Urinary Tract Infections
Conditions
Keywords
UTI, Urinalysis, Urine Culture, Cystoscopy, BCG treatment, Prostate Biopsy
Brief summary
The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures.
Detailed description
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.
Interventions
BEHAVIORALStandard 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.
BEHAVIORALExperimental
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients receiving an in office cystoscopy, intravesical BCG treatment, or prostate biopsy
Exclusion criteria
* Patients under 18 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients who Developed a Urinary Tract Infection Post Procedure | 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. |
Countries
United States
Outcome results
None listed