Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Flexible Cystoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants Who Had Post-Procedure Bacteriuria
研究概览
简要总结
The purpose of this research study is to compare the effectiveness and efficiency of using a sterile sheath (EndoSheath®) during cystoscopy versus a standard scope.
详细描述
The increasing costs in health care and enhanced infection control requirements necessitate the efficient and reliable use of frequently used techniques like cystoscopy. The health economics of cystoscopy are dependent on maintaining low levels of post-cystoscopy sequelae like urinary tract infection (UTI) and its potential precursors, significant asymptomatic bacteriuria and leukocytosis. Another key component of the economics and efficiency of cystoscopy is the time and cost related to the reprocessing of these devices in preparation for re-use. The use of disposable endoscope sheaths may limit the need for high level disinfection (HLD) between procedures and reduce reprocessing time and potentially prolong the cystoscope lifespan. The rationale for this study is to determine if a sheathed cystoscopy system would provide the desired cost and efficiency advantages compared to procedures done with non-sheathed cystoscopes. This is a prospective, randomized, parallel group, single center clinical trial to assess the clinical outcomes, practice efficiency and health economics of the use of sheathed cystoscopes (EndoSheath® System) compared to using standard (non-sheathed) cystoscopes. The study will evaluate the infection control (via the change in bacteriuria), clinical practice efficiency and costs of the EndoSheath technology with CST 5000 scope compared to standard cystoscopy with Olympus Visera Elite OTV-S190 digital flexible scope. There will be 30 subjects in the control group undergoing cystoscopy with the standard scope at the clinic, the Olympus Visera Elite, and 30 subjects in the study group undergoing cystoscopy with the EndoSheath system. The study is designed as a prospective, randomized controlled trial. There will be no active blinding of clinicians or subjects; however, it is anticipated that most subjects will be unaware of differences in the cystoscopy equipment that will be utilized in their routine procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, at least 18 years of age or older
- •Patients undergoing de novo or follow up diagnostic or therapeutic cystoscopy procedures in a Urology clinic setting
- •Antibiotic-free for at least 7 days prior to cystoscopy procedure
- •Patients willing to return to the clinic at approximately two weeks (10 -14 days) post-procedure for a urine test
排除标准
- •Patients with significant lower urinary tract obstruction, gross hematuria
- •Patients having an acute pelvic inflammatory disease or symptomatic UTI
- •Patients with urethral strictures
- •Patients with chronic pain conditions
- •Patients unwilling to return to the clinic at approximately two weeks (10 -14 days) for a urine test
结局指标
主要结局
Number of Participants Who Had Post-Procedure Bacteriuria
时间窗: 10-14 Days Post Procedure
The primary endpoint will be the change in bacteriuria pre- and post-procedure between EndoSheath CST-5000 cystoscope and standard (non-sheathed) Olympus Visera Elite OTV-S190 cystoscope during the course of routine clinical use in a urology clinic. The pre-procedure measurement of bacteriuria will occur on the day of the procedure. The post-procedure measurement of bacteriuria will occur approximately two weeks (10-14 days) post-procedure. This will be assessed by urine culture exams.
次要结局
- Subject Assessment of Procedure.(Approximately 2 min after the end of procedure.)
- Number of Procedures Per Day Per Scope.(Per day.)
- Number of Cystoscopes With Positive Bioburden Post-procedure.(Immediately after cystoscopy.)
- Total Time to Reprocess a Cystoscope(Beginning from the time a cystoscope is withdrawn from the urethral meatus at the end of a procedure until the completion of reprocessing, approximately 3,869 seconds)
- Staff Assessment of Cystoscope Reprocessing.(At the end of day of each procedure during 6 months)
- Total Cost of Cystoscopy Reprocessing(6 months)