Sensitivity of Extended Cultures in Diagnosing Urinary Tract Infections

NeuroTherapia, Inc.

Status: Terminated

Conditions: UTI; Overactive Detrusor; Urgency-Frequency Syndrome; Overactive Bladder

Treatments: Procedure: Extended Urine Culture

Study type: Observational

Funder types: Other

Identifiers

NCT03080389

FLA 16-108

Details and patient eligibility

About

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?

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

16 participants in 1 patient group

Extended urine culture

Description:

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.

Treatment:

Procedure: Extended Urine Culture