Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Cystoscopy
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|ClinicalTrials.gov Identifier: NCT02922868|
Recruitment Status : Completed
First Posted : October 4, 2016
Results First Posted : February 22, 2018
Last Update Posted : September 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bacteriuria||Device: EndoSheath CST-5000 Scope Device: Olympus Visera Elite OTV-S190 Scope||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922868
|United States, North Carolina|
|Wake Forest Baptist Health - Department of Urology|
|Winston-Salem, North Carolina, United States, 27103|
|Principal Investigator:||Gopal H Badlani, M.D.||Wake Forest University Health Sciences|