Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Running, not enrolling · Phase 4

Conditions studied: Urgency Urinary Incontinence

In brief

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 facts

Study ID

NCT05806164

Run by

Women and Infants Hospital of Rhode Island

People needed

432

Starts

2023-06-06

Expected to finish

2030-08-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• clinical contraindication to beta-3 agonist or onabotulinumtoxinA
• prior therapeutic trial of either study treatment
• unevaluated hematuria, current or prior bladder malignancy
• surgically altered detrusor muscle
• prior pelvic radiation
• post-void residual >150 mL in past 3 months
• neurogenic bladder
• pelvic floor surgery within the past 3 months
• anticipating pelvic surgery within primary outcome follow up period (3 months)

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.