Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Description

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.

Conditions

Urgency Urinary Incontinence

Study Overview

Study Details

Study overview

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.

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Condition
Urgency Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

San Diego

University of California, San Diego, San Diego, California, United States, 92093

Washington

Howard University, Washington, District of Columbia, United States, 20059

Albuquerque

University of New Mexico, Albuquerque, New Mexico, United States, 87131

Providence

Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States, 02905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Women and Infants Hospital of Rhode Island,

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

Peter Jeppson, MD, PRINCIPAL_INVESTIGATOR, University of New Mexico

Study Record Dates

2027-07-15