Mirabegron and Urinary Urgency Incontinence

Phase 4

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Mirabegron	Mirabegron	Participants received mirabegron (Myrbetriq) daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Response to Therapy	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 Outcome Measures

Name	Time	Method
Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)	12 weeks	The Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) score is a measure of patients' bladder symptom severity. It ranges from 25 to 150 where higher scores indicate greater quality of life.
Change in Urinary Distress Inventory (UDI)	12 weeks	The Urinary Distress Inventory is a 29-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity.
Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score	12 weeks	The Pelvic Organ Prolapse Distress Inventory (POPDI) is a 16-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity.
Change in Colo-Rectal-Anal Distress Inventory (CRADI)	12 weeks	The Colo-Rectal-Anal Distress Inventory (CRADI) is a 17-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 400 where higher scores indicate worsening symptom severity.