Phase 4
Completed N=84
Mirabegron and Urinary Urgency Incontinence
Source: ClinicalTrials.gov NCT02495389 ↗Enrolled (actual)
84
Serious AEs
2.4%
Results posted
Nov 2020
Primary outcomePrimary: Response to Therapy — 15; 29 Participants
◆ Published Evidence
Emerging
10citations · ~3 / year
Symptom improvement with mirabegron treatment is associated with urobiome changes in adult women.
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.
Linked Publications
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Symptom improvement with mirabegron treatment is associated with urobiome changes in adult women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response to Therapy |
15; 29 | — |
| SECONDARY Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) |
50.92; 74.88; 23.96 | <.0001 sig |
| SECONDARY Change in Urinary Distress Inventory (UDI) |
121.25; 69.62; -51.62 | <.0001 sig |
| SECONDARY Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score |
77.85; 48.55; -29.30 | <.0001 sig |
| SECONDARY Change in Colo-Rectal-Anal Distress Inventory (CRADI) |
94.50; 62.50; -32.00 | <.0001 sig |
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
Data sourced from ClinicalTrials.gov (NCT02495389) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.