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RECRUITING
NCT05806164
PHASE4

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Sponsor: Women and Infants Hospital of Rhode Island

View on ClinicalTrials.gov

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

Interventions

DRUG

Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]

The beta-agonist oral medication will be prescribed and dose adjusted per usual care.

DRUG

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