Standard of Care
BehavioralThe provider will review the urinalysis results prior to conducting the in-office procedure and will make clinical decisions taking into account those results.
NCT Number: NCT03526484
The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
OVERVIEW:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The provider will review the urinalysis results prior to conducting the in-office procedure and will make clinical decisions taking into account those results.
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.
Time frame: 1 year
Will compare difference in overall UTI rate between control and experimental groups.The results of the trial will be analyzed using a T-test for comparison of means, a Mann-Whitney U test for comparison of medians, Fisher's exact and chi-squared tests for comparison of categorical variables, and a logistic regression for predictors of UTI.
University of Wisconsin, Madison
Other
The Utility of Urinalysis Prior to In-Office Procedures: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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