Actively Recruiting
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
Led by Women and Infants Hospital of Rhode Island · Updated on 2025-09-25
432
Participants Needed
5
Research Sites
373 weeks
Total Duration
On this page
Sponsors
W
Women and Infants Hospital of Rhode Island
Lead Sponsor
U
University of New Mexico
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Report being quite bothered or worse by urine loss with strong urge to urinate
- Not pregnant and no plans to become pregnant
- Have persistent urgency urinary incontinence after unsuccessful or intolerant to anticholinergic treatment
- Currently not taking anticholinergic medications or willing to stop them 3 weeks before enrollment
- If mixed urinary symptoms, less bothered by stress urinary incontinence than urgency urinary incontinence, stable stress symptoms for over 3 months, and no desire for stress urinary incontinence treatment in next 3 months
- Eligible 4 weeks after unsuccessful neuromodulation trial washout period
You will not qualify if you...
- Contraindication to beta-3 agonist or onabotulinumtoxinA
- Prior trial of either study treatment
- Undiagnosed blood in urine or current/prior bladder cancer
- Surgically altered bladder muscle
- Prior pelvic radiation
- Post-void residual urine volume over 150 mL in past 3 months
- Neurogenic bladder
- Pelvic floor surgery within past 3 months
- Planning pelvic surgery during the 3-month primary outcome period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
3
Howard University
Washington D.C., District of Columbia, United States, 20059
Actively Recruiting
4
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
5
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Actively Recruiting
Research Team
A
Ann Meers, BS, RN
CONTACT
S
Sara Veera, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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