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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02981459
Study type Interventional
Source State University of New York at Buffalo
Contact
Status Withdrawn
Phase Phase 4
Start date December 8, 2017
Completion date June 2018

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