Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis (MirabegronIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787083
Recruitment Status : Terminated (Low enrollment)
First Posted : June 1, 2016
Results First Posted : December 3, 2019
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Kristene Whitmore, Philadelphia Urosurgical Associates

Tracking Information
First Submitted Date  ICMJE May 23, 2016
First Posted Date  ICMJE June 1, 2016
Results First Submitted Date  ICMJE October 3, 2019
Results First Posted Date  ICMJE December 3, 2019
Last Update Posted Date December 3, 2019
Study Start Date  ICMJE August 2016
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
Number of Participants With Interstitial Cystitis Symptom Improvement [ Time Frame: 12 weeks ]
Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2016)
Interstitial Cystitis Symptom Improvement [ Time Frame: 12 weeks ]
Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • Number of Participants With Improvement in Incontinence Episodes [ Time Frame: 12 weeks ]
    Evaluate incontinence episodes via bladder diary and UDI-6 questionnaire
  • Impact on Quality of Life [ Time Frame: 12 weeks ]
    Evaluate impact on quality of life from bladder, bowel and vaginal/pelvic symptoms via PFIQ-7 questionnaire
  • Patient Satisfaction [ Time Frame: 12 weeks ]
    evaluate participant satisfaction with treatment/placebo via Global response assessment form
  • Sexual Function [ Time Frame: 12 weeks ]
    Evaluate changes in sexual function via FSFI questionnaire
  • Side Effects of Medication [ Time Frame: 12 weeks ]
    Will assess if participants have side effects of medication via office visits
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2016)
  • Incontinence Measure [ Time Frame: 12 weeks ]
    Evaluate incontinence episodes via bladder diary and UDI-6 questionnaire
  • Impact on Quality of Life [ Time Frame: 12 weeks ]
    Evaluate impact on quality of life from bladder, bowel and vaginal/pelvic symptoms via PFIQ-7 questionnaire
  • Patient Satisfaction [ Time Frame: 12 weeks ]
    evaluate participant satisfaction with treatment/placebo via Global response assessment form
  • Sexual Function [ Time Frame: 12 weeks ]
    Evaluate changes in sexual function via FSFI questionnaire
  • Side Effects of Medication [ Time Frame: 12 weeks ]
    Will assess if participants have side effects of medication via office visits
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis
Official Title  ICMJE A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis
Brief Summary Bladder pain syndrome/interstitial cystitis (BPS/IC) is a difficult disease to both diagnose and treat. It is defined as an unpleasant sensation (pain, pressure, or discomfort) perceived to be related to the urinary bladder and associated with lower urinary tract symptoms for at least 6 weeks duration, in the absence of infection or other identifiable causes. Pain is the universal symptom, but many also experience symptoms of overactive bladder, possibly directly related to the mechanism of pain. Treating pain may influence the symptom of urgency, if the urge arises from a need to alleviate pain. In some patients whose pain improves with treatment, troubling overactive bladder symptoms still remain. Beta-3 adrenergic agonists have been found to decrease signaling of C-fibers in animal models. So, the investigators hypothesize that mirabegron, which is FDA-approved for treatment of overactive bladder, would also improve symptoms in patients with BPS/IC. As a selective beta-3 agonist, mirabegron acts on the beta-3 receptors found in the bladder which mediate relaxation of the detrusor muscle. It has been shown to significantly decrease the number or micturition episodes, urgency episodes, and increased mean volume of urine voided per micturition. It also has a favorable tolerability profile.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Cystitis, Interstitial
Intervention  ICMJE
  • Drug: Mirabegron
    Other Name: Myrbetriq
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Mirabegron
    These patients will receive mirabegron 50mg tablets daily for 12 weeks.
    Intervention: Drug: Mirabegron
  • Placebo Comparator: Placebo
    These patients will receive placebo tablets daily for 12 weeks.
    Intervention: Drug: Placebo
Publications * Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7:CD013325. doi: 10.1002/14651858.CD013325.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 1, 2019)
9
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2016)
60
Actual Study Completion Date  ICMJE July 5, 2019
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participants must be diagnosed with BPS/IC with a minimum O'Leary-Sant score of 8 on the ICSI, as well as 8 on the ICPI. Participants should be stable on their regimen (no increase or change in medications, behavioral treatments or physical therapy in previous 4 weeks prior to starting the study) and be willing to remain on this regimen during the duration of the study.

