RECRUITING

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Quick Facts

Study Start:2023-06-06
Study Completion:2030-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05806164

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. clinical contraindication to beta-3 agonist or onabotulinumtoxinA
  2. 2. prior therapeutic trial of either study treatment
  3. 3. unevaluated hematuria, current or prior bladder malignancy
  4. 4. surgically altered detrusor muscle
  5. 5. prior pelvic radiation
  6. 6. post-void residual \>150 mL in past 3 months
  7. 7. neurogenic bladder
  8. 8. pelvic floor surgery within the past 3 months
  9. 9. anticipating pelvic surgery within primary outcome follow up period (3 months)

Contacts and Locations

Study Contact

Ann Meers, BS, RN
CONTACT
401-274-1100
ameers@wihri.org
Sara Veera, BS
CONTACT
401-274-1100
sveera@wihri.org

Principal Investigator

Vivian Sung, MD, MPH
PRINCIPAL_INVESTIGATOR
Women and Infants Hospital of Rhode Island
Peter Jeppson, MD
PRINCIPAL_INVESTIGATOR
University of New Mexico

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
University of California, San Diego
San Diego, California, 92093
United States
Howard University
Washington D.C., District of Columbia, 20059
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-06
Study Completion Date2030-08-01

Study Record Updates

Study Start Date2023-06-06
Study Completion Date2030-08-01

Terms related to this study

Keywords Provided by Researchers

  • UUI
  • Urgency Incontinence
  • Beta Agonist
  • onabotulintoxinA
  • Botox
  • Community Engagement

Additional Relevant MeSH Terms

  • Urgency Urinary Incontinence