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

Bladder Pain Syndrome Clinical Trial

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

Status Withdrawn

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 ;

Related Conditions & MeSH terms

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

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• Status: Withdrawn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