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Cystitis, InterstitialPhase 3MirabegronICNCT02787083

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

A Phase 3 study testing Mirabegron in people with Cystitis, Interstitial, run by Philadelphia Urosurgical Associates at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 95 years, women only
Conditions the study is for
Cystitis, Interstitial
What is being tested?
Mirabegron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
1 siteUnited States
Study dates
Aug 2016to 5 Jul 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Philadelphia Urosurgical Associates

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

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.

Being tested
Mirabegron, Placebo
Keywords
Interstitial Cystitis
Medical subject headings
Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirabegronDrug

    Also called Myrbetriq

  • PlaceboDrug

Study groups in NCT02787083
Study groupRoleWhat they receive
MirabegronExperimentalThese patients will receive mirabegron 50mg tablets daily for 12 weeks.
Receives: Drug: Mirabegron
PlaceboPlacebo comparatorThese patients will receive placebo tablets daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Interstitial Cystitis Symptom Improvement

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

    Measured: 12 weeks

Secondary outcomes (5)

  1. Number of Participants With Improvement in Incontinence Episodes

    Evaluate incontinence episodes via bladder diary and UDI-6 questionnaire

    Measured: 12 weeks

  2. Impact on Quality of Life

    Evaluate impact on quality of life from bladder, bowel and vaginal/pelvic symptoms via PFIQ-7 questionnaire

    Measured: 12 weeks

  3. Patient Satisfaction

    evaluate participant satisfaction with treatment/placebo via Global response assessment form

    Measured: 12 weeks

  4. Sexual Function

    Evaluate changes in sexual function via FSFI questionnaire

    Measured: 12 weeks

  5. Side Effects of Medication

    Will assess if participants have side effects of medication via office visits

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion5 Jul 2019
  4. Study completion5 Jul 2019

Why it stopped: Low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02787083
Sponsor's protocol ID
MYRB-15G02
Acronym
MirabegronIC
Status last verified
Nov 2019
First submitted
23 May 2016
Last updated
3 Dec 2019
Data monitoring committee
No
Individual data sharing
Undecided

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(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.

    PubMed 32734597

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirabegron in people with Cystitis, Interstitial, run by Philadelphia Urosurgical Associates at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Interstitial Cystitis Symptom Improvement (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02787083, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.

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