An interventional study of EndoSheath CST-5000 Scope and Olympus Visera Elite OTV-S190 Scope in Bacteriuria, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-12.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
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.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 37 interventional studies indexed under Bacteriuria.
Browse Bacteriuria studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Cogentix Medical CST-5000 Flexible Video Cystoscope with Slide-On® EndoSheath® Technology. EndoSheath CST-5000 Scope.
Device: EndoSheath CST-5000 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 EndoSheath CST-5000 Scope.
Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope
Number of Participants Who Had Post-Procedure Bacteriuria
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.
Time frame: 10-14 Days Post Procedure
Number of Cystoscopes With Positive Bioburden Post-procedure.
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.
Time frame: Immediately after cystoscopy.
Total Time to Reprocess a Cystoscope
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.
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
Subject Assessment 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.
Time frame: Approximately 2 min after the end of procedure.
Staff Assessment of Cystoscope Reprocessing.
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.
Time frame: At the end of day of each procedure during 6 months
Total Cost of Cystoscopy Reprocessing
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.
Time frame: 6 months
Number of Procedures Per Day Per Scope.
Number of procedures per day per scope. On a daily basis urology outpatient clinic performs an average of 5 cystoscopies.
Time frame: Per day.
| Milestone | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 30 |
| Not completed | 0 | 0 |
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.
| Participants | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope |
|---|---|---|
| Number of Participants Who Had Post-Procedure Bacteriuria | 0 | 1 |
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.
| bioburdens | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope |
|---|---|---|
| Shaft | 0 | 4 |
| Body | 0 | 0 |
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.
| seconds | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope |
|---|---|---|
| Total Time to Reprocess a Cystoscope | 270.91 ± 190 | 3838.78 ± 1270 |
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.
| units on a scale | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope |
|---|---|---|
| VAS Pain | 29.3 ± 23 | 26.5 ± 20.77 |
| VAS Discomfort | 30.79 ± 21.41 | 29.2 ± 17.57 |
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.
| units on a scale | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope |
|---|---|---|
| Ease of Insertion | 4.27 ± 0.76 | 4.72 ± 0.55 |
| Ease of Manipulation | 4.13 ± 0.83 | 4.5 ± 0.8 |
| Optical Quality | 3.9 ± 1.15 | 4.3 ± 1.12 |
| Overall Ease of Use | 4.02 ± 0.93 | 4.45 ± 0.85 |
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.
| Dollars | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope |
|---|---|---|
| Total Cost of Cystoscopy Reprocessing | 57,000.00 | 32,000.00 |
Number of procedures per day per scope. On a daily basis urology outpatient clinic performs an average of 5 cystoscopies.
| Number of procedures per day per scope | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope |
|---|---|---|
| Number of Procedures Per Day Per Scope. | 5 ± 2 | 5 ± 2 |
Collected over 15 days after procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EndoSheath CST-5000 Scope | — | 0/30 (0%) | 0/30 (0%) |
| Olympus Visera Elite OTV-S190 Scope | — | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 27 | 52 |
| >=65 years | 5 | 3 | 8 |
| Sex: Female, Male(Participants) | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope | Total |
|---|---|---|---|
| Female | 27 | 25 | 52 |
| Male | 3 | 5 | 8 |
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wake Forest University Health Sciences →