Mirabegron and Urinary Urgency Incontinence

Mirabegron is an FDA-approved medication for urgency incontinence. Evaluation of mirabegron's
influence on clinical symptoms should take into account the effect of the female urinary
microbiome (FUM) on patient response to treatment. Several bacterial species are more common
in overactive bladder patients than in asymptomatic controls.

Currently, physicians have limited ability to personalize urinary urgency incontinence
treatment, and thus the prescribed medication may provide minimal symptom relief for some
patients. Since the FUM can be assessed prior to treatment, this study proposes to determine
if baseline FUM assessment can provide insight into future symptoms relief with mirabegron
treatment.

Inclusion Criteria:

- Bothersome idiopathic (non-neurologic) urgency urinary incontinence (UUI) who recall ≥
5 urgency predominant urinary incontinence episodes in the prior week (urgency urinary
incontinence or mixed urinary incontinence-urgency predominant)

- No contraindications to taking mirabegron

- Patients on current OAB therapy will undergo a two-week drug washout period prior to
baseline assessment

Exclusion Criteria:

- Neurologic disease known to affect the lower urinary tract

- Systemic immunologic deficiency

- Current urinary tract infection (UTI) (based on dipstick assessment) or recurrent
culture-proven UTIs

- History or current pelvic malignancy or radiation

- Untreated symptomatic pelvic organ prolapse (POP) > POP-Q Stage II

- A contraindication to receiving mirabegron

- Women of childbearing potential who are pregnant or nursing or intend to become
pregnant during the study, or who are not practicing a reliable method of
contraception

- Must not have taken any antibiotics, for any reason, in the 4 weeks prior to
enrollment