Maywood, Illinois 60153


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02495389


Primary Contact:

Principal Investigator
Alan Wolfe, PhD
Loyola Univerity Medical Center

Alan Wolfe, PhD
Phone: 708-216-5814
Email: awolfe@luc.edu


Backup Contact:

N/A


Location Contact:

Maywood, Illinois 60153
United States

Alan Wolfe, PhD
Phone: 708-216-5814
Email: awolfe@luc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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