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

Primary Purpose

Cystitis, Interstitial

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mirabegron
Placebo
Sponsored by
Philadelphia Urosurgical Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystitis, Interstitial focused on measuring Interstitial Cystitis

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Philadelphia Urosurgical Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mirabegron

Placebo

Arm Description

These patients will receive mirabegron 50mg tablets daily for 12 weeks.

These patients will receive placebo tablets daily for 12 weeks.

Outcomes

Primary Outcome Measures

Number of Participants With Interstitial Cystitis Symptom Improvement
Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire

Secondary Outcome Measures

Number of Participants With Improvement in Incontinence Episodes
Evaluate incontinence episodes via bladder diary and UDI-6 questionnaire
Impact on Quality of Life
Evaluate impact on quality of life from bladder, bowel and vaginal/pelvic symptoms via PFIQ-7 questionnaire
Patient Satisfaction
evaluate participant satisfaction with treatment/placebo via Global response assessment form
Sexual Function
Evaluate changes in sexual function via FSFI questionnaire
Side Effects of Medication
Will assess if participants have side effects of medication via office visits

Full Information

First Posted
May 23, 2016
Last Updated
November 13, 2019
Sponsor
Philadelphia Urosurgical Associates
Collaborators
Astellas Pharma Global Development, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02787083
Brief Title
A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis
Acronym
MirabegronIC
Official Title
A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 5, 2019 (Actual)
Study Completion Date
July 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philadelphia Urosurgical Associates
Collaborators
Astellas Pharma Global Development, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial
Keywords
Interstitial Cystitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirabegron
Arm Type
Experimental
Arm Description
These patients will receive mirabegron 50mg tablets daily for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
These patients will receive placebo tablets daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Mirabegron
Other Intervention Name(s)
Myrbetriq
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Interstitial Cystitis Symptom Improvement
Description
Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Improvement in Incontinence Episodes
Description
Evaluate incontinence episodes via bladder diary and UDI-6 questionnaire
Time Frame
12 weeks
Title
Impact on Quality of Life
Description
Evaluate impact on quality of life from bladder, bowel and vaginal/pelvic symptoms via PFIQ-7 questionnaire
Time Frame
12 weeks
Title
Patient Satisfaction
Description
evaluate participant satisfaction with treatment/placebo via Global response assessment form
Time Frame
12 weeks
Title
Sexual Function
Description
Evaluate changes in sexual function via FSFI questionnaire
Time Frame
12 weeks
Title
Side Effects of Medication
Description
Will assess if participants have side effects of medication via office visits
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Participant must be stable on current IC/BPS regimen. 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 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. Age of subjects: Age of participants will range from 18 to 95 years. 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. Other inclusion criteria: Participant must give written informed consent to participate in the study Participant must be able to make decisions for herself Participant must have a negative urine dip within 7 days prior to start of the study 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: Participant is currently pregnant or breastfeeding Participant has a positive urinary pregnancy test at the time of screening Participant is currently or has been on antibiotic therapy with the last 7 days prior to the start of the study Participant is an employee of Astellas, or any other pharmaceutical company or the Pelvic and Sexual Health Institute Participant is currently in another pharmaceutical trial 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. 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. 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 Participant has used warfarin or digoxin within the last 7 days prior to the study or during the study period Participant has used cyclosporine within the 7 days prior to the study or during the study period Participant has an active S3 nerve stimulator implanted or has had PTNS within 6 months prior to starting the study Participant has not had intravesical botulinum toxin injection in 6 months prior to starting the study Participant has grade III or IV pelvic organ prolapse Participant has been diagnosed with a urinary tract infection within the last 4 weeks prior to starting the study Participant has history of bladder cancer Participant is currently an alcohol or substance abuser, or is a chronic opioid user Participant has history of renal failure (GFR <30) or liver failure (CHILD score B or C) 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. 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) 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 Participant has urinary frequency of less than 8 times/day Participant has bladder or lower ureteral calculi Participant has active genital herpes Participant has urethral diverticulum Participant has chemical cystitis Participant has radiation or tuberculosis cystitis Participant has known hypersensitivity to mirabegron or any of the inactive ingredients in the supplied form of mirabegron
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristene E Whitmore, MD
Organizational Affiliation
Philadelphia Urosurgical Associates
Official's Role
Study Director
Facility Information:
Facility Name
Philadelphia Urosurgical Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32734597
Citation
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(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
Results Reference
derived

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

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