Bladder Irritable, Bladder Pain Syndrome, Urinary Frequency/Urgency
Conditions
Keywords
bladder pain, urinary frequency, urinary urgency, mirabegron
Brief summary
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
Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency. Specific Aims: 1. To measure the efficacy of Mirabegron in the treatment of frequency and urgency, using voiding diaries. 2. To measure the number of patients with a 50% or greater reduction in frequency and urgency, using voiding diaries. 3. 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: 1. Severe Liver disease, Child-Pugh class c 2. Severe Kidney disease, GFR\<30 3. Elevated blood pressure \> 160/95 (in package insert bp \>180/110) 4. Urinary retention 5. Pregnant, will become pregnant, or are nursing 6. History of recurrent urinary tract infection 7. Tachycardia: pulse \> 100 8. Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion 9. Medications - metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin
Interventions
DRUGMirabegron
daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks
Sponsors
Astellas Pharma Inc
State University of New York at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. English-speaking women 2. Age: 18 and 89 years 3. Pain related urinary frequency or urgency associated with \>70% of voids. With a minimum of 7 pain motivated voids in 24 hours. 4. Bladder capacity: \> 300 ml 5. Urinary frequency: 10 or more voids in 24/hours on voiding diary
Exclusion criteria
1. Severe Liver disease: Child-Pugh class c 2. Severe Kidney disease: GFR\<30 3. Elevated blood pressure \> 160/95 (in package insert bp \>180/110) 4. Pregnant, will become pregnant, or are nursing during the study 5. History of recurrent urinary tract infection: 3 or more culture proven urinary tract infections in the past 12 months. An active urinary tract infection. 6. Tachycardia: pulse \> 100, or any other history of arrhythmia 7. Intense urge: bladder volumes of \<150 ml on cystometry 8. Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion 9. Medications: metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin 10. 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. 11. 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. 12. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of pain motivated voids per 24 hours. | 12 weeks |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed