Clinical trial NCT02922868: Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Cystoscopy
Official title: Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Flexible Cystoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacteriuria
Keywords: Cystoscopy
EndoSheath
Infection Control
Bacteriuria
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Cogenix Medical Corporation
First posted: 2016-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants Who Had Post-Procedure Bacteriuria
timeFrame: 10-14 Days Post Procedure
Secondary outcomes:
measure: Number of Cystoscopes With Positive Bioburden Post-procedure.
timeFrame: Immediately after cystoscopy.
measure: Total Time to Reprocess a Cystoscope
timeFrame: 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
measure: Subject Assessment of Procedure.
timeFrame: Approximately 2 min after the end of procedure.
measure: Staff Assessment of Cystoscope Reprocessing.
timeFrame: At the end of day of each procedure during 6 months
measure: Total Cost of Cystoscopy Reprocessing
timeFrame: 6 months
measure: Number of Procedures Per Day Per Scope.
timeFrame: Per day.
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health - Department of Urology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gopal H Badlani, M.D.
role: PRINCIPAL_INVESTIGATOR
References: