Urinary Frequency/UrgencyPhase 4NCT02981459

Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women

A Phase 4 study testing Mirabegron in people with Urinary Frequency/Urgency and Bladder Irritable, run by State University of New York at Buffalo at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 89 years, women only
Conditions the study is for: Urinary Frequency/Urgency, Bladder Irritable, Bladder Pain Syndrome
What is being tested?: Mirabegron
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 8 Dec 2017to Jun 2018
Phase: Phase 4
Are there results?: None posted in the registry

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 89 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

English-speaking women
Age: 18 and 89 years
Pain related urinary frequency or urgency associated with >70% of voids. With a minimum of 7 pain motivated voids in 24 hours.
Bladder capacity: > 300 ml
Urinary frequency: 10 or more voids in 24/hours on voiding diary

Who cannot join

Severe Liver disease: Child-Pugh class c
Severe Kidney disease: GFR<30
Elevated blood pressure > 160/95 (in package insert bp >180/110)
Pregnant, will become pregnant, or are nursing during the study
History of recurrent urinary tract infection: 3 or more culture proven urinary tract infections in the past 12 months. An active urinary tract infection.
Tachycardia: pulse > 100, or any other history of arrhythmia

Show all 12Show fewer

Intense urge: bladder volumes of <150 ml on cystometry
Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion
Medications: metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin
Pain medications: no dose changes in narcotic or non-steroidal medications while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.
Neurogenic pain medications such as gabapentin or amitriptyline: no dose changes while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.
Anticholinergic medications for incontinence: no dose changes while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.

Trial locations and contacts

1 site in 1 country.

United States1 site

UBMD Obstetrics and Gynecology
Buffalo, New York, 14222

Other trials in United States

About this study

Official title: Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation

The specific purpose of this study is to provide objective data in prospective open label design (n=40) to support the use of Mirabegron as a treatment for pain related urinary frequency and urgency. Women with bladder pain have a poor response to traditional anticholinergic therapy for their symptoms of frequency and urgency.

Read the detailed description

Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency.

Specific Aims:

To measure the efficacy of Mirabegron in the treatment of frequency and urgency, using voiding diaries.
To measure the number of patients with a 50% or greater reduction in frequency and urgency, using voiding diaries.
To measure the number of patients with a 50% or greater reduction in bladder pain as measured in the O'Leary-Sant (OLS) IC symptom and problem, and the Lowell Parsons Pelvic Pain and Urgency/Frequency (PUF) patient symptom scale.

Intervention/Project goal: Treatment with Mirabegron 25mg for 4 weeks with an option for dose escalation to 50mg. Duration of study 12 weeks.

Inclusion criteria: Women between the ages of 18 and 89 with complaints of pain related urinary frequency are eligible to participate in the study.

Exclusion criteria:

Patients will be excluded from the study if they have:

Severe Liver disease, Child-Pugh class c
Severe Kidney disease, GFR<30
Elevated blood pressure > 160/95 (in package insert bp >180/110)
Urinary retention
Pregnant, will become pregnant, or are nursing
History of recurrent urinary tract infection
Tachycardia: pulse > 100
Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion
Medications - metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin

Conditions: Urinary Frequency/Urgency, Bladder Irritable, Bladder Pain Syndrome
Being tested: Mirabegron
Keywords: bladder pain, urinary frequency, urinary urgency, mirabegron
Medical subject headings: Urinary Bladder, Overactive, 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
daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks

Study groups in NCT02981459
Study group	Role	What they receive
Mirabegron 25 mg or 50 mg	Experimental	Not described Receives: Drug: Mirabegron

What is being measured

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

The number of pain motivated voids per 24 hours.
Measured: 12 weeks

Secondary outcomes (3)

The mean change from baseline to end of study in the daily average number of voids
Measured: 12 weeks
The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ)
Measured: 12 weeks
The mean change in the Patient Perception of Bladder Condition (PPBC)
Measured: 12 weeks

Timeline

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

8 Dec 2017Jun 2018

First posted5 Dec 2016 (estimated)
Study start8 Dec 2017
Primary completionJun 2018 (estimated)
Study completionJun 2018 (estimated)

