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

NCT ID: NCT06808451

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-22

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DNA Polymerase Chain Reaction (PCR)

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

Group Type EXPERIMENTAL

DNA PCR

Intervention Type DEVICE

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

Urine Culture

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

Group Type ACTIVE_COMPARATOR

Urine Culture

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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DNA PCR

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

Intervention Type DEVICE

Urine Culture

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David Sheyn

Director, Division of Urogynecology and Reconstructive Pelvic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Sheyn, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Locations

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University Hospitals

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Diana N Mitchell, MD, MBA, BSN

Role: CONTACT

216-844-1000

Facility Contacts

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Diana N Mitchell, MD, MBA, BSN

Role: primary

216-844-1000

Other Identifiers

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STUDY20241345

Identifier Type: -

Identifier Source: org_study_id

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