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

NCT02787083 | Terminated Phase 3 Results

• 1 other identifier: MYRB-15G02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystitis, Interstitial

Keywords

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Interstitial Cystitis Symptom Improvement

  Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire

  12 weeks

Secondary Outcomes (5)

• Number of Participants With Improvement in Incontinence Episodes

  12 weeks

• Impact on Quality of Life

  12 weeks

• Patient Satisfaction

  12 weeks

• Sexual Function

  12 weeks

• Side Effects of Medication

  12 weeks

Study Arms (2)

Mirabegron

EXPERIMENTAL

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

Drug: Mirabegron

Placebo

PLACEBO COMPARATOR

These patients will receive placebo tablets daily for 12 weeks.

Drug: Placebo

Interventions

Mirabegron DRUG

Also known as: Myrbetriq

Mirabegron

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Philadelphia Urosurgical Associates: lead
• Astellas Pharma Global Development, Inc.: collaborator

Study Sites (1)

Philadelphia Urosurgical Associates

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• 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.

  PMID: 32734597 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Kristene E Whitmore MD
• Organization: Philadelphia Urosurgical Associates, PC

bladder1@aol.com

215-704-1457

Study Officials

• Kristene E Whitmore, MD

  Philadelphia Urosurgical Associates

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 1, 2016
• Study Start: August 1, 2016
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2019
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2019-11

Locations

US (1)