mirabegron for the treatment of pain motivated urinary frequency and urgency in women

Conditions: Urinary Frequency/Urgency; Bladder Irritable; Bladder Pain Syndrome

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.

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

Eligibility criteria:
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.

Keywords: bladder pain urinary frequency urinary urgency mirabegron