Mirabegron and Urinary Urgency Incontinence

Loyola University

Status and phase

Completed

Phase 4

Conditions

Overactive Bladder

Treatments

Drug: Mirabegron

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02495389

207102

Details and patient eligibility

About

This study is for women diagnosed with urinary urgency incontinence (UUI) or overactive bladder (OAB). Some patients continue to have symptoms even while taking medication for OAB. The purpose of this study is to estimate the number of women who respond to a medication called mirabegron and estimate change in symptom severity over 12 weeks of therapy. A secondary goal is to correlate the female urinary microbiome (FUM) with response to treatment and change in symptom severity over 12 weeks of therapy.

Full description

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

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

Enrollment

84 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 in the 4 weeks prior to enrollment