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

• Status: Withdrawn
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Collaborator: Astellas Pharma Inc
• Treatments: Mirabegron

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.