Mirabegron and Urinary Urgency Incontinence

• Status: Completed
• Trial end date: 2019-01-29
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Collaborator: Astellas Pharma US, Inc.
• Treatments: Mirabegron

Criteria

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