Sensitivity of Extended Cultures in Diagnosing Urinary Tract Infections

Study Overview
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Brief Summary
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There is some evidence to suggest standard urine cultures may not be adequate in identifying patients with low grade urinary tract infections. Therefore, there are patients with symptoms of frequency and urgency, being misdiagnosed with overactive bladder due to negative urine cultures. If this is true, could extended cultures be used to identify the false negative patients?

Detailed Description
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In 2014, Hilt, Evann et al published a study called Urine is not sterile, in which it was found via PCR and extended urine cultures, there is a microbiome that exists within the urinary bladder. In this study, 92% of the bacteria failed to be identified by a standard urine culture but 80% were identified with extended urine cultures. In further explorations of the significance of this microbiome, Pearce, Meghan et al. found that the female bladder consists of increased abundance of bacteria in patients with UUI; including Gardnerella and Lactobacilus gasseri. Then in 2015, a study by Thomas-White, Krystal et al. found that patients with urge urinary incontinence (UUI) who responded to treatment with Solifenacin had fewer and less diverse communities of bacteria when evaluated by PCR and extended urine cultures. The clinical significance of the bacteria identified is not well understood. However, these studies show that the presence of bacteria is being missed by standard cultures. Dune et al. found that of patients with UTI symptoms, 27.5% were standard culture negative but extended quantitative urine culture positive. This demonstrates that practitioners may be overlooking urinary tract infections in patients with frequency and urgency. Therefore, if bacteria within the urine can be detected with extended cultures, can this technique be used to improve detection and treatment of urinary infections in patients with symptoms of frequency and urgency? The hypotheses states that extended urine cultures are more sensitive in the identification of urinary tract infections in patients with symptoms of urgency and frequency. The secondary hypothesis is that treatment of the uropathogen identified on extended urine cultures will improve patient symptoms.

Official Title
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Are Extended Urine Cultures More Sensitive Than Standard Urine Cultures in Diagnosing Urinary Tract Infections in Patients With Urgency and Frequency?

Conditions
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UTI, Overactive Bladder, Overactive Detrusor, Urgency-Frequency Syndrome

Intervention / Treatment
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* Procedure: Extended Urine Culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 y/o-70 y/o Able to consent Urgency /Frequency Urge incontinence PUF score ≤ 4 Bother questionnaire #2 or #3 answered either a moderate amount or a lot Exclusion Criteria: Pregnant Pelvic radiation Chronic pelvic pain Urinary retention Greater than Stage 2 prolapse Renal calculi Recurrent UTI (2 in 6 months) Immunosuppressed Neurologic disorder No antibiotics in the past 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Extended urine culture<br>Each patient will be their own control and two specimens will be obtained from each participant. The first will be a catheterized urine sample to be sent for routine culture and the second will be collected from the same catheterized specimen and sent for extended culture. | Procedure: Extended Urine Culture<br>* Extended Urine Culture Standard cultures will include 0.001 ml of specimen plated on sheep blood agar and MacConkey agar. Plates were inoculated and incubated at 35 degrees Celsius for 24 hours. Samples were considered positive if there were 10^3 cfu or greater. The extended urine culture will be spun down by centrifuge (3000 rpm for 5 min) and 0.1 ml of the sediment will be cultured for 48 hours. The participants will fill out the Bother, UDI-6, and PUF questionnaires before the cultures. If a patient has a positive urine culture, the patient will be asked to repeat the questionnaires 7-30 days post treatment with antibiotics. A comparison will be made between the standard and extended urine cultures to assess for a difference in identification and treatment of uropathogens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of extended urine cultures compared to standard urine cultures. | Extended urine cultures are more sensitive in the identification of urinary tract infections in patients with symptoms of urgency and frequency then standard cultures as measured by a positive urine extended culture. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of uropathogens found on extended cultures result in negative repeat extended urine culture. | Treatment of uropathogens found on extended cultures result in negative repeat extended urine culture. | one year | 
| Treatment of uropathogens found on extended cultures improves urinary tract symptoms measured by the Bother and UDI-6 questionnaires | Treatment of the uropathogen identified on extended urine cultures improve patient's urgency and frequency symptoms measured by the Bother and UDI-6 questionnaires | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overactive bladder, overactive detrusor, urgency-frequency, urinary tract infection