Clinical trial NCT02495389: Mirabegron and Urinary Urgency Incontinence
Official title: Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Urinary Urgency Incontinence
Mirabegron
Myrbetriq
Betmiga
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2015-07-13
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients receive mirabegron daily for 12 weeks
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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 in the 4 weeks prior to enrollment

Primary outcomes:
measure: Response to Therapy
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)
timeFrame: 12 weeks
measure: Change in Urinary Distress Inventory (UDI)
timeFrame: 12 weeks
measure: Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score
timeFrame: 12 weeks
measure: Change in Colo-Rectal-Anal Distress Inventory (CRADI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola Univerity Medical Center
name: Alan Wolfe, PhD
role: PRINCIPAL_INVESTIGATOR
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