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

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