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Clinical trialNCT05806164Active, not recruitingPhase 4Interventional

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

SponsorWomen and Infants Hospital of Rhode IslandEnrollment432Urgency Urinary Incontinence
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • University of California, San Diego

    San Diego, California, United States

  • Howard University

    Washington D.C., District of Columbia, United States

  • University of New Mexico

    Albuquerque, New Mexico, United States

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]OnabotulinumtoxinA 100 UNT [Botox]
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
6 Jun 2023
Primary completion
30 Aug 2026
Completion
1 Aug 2030
Last update posted
29 Jun 2026
Registered enrollment
432
Registry id
NCT05806164
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.