备的临床性能.
评估FloStent在与BPH相关的尿路保留的男性中实现无导管排泄的疗效.
为了确定FloStent的耐受性和安全性,作为TURRP之前的临时措施.

主要方法:

一项前性,首次在人身上进行的临床试验 (RAPID I研究) 招募了11名患有BPH和尿路保留的男性.
植入FloStent是在门诊环境中使用灵活的囊囊镜植入的.
患者被跟踪了12周,之后设备被移除,并进行 TURP.

主要成果:

所有11名参与者都获得了立即术后无导管状态.
在3个月后,72.7% (8/11) 的受试者仍然没有导管.
平均国际前列腺症状评分和生活质量评分有所改善;疼痛评分为零. 所有不良事件都是轻微的和自我限制的.

结论:

在大多数等待 TURP 的 BPH 患者中,FloStent 促进了无导管排泄.
该设备表现出良好的耐受性和有利的安全性.
对于与BPH相关的尿路滞留的男性来说,FloStent是一个有前途的临时管理选择.

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