Sensitivity of Extended Cultures in Diagnosing Urinary Tract Infections

Terminated

• Conditions: Overactive Bladder; Overactive Detrusor; Urgency-Frequency Syndrome; UTI
• Interventions: Procedure: Extended Urine Culture

• Registration Number: NCT03080389
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Study Start: 2017-07-01
• Status Verified: 2018-08
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extended urine culture	Extended Urine Culture	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity of extended urine cultures compared to standard urine cultures.	one year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States