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Mirabegron and Urinary Urgency Incontinence

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ClinicalTrials.gov Identifier: NCT02495389
Recruitment Status : Recruiting
First Posted : July 13, 2015
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Alan J. Wolfe, Loyola University

Brief Summary:
This study is for women diagnosed with urgency incontinence or overactive bladder (OAB). Some patients continue to have symptoms even while taking medication for OAB. The purpose of this study is to see if women who respond to a medication called mirabegron have different bladder bacteria than women who do not respond.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: mirabegron Phase 4

Detailed Description:

Mirabegron is an FDA-approved medication for urgency incontinence. Evaluation of mirabegron's influence on clinical symptoms should take into account the effect of the female urinary microbiome (FUM) on patient response to treatment. Several bacterial species are more common in overactive bladder patients than in asymptomatic controls.

Currently, physicians have limited ability to personalize urinary urgency incontinence treatment, and thus the prescribed medication may provide minimal symptom relief for some patients. Since the FUM can be assessed prior to treatment, this study proposes to determine if baseline FUM assessment can provide insight into future symptoms relief with mirabegron treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome
Study Start Date : January 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Arm Intervention/treatment
mirabegron
All study participants will receive 25 mg mirabegron (Myrbetriq) to be taken by mouth once a day for 12 weeks. If after 4 weeks symptoms are not adequately improving, participants will have the option of increasing mirabegron dose to 50 mg per day for the remaining 8 weeks.
Drug: mirabegron
All study participants will be given mirabegron, 25 mg by mouth once a day for 12 weeks.
Other Name: Myrbetriq




Primary Outcome Measures :
  1. Patient Perception of Bladder Control (PPBC) [ Time Frame: 12 weeks ]
    Self-report measure in which patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 (no problems at all) to 6 (many severe problems)


Secondary Outcome Measures :
  1. Overactive Bladder Questionnaire (OAB-q) [ Time Frame: 12 weeks ]
    Self-report measure in which patients are asked to rate how much they have been bothered by bladder symptoms on a scale of 1 (not at all) to 6 (a very great deal). Patients are also asked to rate how much symptoms have affected their life on a scale of 1 (none of the time) to 6 (all of the time).

  2. Urinary Distress Inventory (UDI-6) [ Time Frame: 12 weeks ]
    Self-report measure in which patients are asked to rate how much they are bothered by symptoms of urinary urgency on a scale from 1(not at all) to 4 (quite a bit)

  3. Pelvic Floor Distress Inventory (PFDI) [ Time Frame: 12 weeks ]
    Self-report measure in which patients are asked to rate how much they are bothered by pelvic area symptoms on a scale from 1 (not at all) to 4 (quite a bit).

  4. Patient Global Impression of Severity (PGI-S) [ Time Frame: 12 weeks ]
    Self-report measure in which patients are asked to rate their urinary tract condition on a scale from 1 (normal) to 4 (severe).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bothersome idiopathic (non-neurologic) urgency urinary incontinence (UUI) who recall ≥ 5 urgency predominant urinary incontinence episodes in the prior week (urgency urinary incontinence or mixed urinary incontinence-urgency predominant)
  • No contraindications to taking mirabegron
  • Patients on current OAB therapy will undergo a two-week drug washout period prior to baseline assessment

Exclusion Criteria:

  • Neurologic disease known to affect the lower urinary tract
  • Systemic immunologic deficiency
  • Current urinary tract infection (UTI) (based on dipstick assessment) or recurrent culture-proven UTIs
  • History or current pelvic malignancy or radiation
  • Untreated symptomatic pelvic organ prolapse (POP) > POP-Q Stage II
  • A contraindication to receiving mirabegron
  • Women of childbearing potential who are pregnant or nursing or intend to become pregnant during the study, or who are not practicing a reliable method of contraception
  • Must not have taken any antibiotics, for any reason, in the 4 weeks prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495389


Contacts
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Contact: Alan Wolfe, PhD 708-216-5814 awolfe@luc.edu

Locations
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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Alan Wolfe, PhD    708-216-5814    awolfe@luc.edu   
Sponsors and Collaborators
Loyola University
Astellas Pharma US, Inc.
Investigators
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Principal Investigator: Alan Wolfe, PhD Loyola Univerity Medical Center

Publications:
Hartmann, K.E., McPheeters, M.L., Biller, D.H., Ward, R.M., McKoy, J.N., Jerome, R.N., Micucci, S.R., Meints, L., Fisher, J.A., Scott, T.A., et al. (2009). Treatment of overactive bladder in women. Evid Rep Technol Assess (Full Rep), 1-120, v. Haylen, B.T., de Ridder, D., Freeman, R.M., Swift, S.E., Berghmans, B., Lee, J., Monga, A., Petri, E., Rizk, D.E., Sand, P.K., et al. (2010a). An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J 21, 5-26.

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Responsible Party: Alan J. Wolfe, Professor, Loyola University
ClinicalTrials.gov Identifier: NCT02495389     History of Changes
Other Study ID Numbers: 207102
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

Keywords provided by Alan J. Wolfe, Loyola University:
urinary urgency incontinence

Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents