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NCT Number: NCT02495389

Mirabegron and Urinary Urgency Incontinence

This study is for women diagnosed with urinary urgency incontinence (UUI) or overactive bladder (OAB). Some patients continue to have symptoms even while taking medication for OAB. The purpose of this study is to estimate the number of women who respond to a medication called mirabegron and estimate change in symptom severity over 12 weeks of therapy. A secondary goal is to correlate the female urinary microbiome (FUM) with response to treatment and change in symptom severity over 12 weeks of therapy.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 in the 4 weeks prior to enrollment

Treatment and study plan

Mirabegron

Drug

Mirabegron is a medication for the treatment of overactive bladder. It was developed by Astellas Pharma and was approved by the United States Food and Drug Administration (FDA) in July 2012.

Other names: Myrbetriq, Betmiga

Primary outcomes

  1. Response to Therapy

    Time frame: 12 weeks

    Response to therapy was measured using the Patient Perception of Bladder Control (PPBC) questionnaire which measures patients' perceived bladder condition on a 6-point ordinal scale ranging from 1 (no problems at all) to 6 (many severe problems). Women reporting a PPBC score of 4 or 5 by week 12 responded to therapy. Women reporting a PPBC score of 1, 2, or 3 by week 12 did not respond to therapy.

Secondary outcomes

  1. Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)

    Time frame: 12 weeks

    The Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) score is a measure of patients' bladder symptom severity. It ranges from 25 to 150 where higher scores indicate greater quality of life.

  2. Change in Urinary Distress Inventory (UDI)

    Time frame: 12 weeks

    The Urinary Distress Inventory is a 29-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity.

  3. Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score

    Time frame: 12 weeks

    The Pelvic Organ Prolapse Distress Inventory (POPDI) is a 16-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity.

  4. Change in Colo-Rectal-Anal Distress Inventory (CRADI)

    Time frame: 12 weeks

    The Colo-Rectal-Anal Distress Inventory (CRADI) is a 17-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 400 where higher scores indicate worsening symptom severity.

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Collaborators

  • Astellas Pharma US, Inc.

Registry information

Official study title

Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 13, 2015
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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