Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture

Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial

Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.

Study Overview

• Status: Recruiting
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Diagnostic test: Urine Culture; Device: DNA PCR

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana N Mitchell, MD, MBA, BSN; Phone Number: 216-844-1000; Email: diana.mitchell@uhhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals
      • Contact: Diana N Mitchell, MD, MBA, BSN; Phone Number: 216-844-1000; Email: diana.mitchell@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult men and women 18 years and older
• Presenting to clinic with symptoms of UTI or cystitis
• Patients with Medicare and Medicaid insurance

Exclusion Criteria:

• Urinary diversion of any type
• Chronic indwelling urinary catheter
• Diagnosed UTI within the previous 21 days
• Antibiotic therapy within the previous 21 days
• Use of phenazopyridine within the previous 21 days
• Commercial insurance
• Non-English speaking
• Pregnant patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DNA Polymerase Chain Reaction (PCR); Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.	Device: DNA PCR; Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.
Active Comparator: Urine Culture; Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.	Diagnostic test: Urine Culture; Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in symptoms as measured by UTI-SIQ-8 questionnaire	The UTI-SIQ-8 is an eight item questionnaire that asks about symptom severity and symptom impairment on a likert scale from 0 to 4, 0 being not at all and 4 being very strong/very severe.	Baseline, one day after antibiotic completion
Change in symptoms as measured by the UTI Symptom Assessment questionnaire	The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms.	Baseline, one day after antibiotic completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of time from patient presentation to initiation of treatment as measured by medical record review		Up to 21 days
Number of antibiotic changes as measured by medical record review		Up to 21 days
Duration of antibiotic use as measured by medical record review	Duration will be measured in days	Up to 21 days
Number of times participant represents with UTI symptoms as measured by medical record review	Duration will be measured in days	Up to 30 days
Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review		Up to 21 days
Number of hospitalizations related to UTI as measured by medical record review		Up to 21 days

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: David Sheyn, MD, University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: DNA PCR; urine culture
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections; Investigative Techniques; Genetic Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Molecular Probe Techniques; Random Amplified Polymorphic DNA Technique
• Other Study ID Numbers: STUDY20241345

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No