    1. Participant must be stable on current IC/BPS regimen.
    2. Participant must have subjective complaints of

    i. urinary urgency, relieved with voiding or ii. urinary frequency; ≥ 8 voids per day iii. pelvic pain, pressure, hypersensitivity or discomfort

  2. Gender of subjects: Participants in this study will be female. Pregnant women and breastfeeding women will be excluded due to unknown risk of study medication on pregnancy and fetus or nursing infants.
  3. Age of subjects: Age of participants will range from 18 to 95 years.
  4. Racial and ethnic origin: There are no enrollment restrictions based upon race or ethnic origin. The racial and ethnic distribution of participants is entirely based on the population of patients at the study site.
  5. Other inclusion criteria:

    1. Participant must give written informed consent to participate in the study
    2. Participant must be able to make decisions for herself
    3. Participant must have a negative urine dip within 7 days prior to start of the study
    4. Female participants who are of childbearing age and sexually active with men must agree to use a medically acceptable method of contraception throughout the study period, and for 7 days after the study period. Medically acceptable methods of contraception include abstinence, oral contraceptive pills, hormonal contraceptive patches, diaphragm with or without spermicide, IUD, condoms, depot medroxyprogesterone acetate, subdermal progestin implants, vasectomized partner, or status post surgical sterilization.

Exclusion Criteria:

To participate in the study subjects must not meet any of the following criteria:

  1. Participant is currently pregnant or breastfeeding
  2. Participant has a positive urinary pregnancy test at the time of screening
  3. Participant is currently or has been on antibiotic therapy with the last 7 days prior to the start of the study
  4. Participant is an employee of Astellas, or any other pharmaceutical company or the Pelvic and Sexual Health Institute
  5. Participant is currently in another pharmaceutical trial
  6. Participant has used anticholinergic medications, tamsulosin or opioid narcarotic medication within the last 30 days prior to the study or during the study period. Participants will be able to use rescue medications for BPS/IC symptom flares including non-opioid narcotics, non-steroidal anti-inflammatory agents, pyridium and uribel.
  7. Participant has had bladder hydrodistention or bladder instillations within the last 4 weeks. Participants may have bladder instillations during the study period if necessary for rescue from symptom flares.
  8. Participant has used or currently using CYP2D6 substrates, such as thioridazine, flecainide, propafenone, within the last 7 days prior to the study or during study period
  9. Participant has used warfarin or digoxin within the last 7 days prior to the study or during the study period
  10. Participant has used cyclosporine within the 7 days prior to the study or during the study period
  11. Participant has an active S3 nerve stimulator implanted or has had PTNS within 6 months prior to starting the study
  12. Participant has not had intravesical botulinum toxin injection in 6 months prior to starting the study
  13. Participant has grade III or IV pelvic organ prolapse
  14. Participant has been diagnosed with a urinary tract infection within the last 4 weeks prior to starting the study
  15. Participant has history of bladder cancer
  16. Participant is currently an alcohol or substance abuser, or is a chronic opioid user
  17. Participant has history of renal failure (GFR <30) or liver failure (CHILD score B or C)
  18. Participant has urinary retention defined as greater than 150cc post-void residual as diagnosed by catheterization, bladder ultrasound scan or urodynamic testing within the last 14 days.
  19. Participant has history of severe uncontrolled blood pressure (defines as systolic greater than or equal to 180mm Hg and/or diastolic blood pressure greater than or equal to 110 mm Hg)
  20. Participant has a neurological disease including, but not limited to, multiple sclerosis, Parkinson's disease, Alzheimer's disease, spinal cord injury, brain injury, stroke or dementia
  21. Participant has urinary frequency of less than 8 times/day
  22. Participant has bladder or lower ureteral calculi
  23. Participant has active genital herpes
  24. Participant has urethral diverticulum
  25. Participant has chemical cystitis
  26. Participant has radiation or tuberculosis cystitis
  27. Participant has known hypersensitivity to mirabegron or any of the inactive ingredients in the supplied form of mirabegron
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787083
Other Study ID Numbers  ICMJE MYRB-15G02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kristene Whitmore, Philadelphia Urosurgical Associates
Study Sponsor  ICMJE Philadelphia Urosurgical Associates
Collaborators  ICMJE Astellas Pharma Global Development, Inc.
Investigators  ICMJE
Study Director: Kristene E Whitmore, MD Philadelphia Urosurgical Associates
PRS Account Philadelphia Urosurgical Associates
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP