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

NCT06808451 | Recruiting DMC FDA Device

• 1 other identifier: STUDY20241345
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infections

Keywords

urine culture; DNA PCR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  Up to 21 days

• Number of times participant represents with UTI symptoms as measured by medical record review

  Up to 30 days

• Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review

  Up to 21 days

Study Arms (2)

DNA Polymerase Chain Reaction (PCR)

EXPERIMENTAL

Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.

Device: DNA PCR

Urine Culture

ACTIVE COMPARATOR

Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.

Diagnostic Test: Urine Culture

Interventions

DNA PCR DEVICE

Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.

DNA Polymerase Chain Reaction (PCR)

Urine Culture DIAGNOSTIC_TEST

Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.

Urine Culture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Random Amplified Polymorphic DNA Technique

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Molecular Probe Techniques

Study Officials

• David Sheyn, MD

  University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana N Mitchell, MD, MBA, BSN

CONTACT

216-844-1000; diana.mitchell@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Urogynecology and Reconstructive Pelvic Surgery

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)