Clinical Research Directory
Browse clinical research sites, groups, and studies.
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
Sponsor: Women and Infants Hospital of Rhode Island
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
432
Start Date
2023-06-06
Completion Date
2030-08-01
Last Updated
2025-09-25
Healthy Volunteers
Yes
Conditions
Interventions
Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]
The beta-agonist oral medication will be prescribed and dose adjusted per usual care.
OnabotulinumtoxinA 100 UNT [Botox]
OnabotulinumtoxinA will be prepared by dissolving 100 units into 10 ml of injectable saline. The injection will be an office based procedure, performed per usual care.
Locations (5)
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