About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult men and women 18 years and older
Presenting to clinic with symptoms of UTI or cystitis
Patients with Medicare and Medicaid insurance
Disqualifiers
Urinary diversion of any type
Chronic indwelling urinary catheter
Diagnosed UTI within the previous 21 days
Antibiotic therapy within the previous 21 days
Trial design
Parallel
Treatments tested in this trial
DNA PCR
DeviceGene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.
Urine Culture
Diagnostic testUrine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Length of time from patient presentation to initiation of treatment as measured by medical record review
Number of antibiotic changes as measured by medical record review
Duration of antibiotic use as measured by medical record review
Duration will be measured in days
Number of times participant represents with UTI symptoms as measured by medical record review
Duration will be measured in days
Sponsors and contacts
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