Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome
Overview
- Phase
- Phase 4
- Intervention
- Mirabegron
- Conditions
- Overactive Bladder
- Sponsor
- Loyola University
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Response to Therapy
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Alan J. Wolfe
Professor
Loyola University
Eligibility 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
Arms & Interventions
Mirabegron
Participants received mirabegron (Myrbetriq) daily for 12 weeks
Intervention: Mirabegron
Outcomes
Primary Outcomes
Response to Therapy
Time Frame: 12 weeks
Response to therapy was measured using the Patient Perception of Bladder Control (PPBC) questionnaire which measures patients' perceived bladder condition on a 6-point ordinal scale ranging from 1 (no problems at all) to 6 (many severe problems). Women reporting a PPBC score of 4 or 5 by week 12 responded to therapy. Women reporting a PPBC score of 1, 2, or 3 by week 12 did not respond to therapy.
Secondary Outcomes
- Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)(12 weeks)
- Change in Urinary Distress Inventory (UDI)(12 weeks)
- Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score(12 weeks)
- Change in Colo-Rectal-Anal Distress Inventory (CRADI)(12 weeks)