The Utility of Urinalysis Prior to In-Office Procedures

University of Wisconsin (UW)

Status: Completed

Conditions: Urinary Tract Infections

Treatments: Behavioral: Standard of Care; Behavioral: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT03526484

A539998 (Other Identifier)

Protocol Version 5/28/2020 (Other Identifier)

SMPH\VOLUNTEER STAFF\UROLOGY (Other Identifier)

2017-1124

Details and patient eligibility

About

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

Full 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.

Enrollment: 664 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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664 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of Care

Experimental

Experimental group

Description:

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.

Treatment:

Behavioral: Experimental