The Utility of Urinalysis Prior to In-Office Procedures

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Behavioral: Standard of Care; Behavioral: Experimental

• Registration Number: NCT03526484
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2018-05-03
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-16
• Study Start: 2018-09-28
• Status Verified: 2021-11
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	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.
Experimental	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

William S. Middleton Memorial Veterans Hospital; 🇺🇸 Madison, Wisconsin, United States

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States