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Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

NCT05806164 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

  • Urgency Urinary Incontinence

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.

Sponsors & Collaborators

  • University of New Mexico

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • Howard University

    collaborator OTHER

  • Brown University

    collaborator OTHER

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Vivian Sung, MD, MPH · Women and Infants Hospital of Rhode Island

  • Peter Jeppson, MD · University of New Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-06
Primary Completion
2026-07-15
Completion
2030-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05806164 on ClinicalTrials.gov