Bacteriuria Clinical Trial
Official title:
Assessment of Infection Control, Practice Efficiency, and Health Economics of Sheathed Versus Standard Flexible Cystoscopy
NCT number | NCT02922868 |
Other study ID # | IRB00036203 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | December 2016 |
Verified date | August 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Health - Department of Urology | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | Cogenix Medical Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 10-14 Days Post Procedure | |
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. | Immediately after cystoscopy. | |
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. | 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 | |
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. | Approximately 2 min after the end of procedure. | |
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. | At the end of day of each procedure during 6 months | |
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. | 6 months | |
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. | Per day. |
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