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drugset / Trial / NCT05806164

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

NCT05806164 ↗

Phase 4 Active not recruiting 432 enrolled Women and Infants Hospital of Rhode Island Brown University · collabHoward University · collabPatient-Centered Outcomes Research Institute · collabUniversity of Alabama at Birmingham · collabUniversity of California, San Diego · collabUniversity of New Mexico · collab
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2023-06-06
Primary completion
2026-08-30
Completion
2030-08-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 100 iu Other
Comparator Mirabegron Other / unclassified 25 mg Oral
Comparator Mirabegron Other / unclassified 50 mg Oral
Comparator Vibegron Unknown 75 mg Oral

Indications

overactive bladder