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

• ClinicalTrials.gov Identifier: NCT02922868
• Recruitment Status: Completed
• First Posted: October 4, 2016
• Results First Posted: February 22, 2018
• Last Update Posted: September 12, 2018
• Sponsor: Wake Forest University Health Sciences
• Collaborator: Cogenix Medical Corporation
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bacteriuria	Device: EndoSheath CST-5000 Scope; Device: Olympus Visera Elite OTV-S190 Scope	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Flexible Cystoscopy
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: EndoSheath CST-5000 Scope; Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.	Device: EndoSheath CST-5000 Scope; Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.
Active Comparator: Olympus Visera Elite OTV-S190 Scope; Olympus HD Flexible Cysto-Nephro Videoscope (CYF-VH) with Olympus Visera Elite Platform, including OTV-S190 Video Processor CLV-S190 Xenon Light Source. Olympus Visera Elite OTV-S190 Scope.	Device: Olympus Visera Elite OTV-S190 Scope; Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Had Post-Procedure Bacteriuria [ Time Frame: 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.

Secondary Outcome Measures :

1. Number of Cystoscopes With Positive Bioburden Post-procedure. [ Time Frame: Immediately after cystoscopy. ]
   Immediately after completion of each cystoscopy procedure, the bioburden on the cystoscopes will be evaluated. The flexible cystoscope sheath was removed for bioburden assessment. For each cystoscope, whether sheathed or standard, two locations were assessed - the control body and the shaft. Cultures were obtained wiping the entire surface with sterile saline pledgets. The sample pledgets were placed in 1 ml sterile saline and shaken for 30 seconds. Ten drops of 0.02 ml aliquots from the sample were spotted on two 5% blood agar plates and incubated at 35°C in CO2.
2. Total Time to Reprocess a Cystoscope [ 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, approximately 3,869 seconds ]
   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.
3. Subject Assessment of Procedure. [ Time Frame: Approximately 2 min after the end of 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. The score range is 0 to 100. Higher scores denotes worse outcomes.
4. Staff Assessment of Cystoscope Reprocessing. [ Time Frame: At the end of day of each procedure during 6 months ]
   At the end of each day while the study is in progress, 6 members of the medical staff directly involved with the reprocessing of cystoscopes will evaluate the ease of reprocessing based on a 5-point Likert scale for the following parameters: ease of Insertion, ease of manipulation, optical quality, overall ease of use. The score range is 0 to 5. Higher score denotes better outcomes. A single value was derived per staff member and summarized for the group as a whole during 6 months.
5. Total Cost of Cystoscopy Reprocessing [ Time Frame: 6 months ]
   The health economics of reprocessing will be evaluated by associating personnel hourly costs with cystoscope reprocessing time segments. The total cost was averaged between pre-cleaning, cleaning, disinfection, rinsing, and drying for the 30 cystoscopes in each group for a duration of 6 months.
6. Number of Procedures Per Day Per Scope. [ Time Frame: Per day. ]
   Number of procedures per day per scope. On a daily basis urology outpatient clinic performs an average of 5 cystoscopies.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, North Carolina

Wake Forest Baptist Health - Department of Urology

Winston-Salem, North Carolina, United States, 27103

Sponsors and Collaborators

Wake Forest University Health Sciences

Cogenix Medical Corporation

Investigators

• Principal Investigator: Gopal H Badlani, M.D.; Wake Forest University Health Sciences

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02922868
• Other Study ID Numbers: IRB00036203
• First Posted: October 4, 2016
• Results First Posted: February 22, 2018
• Last Update Posted: September 12, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Wake Forest University Health Sciences:

Cystoscopy; EndoSheath; Infection Control; Bacteriuria

Additional relevant MeSH terms:

Infections; Bacteriuria; Urinary Tract Infections; Urologic Diseases