Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women

Study Overview
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Brief Summary
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The specific purpose of this study is to provide objective data in prospective open label design (n=40) to support the use of Mirabegron as a treatment for pain related urinary frequency and urgency. Women with bladder pain have a poor response to traditional anticholinergic therapy for their symptoms of frequency and urgency.

Detailed Description
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Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency. Specific Aims: To measure the efficacy of Mirabegron in the treatment of frequency and urgency, using voiding diaries. To measure the number of patients with a 50% or greater reduction in frequency and urgency, using voiding diaries. To measure the number of patients with a 50% or greater reduction in bladder pain as measured in the O'Leary-Sant (OLS) IC symptom and problem, and the Lowell Parsons Pelvic Pain and Urgency/Frequency (PUF) patient symptom scale. Intervention/Project goal: Treatment with Mirabegron 25mg for 4 weeks with an option for dose escalation to 50mg. Duration of study 12 weeks. Inclusion criteria: Women between the ages of 18 and 89 with complaints of pain related urinary frequency are eligible to participate in the study. Exclusion criteria: Patients will be excluded from the study if they have: Severe Liver disease, Child-Pugh class c Severe Kidney disease, GFR<30 Elevated blood pressure > 160/95 (in package insert bp >180/110) Urinary retention Pregnant, will become pregnant, or are nursing History of recurrent urinary tract infection Tachycardia: pulse > 100 Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion Medications - metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin

Official Title
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Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation

Conditions
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Urinary Frequency/Urgency, Bladder Irritable, Bladder Pain Syndrome

Intervention / Treatment
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* Drug: Mirabegron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking women Age: 18 and 89 years Pain related urinary frequency or urgency associated with >70% of voids. With a minimum of 7 pain motivated voids in 24 hours. Bladder capacity: > 300 ml Urinary frequency: 10 or more voids in 24/hours on voiding diary Exclusion Criteria: Severe Liver disease: Child-Pugh class c Severe Kidney disease: GFR<30 Elevated blood pressure > 160/95 (in package insert bp >180/110) Pregnant, will become pregnant, or are nursing during the study History of recurrent urinary tract infection: 3 or more culture proven urinary tract infections in the past 12 months. An active urinary tract infection. Tachycardia: pulse > 100, or any other history of arrhythmia Intense urge: bladder volumes of <150 ml on cystometry Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion Medications: metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin Pain medications: no dose changes in narcotic or non-steroidal medications while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit. Neurogenic pain medications such as gabapentin or amitriptyline: no dose changes while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit. Anticholinergic medications for incontinence: no dose changes while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirabegron 25 mg or 50 mg<br> | Drug: Mirabegron<br>* daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks<br>* Other names: Myrbetriq;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of pain motivated voids per 24 hours. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change from baseline to end of study in the daily average number of voids |  | 12 weeks | 
| The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ) |  | 12 weeks | 
| The mean change in the Patient Perception of Bladder Condition (PPBC) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder pain, urinary frequency, urinary urgency, mirabegron