Clinical trial NCT03526484: The Utility of Urinalysis Prior to In-Office Procedures
Official title: The Utility of Urinalysis Prior to In-Office Procedures: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: UTI
Urinalysis
Urine Culture
Cystoscopy
BCG treatment
Prostate Biopsy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients who Developed a Urinary Tract Infection Post Procedure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kyle A Richards, MD
role: PRINCIPAL_INVESTIGATOR
References: