The Utility of Urinalysis Prior to In-Office Procedures
NCT ID: NCT03526484
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
664 participants
INTERVENTIONAL
2018-09-28
2021-11-15
Brief Summary
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Detailed Description
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Current urology practice requires every patient to have a urinalysis lab done prior to any in-office procedures. If the patient's urinalysis is positive, they are then required to have a urine culture done, which takes 1-3 days to show results, and they may also be prescribed antibiotics. This practice may cause diagnostic delays, unnecessary cancellations of procedures, and the overuse of antibiotics.
The aim of this study is to assess the usefulness of urinalysis labs and urine cultures in patients prior to in-office cystoscopies, intravesical BCG treatments, and prostate biopsies. The investigators predict there is no difference in the number of cases of urinary tract infections in patients that undergo in-office procedures with or without a prior urinalysis. The investigators propose a change in protocol could allow for improved clinical efficiency, antibiotic stewardship, and be economically advantageous.
OUTLINE:
Participants will be randomly assigned to either receive standard of care before their procedure or have their procedure conducted by their provider without consulting the urinalysis results beforehand. Participants will have follow up questionnaires seven days and thirty days after their procedure. A total of 664 participants will be enrolled between the two study sites.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Standard of Care
The control group will have a urine sample taken for a urinalysis prior to their procedure, which will have a reflex urine culture done if urinalysis results are positive. The results of the urinalysis will be reported to the doctor performing the procedure. The provider may require participants to take antibiotics and/or delay their procedure as a result of the urinalysis.
Standard of Care
The provider will review the urinalysis results prior to conducting the in-office procedure and will make clinical decisions taking into account those results.
Experimental
The experimental group will have a urine sample taken for a urinalysis prior to their procedure, which will have a reflex urine culture done if urinalysis results are positive. The results of the urinalysis will NOT be reported to the doctor performing the procedure. Instead, the provider will conduct the procedure without looking at or acting upon the results of the urinalysis. The urinalysis and urine culture results will be monitored by the research team, and the participant will be informed if the urine culture results are positive for an infection.
Experimental
The provider will not review the urinalysis results prior to conducting the in-office procedure, and therefore will not make clinical decisions taking those results into account.
Interventions
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Standard of Care
The provider will review the urinalysis results prior to conducting the in-office procedure and will make clinical decisions taking into account those results.
Experimental
The provider will not review the urinalysis results prior to conducting the in-office procedure, and therefore will not make clinical decisions taking those results into account.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with symptomatic UTI infections at the time of recruitment
* Patients on antibiotics at the time of recruitment, not including prophylaxis
* Patients with a history of UTI within 1 year
* Patients with indwelling catheters
* Patients with clean intermittent catheterization
* Patients undergoing stent removals or with ureteral stents
18 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Kyle A Richards, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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William S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Protocol Version 5/28/2020
Identifier Type: OTHER
Identifier Source: secondary_id
A539998
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\VOLUNTEER STAFF\UROLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
2017-1124
Identifier Type: -
Identifier Source: org_study_id