The Utility of Urinalysis Prior to In-Office Procedures

Urinary Tract Infections Clinical Trial

Official title:

The Utility of Urinalysis Prior to In-Office Procedures: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526484
• Other study ID #: 2017-1124
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	William S. Middleton Memorial Veterans Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients who Developed a Urinary Tract Infection Post Procedure	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.	1 year