Mirabegron and Urinary Urgency Incontinence
Completed · Phase 4
Conditions studied: Overactive Bladder
In brief
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.
Key facts
- Study ID
- NCT02495389
- Run by
- Loyola University
- People needed
- 84
- Starts
- 2015-01-28
- Expected to finish
- 2019-01-29
- Last updated by the study team
- 2020-11-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Loyola University Medical Center — Maywood, Illinois, United States
Full record on ClinicalTrials.gov
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