Mirabegron and Urinary Urgency Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Mirabegron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patients receive mirabegron daily for 12 weeks
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirabegron<br>Participants received mirabegron (Myrbetriq) daily for 12 weeks | Drug: Mirabegron<br>* Mirabegron is a medication for the treatment of overactive bladder. It was developed by Astellas Pharma and was approved by the United States Food and Drug Administration (FDA) in July 2012.<br>* Other names: Betmiga;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to Therapy | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) | 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. | 12 weeks | 
| Change in Urinary Distress Inventory (UDI) | 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. | 12 weeks | 
| Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score | 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. | 12 weeks | 
| Change in Colo-Rectal-Anal Distress Inventory (CRADI) | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mirabegron, Myrbetriq, Betmiga, Urinary Urgency Incontinence