NCT02981459

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

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Conditions

• Urinary Frequency/Urgency
• Bladder Irritable
• Bladder Pain Syndrome

Interventions

Type	Name	Description
DRUG	Mirabegron	daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks

Timeline

• Start date: 2017-12-08
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-12-05
• Last updated: 2020-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study