软性输尿管镜检查中新型非侵入性肾内压监测装置：一项体外对比研究。

Novel non-invasive intrarenal pressure monitoring devices in flexible ureteroscopy: an in-vitro comparative study.

作者信息

Yuen Steffi Kar Kei, Chen Zixiao, Yuen Skyler, Liu Alex Qinyang, Leung Chi-Ho, Ko Ivan Ching Ho, Chan Chi Kwok, Somani Bhaskar, Herrmann Thomas, Jung Helene, Tokas Theodoros, Croghan Stefanie, Traxer Olivier, Chiu Peter Ka Fung, Chew Ben, Teoh Jeremy Yuen Chun, Gauhar Vineet, Li Zheng, Ng Chi Fai

机构信息

S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.

European Association of Urology Section of Endourology (ESEUT), Arnhem, The Netherlands.

出版信息

World J Urol. 2025 Jun 30;43(1):402. doi: 10.1007/s00345-025-05761-8.

DOI:10.1007/s00345-025-05761-8

PMID:40586977

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12209378/

Abstract

PURPOSE

Intrarenal pressure monitoring is emerging as an important tool in flexible ureteroscopy. Novel non-invasive intrarenal pressure monitoring devices are introduced. We evaluated the pressure readings simultaneously across four novel non-invasive intrarenal pressure monitoring devices against the urodynamic system.

MATERIALS AND METHODS

Two IRP monitoring single-use flexible ureteroscopy: LithoVue Elite (Boston Scientific Corporation, Marlborough, MA, USA); ZebraScope (Happiness Works Medical Instruments Co., Ltd, Anhui, China); two intelligent intrarenal system integrated with irrigation and suction via flexible and navigable suction ureteral access sheath: i-MIMERsys (ZSR Biomedical Technology Co., Ltd, Dongguan, China); Tidor (YiGao Medical Technology Co., Ltd, Zhejiang, China) were tested against MMS/Laborie Nexam Pro Urodynamic System (Laborie Medical Technologies Corporation, Portsmouth, USA).

RESULTS

The degree of agreement between measurements from urodynamic system and the experimented device was demonstrated by Bland-Altman plots and intraclass correlation coefficients (ICCs). Compared to the urodynamic system, the average difference ± standard deviation of LithoVue Elite™ was 0.26 ± 1.75mmHg; ZebraScope™ 3.22 ± 1.86mHg, i-MIMERsys™ 0.96 ± 2.26mmhg; Tidor™ 1.09 ± 2.57mmHg. Pressure measured by LithoVue Elite™, ZebraScope™, i-MIMERsys™ and Tidor™ to urodynamic system showed excellent ICCs of 0.975 (p < 0.001), 0.915(p = 0.016), 0.955(p < 0.001) and 0.937(p < 0.001) respectively.

CONCLUSION

Pressure recordings from four novel non-invasive intrarenal monitoring devices, namely flexible ureteroscopes-LithoVue Elite, ZebraScope; and intelligent IRP monitoring systems via flexible and navigable suction ureteral access sheaths - i-MIMERsys, Tidor. were comparable to that of urodynamic system. This in-vitro study verifies that such non-invasive devices provide reliable data for monitoring intrarenal pressure changes.

摘要

目的

肾内压监测正在成为软性输尿管镜检查中的一项重要工具。新型非侵入性肾内压监测设备已被引入。我们针对尿动力学系统，同时评估了四种新型非侵入性肾内压监测设备的压力读数。

材料与方法

两种用于肾内压监测的一次性软性输尿管镜：LithoVue Elite（美国波士顿科学公司，马尔伯勒，马萨诸塞州）；ZebraScope（中国安徽幸福伟业医疗器械有限公司）；两种通过软性可导航输尿管吸引鞘集成了冲洗和吸引功能的智能肾内系统：i-MIMERsys（中国东莞ZSR生物医学技术有限公司）；Tidor（中国浙江艺高医疗科技有限公司），针对MMS/Laborie Nexam Pro尿动力学系统（美国朴次茅斯Laborie医疗技术公司）进行测试。

结果

通过Bland-Altman图和组内相关系数（ICC）展示了尿动力学系统与实验设备测量值之间的一致性程度。与尿动力学系统相比，LithoVue Elite™的平均差值±标准差为0.26±1.75mmHg；ZebraScope™为3.22±1.86mmHg，i-MIMERsys™为0.96±2.26mmHg；Tidor™为1.09±2.57mmHg。LithoVue Elite™、ZebraScope™、i-MIMERsys™和Tidor™测量的压力与尿动力学系统相比，ICC分别为0.975（p<0.001）、0.915（p=0.016）、0.955（p<0.001）和0.937（p<0.001），均表现出色。