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

Last updated: November 13, 2019
Sponsor: Philadelphia Urosurgical Associates
Overall Status: Terminated

Phase

3

Condition

Urinary Tract Infections

Urinary Incontinence

Bladder Disorders

Treatment

N/A

Clinical Study ID

NCT02787083
MYRB-15G02
  • Ages 18-95
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be diagnosed with BPS/IC with a minimum O'Leary-Sant score of 8 onthe ICSI, as well as 8 on the ICPI. Participants should be stable on their regimen (noincrease or change in medications, behavioral treatments or physical therapy inprevious 4 weeks prior to starting the study) and be willing to remain on this regimenduring the duration of the study.

  2. Participant must be stable on current IC/BPS regimen.

  3. Participant must have subjective complaints of i. urinary urgency, relieved with voiding or ii. urinary frequency; ≥ 8 voids per dayiii. pelvic pain, pressure, hypersensitivity or discomfort

  4. Gender of subjects: Participants in this study will be female. Pregnant women andbreastfeeding women will be excluded due to unknown risk of study medication onpregnancy and fetus or nursing infants.

  5. Age of subjects: Age of participants will range from 18 to 95 years.

  6. Racial and ethnic origin: There are no enrollment restrictions based upon race orethnic origin. The racial and ethnic distribution of participants is entirely based onthe population of patients at the study site.

  7. Other inclusion criteria:

  8. Participant must give written informed consent to participate in the study

  9. Participant must be able to make decisions for herself

  10. Participant must have a negative urine dip within 7 days prior to start of thestudy

  11. Female participants who are of childbearing age and sexually active with men mustagree to use a medically acceptable method of contraception throughout the studyperiod, and for 7 days after the study period. Medically acceptable methods ofcontraception include abstinence, oral contraceptive pills, hormonalcontraceptive patches, diaphragm with or without spermicide, IUD, condoms, depotmedroxyprogesterone acetate, subdermal progestin implants, vasectomized partner,or status post surgical sterilization.

Exclusion

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 priorto the start of the study

  4. Participant is an employee of Astellas, or any other pharmaceutical company or thePelvic and Sexual Health Institute

  5. Participant is currently in another pharmaceutical trial

  6. Participant has used anticholinergic medications, tamsulosin or opioid narcaroticmedication 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 flaresincluding non-opioid narcotics, non-steroidal anti-inflammatory agents, pyridium anduribel.

  7. Participant has had bladder hydrodistention or bladder instillations within the last 4weeks. Participants may have bladder instillations during the study period ifnecessary 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 studyperiod

  9. Participant has used warfarin or digoxin within the last 7 days prior to the study orduring the study period

  10. Participant has used cyclosporine within the 7 days prior to the study or during thestudy period

  11. Participant has an active S3 nerve stimulator implanted or has had PTNS within 6months prior to starting the study

  12. Participant has not had intravesical botulinum toxin injection in 6 months prior tostarting 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 weeksprior 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 orC)

  18. Participant has urinary retention defined as greater than 150cc post-void residual asdiagnosed by catheterization, bladder ultrasound scan or urodynamic testing within thelast 14 days.

  19. Participant has history of severe uncontrolled blood pressure (defines as systolicgreater than or equal to 180mm Hg and/or diastolic blood pressure greater than orequal to 110 mm Hg)

  20. Participant has a neurological disease including, but not limited to, multiplesclerosis, 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 inactiveingredients in the supplied form of mirabegron

Study Design

Total Participants: 9
Study Start date:
August 01, 2016
Estimated Completion Date:
July 05, 2019

Connect with a study center

  • Philadelphia Urosurgical Associates

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

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