Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02981459
Other study ID # 030-586061
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date December 8, 2017
Est. completion date June 2018

Study information

Verified date October 2020
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. 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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 89 Years
Eligibility 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. 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.

Study Design


Intervention

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

Locations

Country Name City State
United States UBMD Obstetrics and Gynecology Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
State University of New York at Buffalo Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Aizawa N, Homma Y, Igawa Y. Effects of mirabegron, a novel ß3-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. — View 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. — View 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. — View 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. Review. — View 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. Epub 2006 Oct 2. — View Citation

Michel MC. ß-Adrenergic Receptor Subtypes in the Urinary Tract. Handb Exp Pharmacol. 2011;(202):307-18. doi: 10.1007/978-3-642-16499-6_15. Review. — View 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):1373-81. doi: 10.1016/j.pain.2011.02.019. Epub 2011 Mar 10. — View Citation

Milsom I, Abrams P, Cardozo L, Roberts RG, Thüroff 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. Erratum in: BJU Int 2001 Nov;88(7):807. — View 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. Epub 2002 Nov 15. — View 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The number of pain motivated voids per 24 hours. 12 weeks
Secondary The mean change from baseline to end of study in the daily average number of voids 12 weeks
Secondary The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ) 12 weeks
Secondary The mean change in the Patient Perception of Bladder Condition (PPBC) 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT04313972 - IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone Phase 4
Completed NCT03282318 - A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis Phase 2
Terminated NCT02591199 - Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Phase 2
Completed NCT04401176 - Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome Phase 2
Completed NCT04001244 - Translational Research in Pelvic Pain
Suspended NCT04450316 - Low-dose Naltrexone for Bladder Pain Syndrome Phase 2
Completed NCT04010513 - Hypnosis for Bladder Pain Syndrome N/A
Recruiting NCT05518864 - GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis (GETSBI Study) Phase 4
Active, not recruiting NCT05414305 - The Female Microbiome in Patients Undergoing Bladder Instillation Therapy Phase 2
Withdrawn NCT03027076 - Microbiome of Urologic Chronic Pelvic Pain Syndrome N/A
Terminated NCT01879930 - Chronic Bladder Pain Syndrome in Women: Can Doxycycline Help? A Prospective Study Phase 4
Recruiting NCT05155384 - Biopsychosocial and Conventional Approach in Bladder Pain Syndrome N/A
Recruiting NCT05737121 - Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS Phase 2
Recruiting NCT05699551 - Supervised Exercise as a Therapeutic Strategy for Interstitial Cystitis/Bladder Pain Syndrome N/A
Recruiting NCT06299683 - Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment N/A
Completed NCT04821882 - Intravesical Injection of Dextrose to Improve Lower Urinary Tract Symptoms Caused by Chronic Cystitis N/A
Completed NCT04208087 - PK and Safety of SI-722 in IC/BPS Phase 1/Phase 2
Recruiting NCT05740007 - A Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Phase 2
Recruiting NCT03076762 - Comparative Study Suburothelial and Trigonal Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Phase 2
Active, not recruiting NCT04789135 - Evaluation of Response to Use of Intravesical Ozone Gas in Interstitial Cystitis /Bladder Pain Syndrome Phase 2