Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
Primary Purpose
Urinary Frequency/Urgency, Bladder Irritable, Bladder Pain Syndrome
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mirabegron
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Frequency/Urgency focused on measuring bladder pain, urinary frequency, urinary urgency, mirabegron
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- UBMD Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mirabegron 25 mg or 50 mg
Arm Description
Outcomes
Primary Outcome Measures
The number of pain motivated voids per 24 hours.
Secondary Outcome Measures
The mean change from baseline to end of study in the daily average number of voids
The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ)
The mean change in the Patient Perception of Bladder Condition (PPBC)
Full Information
NCT ID
NCT02981459
First Posted
December 1, 2016
Last Updated
October 19, 2020
Sponsor
State University of New York at Buffalo
Collaborators
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT02981459
Brief Title
Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
Official Title
Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn by Sponsor
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
Astellas Pharma Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency.
Specific Aims:
To measure the efficacy of Mirabegron in the treatment of frequency and urgency, using voiding diaries.
To measure the number of patients with a 50% or greater reduction in frequency and urgency, using voiding diaries.
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:
Severe Liver disease, Child-Pugh class c
Severe Kidney disease, GFR<30
Elevated blood pressure > 160/95 (in package insert bp >180/110)
Urinary retention
Pregnant, will become pregnant, or are nursing
History of recurrent urinary tract infection
Tachycardia: pulse > 100
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Frequency/Urgency, Bladder Irritable, Bladder Pain Syndrome
Keywords
bladder pain, urinary frequency, urinary urgency, mirabegron
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mirabegron 25 mg or 50 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mirabegron
Other Intervention Name(s)
Myrbetriq
Intervention Description
daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks
Primary Outcome Measure Information:
Title
The number of pain motivated voids per 24 hours.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The mean change from baseline to end of study in the daily average number of voids
Time Frame
12 weeks
Title
The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ)
Time Frame
12 weeks
Title
The mean change in the Patient Perception of Bladder Condition (PPBC)
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tova S Ablove, MD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vanessa Barnabei, MD PHD
Organizational Affiliation
University at Buffalo
Official's Role
Study Chair
Facility Information:
Facility Name
UBMD Obstetrics and Gynecology
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12114899
Citation
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Am J Obstet Gynecol. 2002 Jul;187(1):116-26. doi: 10.1067/mob.2002.125704. No abstract available.
Results Reference
background
PubMed Identifier
22981677
Citation
Aizawa N, Homma Y, Igawa Y. Effects of mirabegron, a novel beta3-adrenoceptor agonist, on primary bladder afferent activity and bladder microcontractions in rats compared with the effects of oxybutynin. Eur Urol. 2012 Dec;62(6):1165-73. doi: 10.1016/j.eururo.2012.08.056. Epub 2012 Sep 5.
Results Reference
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PubMed Identifier
19816919
Citation
Aizawa N, Igawa Y, Nishizawa O, Wyndaele JJ. Effects of CL316,243, a beta 3-adrenoceptor agonist, and intravesical prostaglandin E2 on the primary bladder afferent activity of the rat. Neurourol Urodyn. 2010 Jun;29(5):771-6. doi: 10.1002/nau.20826.
Results Reference
background
PubMed Identifier
23231848
Citation
Geoffrion R; UROGYNAECOLOGY COMMITTEE. Treatments for overactive bladder: focus on pharmacotherapy. J Obstet Gynaecol Can. 2012 Nov;34(11):1092-1101. doi: 10.1016/S1701-2163(16)35440-8.
Results Reference
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PubMed Identifier
23072271
Citation
Hood B, Andersson KE. Common theme for drugs effective in overactive bladder treatment: inhibition of afferent signaling from the bladder. Int J Urol. 2013 Jan;20(1):21-7. doi: 10.1111/j.1442-2042.2012.03196.x. Epub 2012 Oct 17.
Results Reference
background
PubMed Identifier
17049716
Citation
Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
Results Reference
background
PubMed Identifier
21290233
Citation
Michel MC. beta-Adrenergic Receptor Subtypes in the Urinary Tract. Handb Exp Pharmacol. 2011;(202):307-18. doi: 10.1007/978-3-642-16499-6_15.
Results Reference
background
PubMed Identifier
21396778
Citation
Miki T, Matsunami M, Nakamura S, Okada H, Matsuya H, Kawabata A. ONO-8130, a selective prostanoid EP1 receptor antagonist, relieves bladder pain in mice with cyclophosphamide-induced cystitis. Pain. 2011 Jun;152(6):1373-1381. doi: 10.1016/j.pain.2011.02.019. Epub 2011 Mar 10.
Results Reference
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PubMed Identifier
11412210
Citation
Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x. Erratum In: BJU Int 2001 Nov;88(7):807.
Results Reference
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PubMed Identifier
12811491
Citation
Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
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Citation
Yoshimura N, Seki S, Chancellor MB, de Groat WC, Ueda T. Targeting afferent hyperexcitability for therapy of the painful bladder syndrome. Urology. 2002 May;59(5 Suppl 1):61-7. doi: 10.1016/s0090-4295(01)01639-9.
Results Reference
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Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
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