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Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Study acronym: BEST
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 29, 2026 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jul 15, 2026 to Aug 30, 2026
    • Site details revised at 5 of 5 sites
    v7
  2. Study completion date: Jul 15, 2027 to Aug 1, 2030
    • Study description expanded, about 78 words
    • Site contacts updated at 2 of 5 sites
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Eligibility criteria expanded, about 1 wordv4
  5. Start date changed from estimate of Jun 5, 2023 to Jun 6, 2023v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Start date: Jul 1, 2023 to Jun 5, 2023
    • Interventions: Beta3-Agonists, Adrenergic (Drug), OnabotulinumtoxinA 100 UNT [Botox] (Drug) to Beta3-Agonists, Adrenergic [Mirabegron/Vibegron] (Drug), OnabotulinumtoxinA 100 UNT [Botox] (Drug)
    • Eligibility criteria expanded, about 11 words
    • Site details revised at 5 of 5 sites
    • Study description expanded, about 3 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Urgency Urinary Incontinence
Enrollment 432 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov