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

A prospective multicenter randomized non-inferiority clinical trial study of a domestic disposable digital flexible cystoscope versus a reusable Olympus digital flexible cystoscope

目的比较国产一次性电子膀胱软镜与进口可重复使用电子膀胱软镜的疗效及安全性。方法本研究为前瞻性多中心随机对照临床试验,收集2018年8月至2019年3月武汉大学人民医院、厦门大学附属第一医院、广州医科大学附属第一医院符合条件的患者。纳入标准:年龄≥18岁,需行膀胱镜检查或取出双J管者。排除标准:泌尿男性生殖系急性感染、结核性膀胱挛缩、膀胱容量<50ml或尿道狭窄者;不能采取膀胱截石位者;女性月经期;妊娠或哺乳期妇女;有严重心脑血管疾病或肝肾功能不全者。采用分层区组随机化方法将患者按1:1比例随机分配至试验组与对照组。试验组采用国产一次性电子膀胱软镜(广州瑞派医疗器械有限责任公司),对照组采用进口可重复使用电子膀胱软镜(日本奥林巴斯医疗株式会社),两组患者行膀胱镜检查或膀胱镜检查+双J管取出。主要有效性指标为整体影像合格率,次要有效性指标为操作成功率、操作性能评分、手术时间,安全性指标为不良事件发生率和器械缺陷率。结果最终纳人188例,试验组95例,对照组93例。两组性别(男/女:58/37与62/31)、年龄[(48.4±13.0)岁与(48.7±12.6)岁]、体质指数[(24.1±2.5)kg/m^(2)与(24.3±3.2)kg/m^(2)]差异均无统计学意义(P>0.05)。试验组与对照组整体影像合格率[93.68%(89/95)与96.77%(90/93),P=0.52]、操作成功率[100.00%(95/95)与98.92%(92/93),P=0.49]、操作性能评分[(14.41±0.93)分与(14.56±0.84)分,P=0.23]差异均无统计学意义。试验组和对照组中仅行膀胱镜检查者(64例和65例)手术时间分别为(15.3±2.6)min和(15.4±3.3)min(P=0.93),行膀胱镜检查+双J管取出者(31例和28例)手术时间分别为(21.0±3.2)min和(21.7±3.9)min(P=0.69),两组差异均无统计学意义(P>0.05)。试验组与对照组不良事件发生率[8.42%(8/95)与9.68%(9/93)]差异无统计学意义(P=0.76)。两组均未发现器械缺陷。结论国产一次性电子膀胱软镜用于膀胱镜检查及取出双J管具有良好的有效性和安全性,在整体影像合格率、操作成功率、操作性能评分、平均手术时间、不良事件发生率和器械缺陷率等方面均非劣于进口可重复使用电子膀胱软镜。

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.MethodsFrom 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 5Oml,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.ResultsA 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.ConclusionsThere is no statistical dfference 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 noninferiority in the availability and safety compared with a reusable Olympus digital flexible cystoscope.