NCT03526484

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
664

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

September 28, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

3.1 years

First QC Date

May 3, 2018

Last Update Submit

November 30, 2021

Conditions

Urinary Tract Infections

Keywords

UTIUrinalysisUrine CultureCystoscopyBCG treatmentProstate Biopsy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care

Experimental

EXPERIMENTAL

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.

Behavioral: Experimental

Interventions

Standard of CareBEHAVIORAL

The provider will review the urinalysis results prior to conducting the in-office procedure and will make clinical decisions taking into account those results.

Standard of Care
ExperimentalBEHAVIORAL

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.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving an in office cystoscopy, intravesical BCG treatment, or prostate biopsy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

William S. Middleton Memorial Veterans Hospital

Madison, Wisconsin, 53705, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Kyle A Richards, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 16, 2018

Study Start

September 28, 2018

Primary Completion

November 15, 2021

Study Completion

November 15, 2021

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

US(2)