Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-28 @ 11:26 AM
Study NCT ID:
NCT02981459
Status:
WITHDRAWN
Last Update Posted:
2020-10-22
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003556', 'term': 'Cystitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520025', 'term': 'mirabegron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn by Sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2016-12-01', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of pain motivated voids per 24 hours.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'The mean change from baseline to end of study in the daily average number of voids', 'timeFrame': '12 weeks'}, {'measure': 'The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ)', 'timeFrame': '12 weeks'}, {'measure': 'The mean change in the Patient Perception of Bladder Condition (PPBC)', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bladder pain', 'urinary frequency', 'urinary urgency', 'mirabegron'], 'conditions': ['Urinary Frequency/Urgency', 'Bladder Irritable', 'Bladder Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '12114899', 'type': 'BACKGROUND', '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.'}, {'pmid': '22981677', 'type': 'BACKGROUND', '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.'}, {'pmid': '19816919', 'type': 'BACKGROUND', '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.'}, {'pmid': '23231848', 'type': 'BACKGROUND', '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.'}, {'pmid': '23072271', 'type': 'BACKGROUND', '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.'}, {'pmid': '17049716', 'type': 'BACKGROUND', '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.'}, {'pmid': '21290233', 'type': 'BACKGROUND', '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.'}, {'pmid': '21396778', 'type': 'BACKGROUND', '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.'}, {'pmid': '11412210', 'type': 'BACKGROUND', '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.'}, {'pmid': '12811491', 'type': 'BACKGROUND', '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.'}, {'pmid': '12007524', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency.\n\nSpecific Aims:\n\n1. To measure the efficacy of Mirabegron in the treatment of frequency and urgency, using voiding diaries.\n2. To measure the number of patients with a 50% or greater reduction in frequency and urgency, using voiding diaries.\n3. 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.\n\nIntervention/Project goal: Treatment with Mirabegron 25mg for 4 weeks with an option for dose escalation to 50mg. Duration of study 12 weeks.\n\nInclusion criteria: Women between the ages of 18 and 89 with complaints of pain related urinary frequency are eligible to participate in the study.\n\nExclusion criteria:\n\nPatients will be excluded from the study if they have:\n\n1. Severe Liver disease, Child-Pugh class c\n2. Severe Kidney disease, GFR\\<30\n3. Elevated blood pressure \\> 160/95 (in package insert bp \\>180/110)\n4. Urinary retention\n5. Pregnant, will become pregnant, or are nursing\n6. History of recurrent urinary tract infection\n7. Tachycardia: pulse \\> 100\n8. Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion\n9. Medications - metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. English-speaking women\n2. Age: 18 and 89 years\n3. Pain related urinary frequency or urgency associated with \\>70% of voids. With a minimum of 7 pain motivated voids in 24 hours.\n4. Bladder capacity: \\> 300 ml\n5. Urinary frequency: 10 or more voids in 24/hours on voiding diary\n\nExclusion Criteria:\n\n1. Severe Liver disease: Child-Pugh class c\n2. Severe Kidney disease: GFR\\<30\n3. Elevated blood pressure \\> 160/95 (in package insert bp \\>180/110)\n4. Pregnant, will become pregnant, or are nursing during the study\n5. History of recurrent urinary tract infection: 3 or more culture proven urinary tract infections in the past 12 months. An active urinary tract infection.\n6. Tachycardia: pulse \\> 100, or any other history of arrhythmia\n7. Intense urge: bladder volumes of \\<150 ml on cystometry\n8. Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion\n9. Medications: metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin\n10. 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.\n11. 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.\n12. 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.'}, 'identificationModule': {'nctId': 'NCT02981459', 'briefTitle': 'Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation', 'orgStudyIdInfo': {'id': '030-586061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirabegron 25 mg or 50 mg', 'interventionNames': ['Drug: Mirabegron']}], 'interventions': [{'name': 'Mirabegron', 'type': 'DRUG', 'otherNames': ['Myrbetriq'], 'description': 'daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks', 'armGroupLabels': ['Mirabegron 25 mg or 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'UBMD Obstetrics and Gynecology', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Tova S Ablove, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}, {'name': 'Vanessa Barnabei, MD PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tova Ablove', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}