Clinical Trial: Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Cystoscopy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Flexible Cystoscopy

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: The Change in Bacteriuria [ Time Frame: 10-14 Days ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bioburden evaluation of cystoscope post-procedure. [ Time Frame: Immediately after cystoscopy. ]
    Immediately after completion of each cystoscopy procedure, the bioburden on the cystoscopes will be evaluated.
  • Evaluation of cystoscopy reprocessing time. [ Time Frame: Beginning from the time a cystoscope is withdrawn from the urethral meatus at the end of a procedure until the completion of reprocessing. ]
    The total time required for a cystoscope to be reprocessed so that it is available for re-use in a subsequent procedure will be measured.
  • Subject assessment of procedure. [ Time Frame: Immediately after procedure. ]
    After undergoing cystoscopy, patients will be asked to complete Visual Analog Scales (VAS) instruments to determine their level of pain experienced during cystoscopy as well as their perception of discomfort with the procedure.
  • Staff assessment of cystoscope reprocessing. [ Time Frame: At the end of each day. ]
    At the end of each day while the study is in progress, medical staff directly involved with the reprocessing of cystoscopes will evaluate the ease of reprocessing based on a 5-point Likert scale.
  • Evaluation of cystoscopy reprocessing economics. [ Time Frame: Beginning from the time a cystoscope is withdrawn from the urethral meatus at the end of a procedure until the completion of reprocessing. ]
    The health economics of reprocessing will be evaluated by associating personnel hourly costs with cystoscope reprocessing time segments.
  • Number of procedures per day per scope. [ Time Frame: Per day. ]
    Number of procedures per day per scope.


Original Secondary Outcome:

Information By: Wake Forest University Health Sciences

Dates:
Date Received: September 2, 2016
Date Started: March 2016
Date Completion:
Last Updated: April 17, 2017
Last Verified: April 2017