Bacteriuria
Conditions
Keywords
Cystoscopy, EndoSheath, Infection Control, Bacteriuria
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.
Interventions
DEVICEEndoSheath CST-5000 Scope
Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.
DEVICEOlympus Visera Elite OTV-S190 Scope
Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope
Sponsors
Cogenix Medical Corporation
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Post-Procedure Bacteriuria | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Time to Reprocess a Cystoscope | 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. | 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. |
| Number of Cystoscopes With Positive Bioburden Post-procedure. | 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 Cost of Cystoscopy Reprocessing | 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. | Per day. | Number of procedures per day per scope. On a daily basis urology outpatient clinic performs an average of 5 cystoscopies. |
| Staff Assessment of Cystoscope Reprocessing. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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 | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | EndoSheath CST-5000 Scope | Olympus Visera Elite OTV-S190 Scope | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 27 Participants | 52 Participants |
| Sex: Female, Male Female | 27 Participants | 25 Participants | 52 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoSheath CST-5000 Scope | Number of Participants Who Had Post-Procedure Bacteriuria | 0 Participants |
| Olympus Visera Elite OTV-S190 Scope | Number of Participants Who Had Post-Procedure Bacteriuria | 1 Participants |
Secondary
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EndoSheath CST-5000 Scope | Number of Cystoscopes With Positive Bioburden Post-procedure. | Shaft | 0 bioburdens |
| EndoSheath CST-5000 Scope | Number of Cystoscopes With Positive Bioburden Post-procedure. | Body | 0 bioburdens |
| Olympus Visera Elite OTV-S190 Scope | Number of Cystoscopes With Positive Bioburden Post-procedure. | Shaft | 4 bioburdens |
| Olympus Visera Elite OTV-S190 Scope | Number of Cystoscopes With Positive Bioburden Post-procedure. | Body | 0 bioburdens |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoSheath CST-5000 Scope | Number of Procedures Per Day Per Scope. | 5 Number of procedures per day per scope | Standard Deviation 2 |
| Olympus Visera Elite OTV-S190 Scope | Number of Procedures Per Day Per Scope. | 5 Number of procedures per day per scope | Standard Deviation 2 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoSheath CST-5000 Scope | Staff Assessment of Cystoscope Reprocessing. | Ease of Manipulation | 4.13 units on a scale | Standard Error 0.83 |
| EndoSheath CST-5000 Scope | Staff Assessment of Cystoscope Reprocessing. | Ease of Insertion | 4.27 units on a scale | Standard Error 0.76 |
| EndoSheath CST-5000 Scope | Staff Assessment of Cystoscope Reprocessing. | Optical Quality | 3.9 units on a scale | Standard Error 1.15 |
| EndoSheath CST-5000 Scope | Staff Assessment of Cystoscope Reprocessing. | Overall Ease of Use | 4.02 units on a scale | Standard Error 0.93 |
| Olympus Visera Elite OTV-S190 Scope | Staff Assessment of Cystoscope Reprocessing. | Overall Ease of Use | 4.45 units on a scale | Standard Error 0.85 |
| Olympus Visera Elite OTV-S190 Scope | Staff Assessment of Cystoscope Reprocessing. | Optical Quality | 4.3 units on a scale | Standard Error 1.12 |
| Olympus Visera Elite OTV-S190 Scope | Staff Assessment of Cystoscope Reprocessing. | Ease of Insertion | 4.72 units on a scale | Standard Error 0.55 |
| Olympus Visera Elite OTV-S190 Scope | Staff Assessment of Cystoscope Reprocessing. | Ease of Manipulation | 4.5 units on a scale | Standard Error 0.8 |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoSheath CST-5000 Scope | Subject Assessment of Procedure. | VAS Pain | 29.3 units on a scale | Standard Error 23 |
| EndoSheath CST-5000 Scope | Subject Assessment of Procedure. | VAS Discomfort | 30.79 units on a scale | Standard Error 21.41 |
| Olympus Visera Elite OTV-S190 Scope | Subject Assessment of Procedure. | VAS Pain | 26.5 units on a scale | Standard Error 20.77 |
| Olympus Visera Elite OTV-S190 Scope | Subject Assessment of Procedure. | VAS Discomfort | 29.2 units on a scale | Standard Error 17.57 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EndoSheath CST-5000 Scope | Total Cost of Cystoscopy Reprocessing | 57,000.00 Dollars |
| Olympus Visera Elite OTV-S190 Scope | Total Cost of Cystoscopy Reprocessing | 32,000.00 Dollars |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoSheath CST-5000 Scope | Total Time to Reprocess a Cystoscope | 270.91 seconds | Standard Error 190 |
| Olympus Visera Elite OTV-S190 Scope | Total Time to Reprocess a Cystoscope | 3838.78 seconds | Standard Error 1270 |