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

Withdrawn before enrolling · Phase 4

Conditions studied: Urinary Frequency/Urgency, Bladder Irritable, Bladder Pain Syndrome

In brief

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.

Key facts

Study ID

NCT02981459

Run by

State University of New York at Buffalo

People needed

0

Starts

2017-12-08

Expected to finish

2018-06-01

Last updated by the study team

2020-10-22

Who can join

Age: 18 and older, up to 89. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• English-speaking women
• Age: 18 and 89 years
• Pain related urinary frequency or urgency associated with >70% of voids. With a minimum of 7 pain motivated voids in 24 hours.
• Bladder capacity: > 300 ml
• Urinary frequency: 10 or more voids in 24/hours on voiding diary

You may not qualify if…

• Severe Liver disease: Child-Pugh class c
• Severe Kidney disease: GFR<30
• Elevated blood pressure > 160/95 (in package insert bp >180/110)
• Pregnant, will become pregnant, or are nursing during the study
• History of recurrent urinary tract infection: 3 or more culture proven urinary tract infections in the past 12 months. An active urinary tract infection.
• Tachycardia: pulse > 100, or any other history of arrhythmia
• Intense urge: bladder volumes of <150 ml on cystometry
• Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion
• Medications: metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin
• 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.
• 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.
• 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.

Where it is running

• UBMD Obstetrics and Gynecology — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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