A prospective multicenter randomized non-inferiority clinical trial study of a domestic disposable digital flexible cystoscope versus a reusable Olympus digital flexible cystoscope
10.3760/cma.j.cn112330-20210928-00515
- VernacularTitle:国产一次性电子膀胱软镜与可重复使用电子膀胱软镜比较的前瞻性多中心随机对照临床研究
- Author:
Yue XIA
1
;
Zongwei PAN
;
Guang SHAN
;
Bin CHEN
;
Ming LEI
;
Wenbiao LIAO
;
Liang CHEN
;
Lingchao MENG
;
Yunhe XIONG
;
Hong ZHENG
;
Huijun QIAN
;
Tianpeng WU
;
Sixing YANG
Author Information
1. 武汉大学人民医院泌尿外科 湖北省肾结石防治临床医学研究中心，武汉 430060
- Keywords:
Cystoscopy;
Flexible;
Disposable;
Multicenter;
Randomized controlled study;
Clinical trials
- From:
Chinese Journal of Urology
2022;43(9):690-695
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the availability and safety of a domestic disposable digital flexible cystoscope compared with a reusable Olympus digital flexible cystoscope in cystoscopy and removal of double J stent.Methods:From August 2018 to March 2019, patients were enrolled in this prospective, open, multicenter, randomized, parallel positive controlled clinical trial study, which were from department of Urology in Renmin Hospital of Wuhan University, the First Affiliated Hospital of Xiamen University and the First Affiliated Hospital of Guangzhou Medical University. The experimental group and control group were assigned into a 1∶1 ratio by random table method. Inclusion criteria included age≥18 years and have indications for cystoscopy or removal of double J stent. Exclusion criteria included patients having acute genitourinary tract infection, having tuberculous bladder contracture, bladder capacity less than 50ml, having urethrostenosis, female menstrual period, pregnancy and lactation, having difficulty for lithotomy position, having serious cardio-cerebrovascular disease and liver or kidney dysfunction. A domestic disposable digital flexible cystoscope was adopted in the experimental group, whereas a reusable Olympus digital flexible cystoscope was used in the control group. Acceptability of image was defined as primary availability indicator, while success rate of working and performance score were defined as secondary availability indicators and mean operating time was calculated for cystoscopy only and cystoscopy plus removal of double J stent respectively, yet rate of adverse event as well as rate of equipment defects were sorted as safety indicators.Results:A total of 188 cases which were listed in per protocol set completed the clinical trial study successfully. There were 95 cases in the experimental group and 93 cases in the control group. Acceptability of image was 93.68%(89/95) and 96.77%(90/93) respectively in two groups( P=0.52). Success rate of working was 100.00%(95/95) and 98.92%(92/93) respectively in two groups ( P=0.49). Performance score was 14.41±0.93 and 14.56±0.84 respectively in two groups ( P=0.23). Mean operating time (MOT) only for cystoscopy was (15.3±2.6) min and (15.4±3.3)min respectively in two groups ( P=0.93), while MOT for cystoscopy plus removal of double J stent was (21.0±3.2) min and (21.7±3.9) min respectively in two groups ( P=0.69). Rate of adverse event was 8.42%(8/95) and 9.68%(9/93) respectively in two groups( P=0.76). There was no equipment defects in both groups. Conclusions:There is no statistical difference in acceptability of image, success rate of working, performance score, mean operating time for cystoscopy or removal of double J stent, rate of adverse events and rate of equipment defects. A domestic disposable digital flexible cystoscope has shown non-inferiority in the availability and safety compared with a reusable Olympus digital flexible cystoscope.
