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

This study is not yet open for participant recruitment.
Verified November 2016 by State University of New York at Buffalo
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981459
First Posted: December 5, 2016
Last Update Posted: December 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
State University of New York at Buffalo
  Purpose
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.

Condition Intervention Phase
Urinary Frequency/Urgency Bladder Irritable Bladder Pain Syndrome Drug: Mirabegron Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • The number of pain motivated voids per 24 hours. [ Time Frame: 12 weeks ]

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

Estimated Enrollment: 40
Study Start Date: January 2017
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Myrbetriq

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. Medications - metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. Medications: metoprolol, desiparmine, digoxin, propafenone, thioridazine, flecainide, warfarin
  9. 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.
  10. 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.
  11. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981459


Contacts
Contact: Tova S Ablove, MD 716-878-7138 tablove@buffalo.edu
Contact: Rachel Shepherd, RN 716-878-7315 rlaporta@buffalo.edu

Locations
United States, New York
UBMD Obstetrics and Gynecology Not yet recruiting
Buffalo, New York, United States, 14222
Contact: Tova S Ablove, MD    716-878-7138    tablove@buffalo.edu   
Contact: Rachel Shephard, RN    716-878-7315    rlaporta@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
Astellas Pharma Inc
Investigators
Principal Investigator: Tova S Ablove, MD University at Buffalo
Study Chair: Vanessa Barnabei, MD PHD University at Buffalo
  More Information

Publications:

Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT02981459     History of Changes
Other Study ID Numbers: 030-586061
First Submitted: December 1, 2016
First Posted: December 5, 2016
Last Update Posted: December 6, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by State University of New York at Buffalo:
bladder pain
urinary frequency
urinary urgency
mirabegron

Additional relevant MeSH terms:
Polyuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents