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Methods for a Community-Engaged Randomized Trial for Urgency Incontinence.

Vivian W Sung1, Holly E Richter2, Emily S Lukacz3

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PubMed
Summary
This summary is machine-generated.

The BEST trial compares beta-agonist medication and onabotulinumtoxinA injections for urgency urinary incontinence (UUI). Patient input guided this study, which will provide crucial comparative efficacy data for UUI treatment.

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Area of Science:

  • Urology
  • Pharmacology
  • Clinical Trials

Background:

  • Urgency urinary incontinence (UUI) affects many women, with beta-agonist medication and onabotulinumtoxinA injections being common treatments.
  • Limited comparative efficacy data exists for these UUI treatments, hindering optimal clinical practice.
  • The Beta-Agonist versus ONA Trial for Urgency Urinary Incontinence (BEST) was designed with patient and stakeholder input to address this gap.

Purpose of the Study:

  • To compare the efficacy of beta-agonist medication versus onabotulinumtoxinA injections for treating UUI.
  • Primary endpoints include symptom severity and treatment satisfaction at 3 months.
  • Secondary objectives assess quality of life, global improvement, cognitive/sexual function, complications, and treatment barriers.

Main Methods:

  • A multisite, single-blinded, randomized trial comparing beta-agonist and onabotulinumtoxinA in female participants with UUI.
  • 432 participants are planned to provide 80% power to detect a 15% difference in coprimary outcomes.
  • Intention-to-treat analysis using linear mixed-effects models is planned.

Main Results:

  • Enrollment began July 2023; as of January 2026, 92% of participants are randomized.
  • 82% of randomized participants have reached the 3-month primary outcome with high retention rates.
  • 54% have reached the 12-month outcome with maintained retention.

Conclusions:

  • The BEST trial design was significantly influenced by patient and stakeholder input.
  • This study will yield patient-important comparative efficacy data for beta-agonist versus onabotulinumtoxinA in UUI treatment.