Skip to main content
OpenTrials
Completed

NCT Number: NCT03526484

The Utility of Urinalysis Prior to In-Office Procedures

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Proportion of Patients who Developed a Urinary Tract Infection Post Procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 16, 2018
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.