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一个前性,随机控制的多中心试验,比较Bard Inlay Optima和Cook Universa软支架

Alexander Ngoo¹, Michael Kwok², Michelle Ong³

¹Department of Urology, Townsville University Hospital, Townsville, Queensland, Australia.

|August 12, 2023

概括

与Cook Universa软型支架相比,Bard Inlay Optima支架与pHreecoat涂层并没有显著减少尿路支架症状. 这两种支架在疼痛,尿道和性健康领域都显示出类似的结果.

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:

尿道支架通常用于治疗尿路阻塞.
与支架相关的症状可能会对患者的生活质量产生负面影响.
新型支架涂层旨在减轻这些症状.

研究的目的:

为了比较Bard Inlay Optima支架与pHreecoat涂层与Cook Universa软支架在减少尿路支架症状方面的有效性.
评估尿道,疼痛,一般性和性健康领域的差异,使用尿道支架症状问卷 (USSQ).

主要方法:

一个前性,双盲,随机对照试验,涉及140名患者.
患者接受了Bard Inlay Optima或Cook Universa软尿管支架.
在插入后的第1周和第3周评估了USSQ分数.

主要成果:

在这两种支架类型之间,USSQ指数的整体得分没有显著差异.
在第一周,Cook Universa软支架显示出尿路感染症状的症状得分更差.
库克世界软支架与第1周和第3周的医院代表率更高有关.

结论:

在Bard Inlay Optima支架上的抗炎性pHreecoat涂层没有导致整体术后尿道支架症状的显著改善.
虽然一些特定的症状领域显示了微小的差异,但患者报告的整体结果在支架之间是可比的.

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