OAB and the Microbiome

University of Miami39 enrolled

Overview

To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Overactive Bladder Urgency-frequency Syndrome

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 y/o-90 y/o * Able to consent * Group A only: Urgency and Frequency Syndrome or OAB only. UDI-6 answer of "moderately" to "quite a bit" on questions 1 or 2. * Group B only: Urinary Distress Inventory 6 (UDI-6) answer "not at all" or "somewhat" for questions 1 or 2. Exclusion Criteria: * Pregnant * Pelvic radiation * Urinary retention (\>200 ml) * Renal calculi * Recurrent urinary tract infection (UTI) (2 in 6 months), or * Current UTI * Immunosuppressed or radiation history * Neurologic disorder

Locations (2)

Holy Cross Hospital

Fort Lauderdale, Florida, United States

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Proportion of patients with Lactobacillus in samples.

Evaluation of urine and perineal samples by PCR.

Time frame: Day 1

Proportion of patients negative for repeat sequencing.

Evaluation of urine and perineal samples by PCR.

Time frame: Day 1

Proportion of patients with change in UDI-6 score

UDI 6 question 1 and 2 has a total score from 0-6 with a high score indicating more distress. Proportion of patients with a decrease in score from baseline will be reported for this outcome.

Time frame: Up to 4 weeks

Data from ClinicalTrials.gov

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