Trial Outcomes & Findings for Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Cystoscopy (NCT NCT02922868)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

10-14 Days Post Procedure

Results posted on

2018-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	EndoSheath CST-5000 Scope Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope. EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.	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. Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EndoSheath CST-5000 Scope n=30 Participants Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope. EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.	Olympus Visera Elite OTV-S190 Scope n=30 Participants 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. Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EndoSheath CST-5000 Scope n=30 Participants Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope. EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.	Olympus Visera Elite OTV-S190 Scope n=30 Participants 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. 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	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EndoSheath CST-5000 Scope n=30 cystoscope locations Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope. EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.	Olympus Visera Elite OTV-S190 Scope n=30 cystoscope locations 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. Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope
Number of Cystoscopes With Positive Bioburden Post-procedure. Shaft	0 bioburdens	4 bioburdens
Number of Cystoscopes With Positive Bioburden Post-procedure. Body	0 bioburdens	0 bioburdens

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	EndoSheath CST-5000 Scope n=30 Participants Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope. EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.	Olympus Visera Elite OTV-S190 Scope n=30 Participants 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. Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope
Total Time to Reprocess a Cystoscope	270.91 seconds Standard Error 190	3838.78 seconds Standard Error 1270

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EndoSheath CST-5000 Scope n=30 Participants Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope. EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.	Olympus Visera Elite OTV-S190 Scope n=30 Participants 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. Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope
Subject Assessment of Procedure. VAS Pain	29.3 units on a scale Standard Error 23	26.5 units on a scale Standard Error 20.77
Subject Assessment of Procedure. VAS Discomfort	30.79 units on a scale Standard Error 21.41	29.2 units on a scale Standard Error 17.57

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EndoSheath CST-5000 Scope n=30 Participants Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope. EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.	Olympus Visera Elite OTV-S190 Scope n=30 Participants 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. Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope
Staff Assessment of Cystoscope Reprocessing. Ease of Insertion	4.27 units on a scale Standard Error 0.76	4.72 units on a scale Standard Error 0.55
Staff Assessment of Cystoscope Reprocessing. Ease of Manipulation	4.13 units on a scale Standard Error 0.83	4.5 units on a scale Standard Error 0.8
Staff Assessment of Cystoscope Reprocessing. Optical Quality	3.9 units on a scale Standard Error 1.15	4.3 units on a scale Standard Error 1.12
Staff Assessment of Cystoscope Reprocessing. Overall Ease of Use	4.02 units on a scale Standard Error 0.93	4.45 units on a scale Standard Error 0.85

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EndoSheath CST-5000 Scope n=30 Participants Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope. EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.	Olympus Visera Elite OTV-S190 Scope n=30 Participants 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. Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope
Total Cost of Cystoscopy Reprocessing	57,000.00 Dollars	32,000.00 Dollars

SECONDARY outcome

Timeframe: Per day.

Number of procedures per day per scope. On a daily basis urology outpatient clinic performs an average of 5 cystoscopies.

Outcome measures

Outcome measures
Measure	EndoSheath CST-5000 Scope n=30 Participants Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope. EndoSheath CST-5000 Scope: Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.	Olympus Visera Elite OTV-S190 Scope n=30 Participants 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. Olympus Visera Elite OTV-S190 Scope: Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope
Number of Procedures Per Day Per Scope.	5 Number of procedures per day per scope Standard Deviation 2	5 Number of procedures per day per scope Standard Deviation 2

Adverse Events

EndoSheath CST-5000 Scope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Olympus Visera Elite OTV-S190 Scope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Gopal Badlani

Wake Forest

Phone: 3367165928

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place