Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence (BEST)
Urgency Urinary Incontinence
About this trial
This is an interventional treatment trial for Urgency Urinary Incontinence focused on measuring UUI, Urgency Incontinence, Beta Agonist, onabotulintoxinA, Botox, Community Engagement
Eligibility Criteria
Inclusion criteria*: 18 years or older report at least "quite a bit bothered" or worse by their UUI defined by response to OAB-q-SS item #8 "How bothered are you by urine loss associated with a strong desire to urinate?" are not and do not plan to become pregnant have persistent UUI defined as previous unsuccessful results after conservative and anticholinergic treatment, or are unable to tolerate or have contraindications to anticholinergics are currently not taking anticholinergics or are willing to stop medication for 3 weeks prior to enrollment. for participants reporting mixed urinary incontinence symptoms, participant must (a) have less bother from SUI than from UUI, defined as a response of "Not at all bothered" or only "a little bit bothered" by SUI on the Urogenital Distress Inventory item "Do you experience urine leakage related to physical activity? (walking, running, laughing, sneezing, coughing), and (b) SUI symptoms be stable (> 3 months), and (c)participant does not desire additional treatment for SUI in the upcoming 3 months. Participants after unsuccessful neuromodulation trial can be eligible after a 4-week washout period. Exclusion criteria: clinical contraindication to beta-3 agonist or onabotulinumtoxinA prior therapeutic trial of either study treatment unevaluated hematuria, current or prior bladder malignancy surgically altered detrusor muscle prior pelvic radiation post-void residual >150 mL in past 3 months neurogenic bladder pelvic floor surgery within the past 3 months anticipating pelvic surgery within primary outcome follow up period (3 months)
Sites / Locations
- University of Alabama at BirminghamRecruiting
- University of California, San DiegoRecruiting
- Howard UniversityRecruiting
- University of New MexicoRecruiting
- Women & Infants Hospital of Rhode IslandRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Beta-3 receptor agonist oral medication
Intradetrusor onabotulinumtoxinA
Selective beta-3 receptor agonist oral medication approved for the treatment of urgency urinary incontinence including mirabegron or vibegron. Usual clinical care standards will be used for prescribing and dosing changes. For mirabegron, dosages are 25 mg and 50 mg as clinically indicated. For vibegron, dosage is 75 mg daily by mouth as clinically indicated.
OnabotulinumtoxinA at a dose of 100 units will be injected into the bladder per usual care pathways.