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

NCT02981459 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 030-586061
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Frequency/Urgency; Bladder Irritable; Bladder Pain Syndrome

Keywords

bladder pain; urinary frequency; urinary urgency; mirabegron

Outcome Measures

Primary Outcomes (1)

• The number of pain motivated voids per 24 hours.

  12 weeks

Secondary Outcomes (3)

• The mean change from baseline to end of study in the daily average number of voids

  12 weeks

• The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ)

  12 weeks

• The mean change in the Patient Perception of Bladder Condition (PPBC)

  12 weeks

Study Arms (1)

Mirabegron 25 mg or 50 mg

EXPERIMENTAL

Drug: Mirabegron

Interventions

Mirabegron DRUG

daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks

Also known as: Myrbetriq

Mirabegron 25 mg or 50 mg

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

UBMD Obstetrics and Gynecology

Buffalo, New York, 14222, United States

Location

Related Publications (11)

• 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: 12114899 BACKGROUND

• 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: 22981677 BACKGROUND

• 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: 19816919 BACKGROUND

• 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: 23231848 BACKGROUND

• 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: 23072271 BACKGROUND

• 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: 17049716 BACKGROUND

• 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: 21290233 BACKGROUND

• 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: 21396778 BACKGROUND

• 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: 11412210 BACKGROUND

• 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: 12811491 BACKGROUND

• 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.

  PMID: 12007524 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Cystitis, Interstitial

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cystitis

Study Officials

• Tova S Ablove, MD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Vanessa Barnabei, MD PHD

  University at Buffalo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: December 8, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)