Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
NCT ID: NCT02981459
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2017-12-08
2018-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mirabegron 25 mg or 50 mg
Mirabegron
daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks
Interventions
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Mirabegron
daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
89 Years
FEMALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
State University of New York at Buffalo
OTHER
Responsible Party
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Tova Ablove
Principal Investigator
Principal Investigators
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Tova S Ablove, MD
Role: PRINCIPAL_INVESTIGATOR
University at Buffalo
Vanessa Barnabei, MD PHD
Role: STUDY_CHAIR
University at Buffalo
Locations
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UBMD Obstetrics and Gynecology
Buffalo, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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030-586061
Identifier Type: -
Identifier Source: org_study_id
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