Why it stopped: Withdrawn by Sponsor

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Urinary Frequency/UrgencyStudies of the same condition, open and under way.
More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02981459
Sponsor's protocol ID: 030-586061
Status last verified: Oct 2020
First submitted: 1 Dec 2016
Last updated: 22 Oct 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Am J Obstet Gynecol. 2002 Jul;187(1):116-26. doi: 10.1067/mob.2002.125704. No abstract available.
PubMed 12114899
Aizawa N, Homma Y, Igawa Y. Effects of mirabegron, a novel beta3-adrenoceptor agonist, on primary bladder afferent activity and bladder microcontractions in rats compared with the effects of oxybutynin. Eur Urol. 2012 Dec;62(6):1165-73. doi: 10.1016/j.eururo.2012.08.056. Epub 2012 Sep 5.
PubMed 22981677
Aizawa N, Igawa Y, Nishizawa O, Wyndaele JJ. Effects of CL316,243, a beta 3-adrenoceptor agonist, and intravesical prostaglandin E2 on the primary bladder afferent activity of the rat. Neurourol Urodyn. 2010 Jun;29(5):771-6. doi: 10.1002/nau.20826.
PubMed 19816919
Geoffrion R; UROGYNAECOLOGY COMMITTEE. Treatments for overactive bladder: focus on pharmacotherapy. J Obstet Gynaecol Can. 2012 Nov;34(11):1092-1101. doi: 10.1016/S1701-2163(16)35440-8.
PubMed 23231848
Hood B, Andersson KE. Common theme for drugs effective in overactive bladder treatment: inhibition of afferent signaling from the bladder. Int J Urol. 2013 Jan;20(1):21-7. doi: 10.1111/j.1442-2042.2012.03196.x. Epub 2012 Oct 17.
PubMed 23072271
Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
PubMed 17049716
Michel MC. beta-Adrenergic Receptor Subtypes in the Urinary Tract. Handb Exp Pharmacol. 2011;(202):307-18. doi: 10.1007/978-3-642-16499-6_15.
PubMed 21290233
Miki T, Matsunami M, Nakamura S, Okada H, Matsuya H, Kawabata A. ONO-8130, a selective prostanoid EP1 receptor antagonist, relieves bladder pain in mice with cyclophosphamide-induced cystitis. Pain. 2011 Jun;152(6):1373-1381. doi: 10.1016/j.pain.2011.02.019. Epub 2011 Mar 10.
PubMed 21396778
Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
PubMed 11412210
Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
PubMed 12811491
Yoshimura N, Seki S, Chancellor MB, de Groat WC, Ueda T. Targeting afferent hyperexcitability for therapy of the painful bladder syndrome. Urology. 2002 May;59(5 Suppl 1):61-7. doi: 10.1016/s0090-4295(01)01639-9.
PubMed 12007524

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Urinary Frequency/Urgency trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation
ClinicalTrials.gov ID: NCT02981459
Acronym / sponsor ID: 030-586061
Conditions: Urinary Frequency/Urgency, Bladder Irritable, Bladder Pain Syndrome
Keywords: bladder pain, urinary frequency, urinary urgency, mirabegron
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Withdrawn by Sponsor
Enrolment: 0 participants (actual)
Lead sponsor: State University of New York at BuffaloUniversity, hospital or other
Collaborators: Astellas Pharma Inc
Study start: 8 Dec 2017 (actual)
Primary completion: Jun 2018 (estimated)
Study completion: Jun 2018 (estimated)
First posted: 5 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency.

Specific Aims:

To measure the efficacy of Mirabegron in the treatment of frequency and urgency, using voiding diaries.
To measure the number of patients with a 50% or greater reduction in frequency and urgency, using voiding diaries.
To measure the number of patients with a 50% or greater reduction in bladder pain as measured in the O'Leary-Sant (OLS) IC symptom and problem, and the Lowell Parsons Pelvic Pain and Urgency/Frequency (PUF) patient symptom scale.

Intervention/Project goal: Treatment with Mirabegron 25mg for 4 weeks with an option for dose escalation to 50mg. Duration of study 12 weeks.

Inclusion criteria: Women between the ages of 18 and 89 with complaints of pain related urinary frequency are eligible to participate in the study.

