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The Utility of Urinalysis Prior to In-Office Procedures

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Experimental
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Urinary Tract Infections focused on measuring UTI, Urinalysis, Urine Culture, Cystoscopy, BCG treatment, Prostate Biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • William S. Middleton Memorial Veterans Hospital
  • University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Experimental

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2018
Last Updated
November 30, 2021
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03526484
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
UTI, Urinalysis, Urine Culture, Cystoscopy, BCG treatment, Prostate Biopsy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
664 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm 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.
Arm Title
Experimental
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
The provider will review the urinalysis results prior to conducting the in-office procedure and will make clinical decisions taking into account those results.
Intervention Type
Behavioral
Intervention Name(s)
Experimental
Intervention Description
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 Outcome Measure Information:
Title
Proportion of Patients who Developed a Urinary Tract Infection Post Procedure
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle A Richards, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
William S. Middleton Memorial Veterans Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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The Utility of Urinalysis Prior to In-Office Procedures

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