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

October 19, 2020 updated by: Tova Ablove, State University of New York at Buffalo

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14222
        • UBMD Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirabegron 25 mg or 50 mg
Drug: Mirabegron
daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks
Other Names:
  • Myrbetriq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of pain motivated voids per 24 hours.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The mean change from baseline to end of study in the daily average number of voids
Time Frame: 12 weeks
12 weeks
The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ)
Time Frame: 12 weeks
12 weeks
The mean change in the Patient Perception of Bladder Condition (PPBC)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: Tova S Ablove, MD, University at Buffalo
  • Study Chair: Vanessa Barnabei, MD PHD, University at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 030-586061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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