Exclusion criteria:

Patients will be excluded from the study if they have:

Severe Liver disease, Child-Pugh class c
Severe Kidney disease, GFR<30
Elevated blood pressure > 160/95 (in package insert bp >180/110)
Urinary retention
Pregnant, will become pregnant, or are nursing
History of recurrent urinary tract infection
Tachycardia: pulse > 100
Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion
Medications - metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Mirabegron 25 mg or 50 mg	Experimental	Drug: Mirabegron

Who may qualify

Ages: 18 to 89 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

English-speaking women
Age: 18 and 89 years
Pain related urinary frequency or urgency associated with >70% of voids. With a minimum of 7 pain motivated voids in 24 hours.
Bladder capacity: > 300 ml
Urinary frequency: 10 or more voids in 24/hours on voiding diary

Key exclusion criteria (12 listed)

Severe Liver disease: Child-Pugh class c
Severe Kidney disease: GFR<30
Elevated blood pressure > 160/95 (in package insert bp >180/110)
Pregnant, will become pregnant, or are nursing during the study
History of recurrent urinary tract infection: 3 or more culture proven urinary tract infections in the past 12 months. An active urinary tract infection.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MirabegronAlso: Myrbetriqdaily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks	Drug	Mirabegron 25 mg or 50 mg

Primary outcome

The number of pain motivated voids per 24 hours.
Time frame: 12 weeks

3 secondary outcomes

The mean change from baseline to end of study in the daily average number of voids
Time frame: 12 weeks
The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ)
Time frame: 12 weeks
The mean change in the Patient Perception of Bladder Condition (PPBC)
Time frame: 12 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Background: PubMed 12114899Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Am J Obstet Gynecol. 2002 Jul;187(1):116-26. doi: 10.1067/mob.2002.125704. No abstract available.
Background: PubMed 22981677Aizawa N, Homma Y, Igawa Y. Effects of mirabegron, a novel beta3-adrenoceptor agonist, on primary bladder afferent activity and bladder microcontractions in rats compared with the effects of oxybutynin. Eur Urol. 2012 Dec;62(6):1165-73. doi: 10.1016/j.eururo.2012.08.056. Epub 2012 Sep 5.
Background: PubMed 19816919Aizawa N, Igawa Y, Nishizawa O, Wyndaele JJ. Effects of CL316,243, a beta 3-adrenoceptor agonist, and intravesical prostaglandin E2 on the primary bladder afferent activity of the rat. Neurourol Urodyn. 2010 Jun;29(5):771-6. doi: 10.1002/nau.20826.
Background: PubMed 23231848Geoffrion R; UROGYNAECOLOGY COMMITTEE. Treatments for overactive bladder: focus on pharmacotherapy. J Obstet Gynaecol Can. 2012 Nov;34(11):1092-1101. doi: 10.1016/S1701-2163(16)35440-8.
Background: PubMed 23072271Hood B, Andersson KE. Common theme for drugs effective in overactive bladder treatment: inhibition of afferent signaling from the bladder. Int J Urol. 2013 Jan;20(1):21-7. doi: 10.1111/j.1442-2042.2012.03196.x. Epub 2012 Oct 17.
Background: PubMed 17049716Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
Background: PubMed 21290233Michel MC. beta-Adrenergic Receptor Subtypes in the Urinary Tract. Handb Exp Pharmacol. 2011;(202):307-18. doi: 10.1007/978-3-642-16499-6_15.
Background: PubMed 21396778Miki T, Matsunami M, Nakamura S, Okada H, Matsuya H, Kawabata A. ONO-8130, a selective prostanoid EP1 receptor antagonist, relieves bladder pain in mice with cyclophosphamide-induced cystitis. Pain. 2011 Jun;152(6):1373-1381. doi: 10.1016/j.pain.2011.02.019. Epub 2011 Mar 10.
Background: PubMed 11412210Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001 Jun;87(9):760-6. doi: 10.1046/j.1464-410x.2001.02228.x.
Background: PubMed 12811491Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
Background: PubMed 12007524Yoshimura N, Seki S, Chancellor MB, de Groat WC, Ueda T. Targeting afferent hyperexcitability for therapy of the painful bladder syndrome. Urology. 2002 May;59(5 Suppl 1):61-7. doi: 10.1016/s0090-4295(01)01639-9.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tova S Ablove, MD principal investigator

University at Buffalo

Vanessa Barnabei, MD PHD study chair

University at Buffalo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mirabegron in people with Urinary Frequency/Urgency and Bladder Irritable, run by State University of New York at Buffalo 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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 22 Oct 2020. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

The number of pain motivated voids per 24 hours. (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 NCT02981459, which also lists 11 linked publications.

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 22 Oct 2020.