Clinical Trial

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Study acronym: BEST
Active, Not Recruiting Phase 4
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Summary
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity. The study will also have a long-term follow-up component (prospective cohort) including 346 participants from the parent trial to describe treatment continuation, treatment efficacy, patient direct costs and other secondary outcomes up to 5 years after treatment.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-03-28; most recent amendment 2026-06-24.
Status change: Recruiting → Active, Not Recruiting 2026-06-24
Status change: Not Yet Recruiting → Recruiting 2023-06-05
Trial Details
NCT Number NCT05806164
Lead Sponsor Women and Infants Hospital of Rhode Island
Collaborators: University of New Mexico, University of Alabama at Birmingham, University of California, San Diego, Howard University, Brown University, Patient-Centered Outcomes Research Institute
Conditions Urgency Urinary Incontinence
Enrollment 432 participants
Start Date 2023-06-06
Primary Completion 2026-08-30 (estimated)
Study Completion 2030-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-29