Urinary Tract Infections
Conditions
Keywords
urine culture, DNA PCR
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.
Interventions
DEVICEDNA PCR
Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.
DIAGNOSTIC_TESTUrine Culture
Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms as measured by the UTI Symptom Assessment questionnaire | Baseline, one day after antibiotic completion | The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms. |
| Change in symptoms as measured by UTI-SIQ-8 questionnaire | Baseline, one day after antibiotic completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospitalizations related to UTI as measured by medical record review | Up to 21 days | — |
| 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 | — |
| Number of times participant represents with UTI symptoms as measured by medical record review | Up to 30 days | Duration will be measured in days |
| Duration of antibiotic use as measured by medical record review | Up to 21 days | Duration will be measured in days |
| Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review | Up to 21 days | — |
Countries
United States
Contacts
CONTACTDiana N Mitchell, MD, MBA, BSN
PRINCIPAL_INVESTIGATORDavid Sheyn, MD
University Hospitals
Outcome results
None listed