Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence — BEST  

Urgency Urinary Incontinence Clinical Trial

Official title: Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The purpose of this study is to directly compare 2 primary outcomes (Treatment satisfaction and urinary symptom severity) between beta agonist oral medication versus onabotulinumtoxinA intradetrusor bladder injection for the treatment of UUI. The study will also compare secondary outcomes identified as important by patients. At the end of the study, the investigators will have patient and stakeholder-derived comparative outcomes between these 2 commonly available treatment categories. A stakeholder and community engagement (CE) plan will be developed and implemented. The investigators will also develop a model to help guide patients and providers through this decision process. SPECIFIC AIMS Specific Aim 1: Compare the efficacy of beta agonist versus onabotulinumtoxinA on patient-important treatment outcomes at 3 months in women with UUI. This multi-center, randomized clinical trial (RCT) includes 5 sites across the U.S. Two co-primary outcomes will be measured using validated patient-reported outcomes (PROs), selected by patients: Co-primary outcome 1: Symptom severity, measured by change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) score. Co-primary outcome 2: Treatment satisfaction, measured by the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General (FACIT-TS-G), powered based on a single item. Specific Aim 2: Compare secondary patient-important outcomes. Direct comparisons between intervention effects on secondary outcomes chosen by patients and stakeholders, including adverse events, UUI quality of life, global improvement, and sexual function. Specific Aim 3: Use predictive modeling to help stakeholders better determine expected outcomes after treatment with beta agonist versus onabotulinumtoxinA. Comparators: Beta agonist oral medication (mirabegron or vibegron) versus intradetrusor onabotulinumtoxinA. Both beta-agonists and onabotulinumtoxinA are US Food and Drug Administration (FDA) approved for the treatment of UUI, and widely available options with established efficacy. 432 women will be randomly assigned to each treatment option: 216 to beta agonist oral medication and 216 to intradetrusor onabotulintoxinA. Women will be undergo outcomes assessments at 3, 6, 9, and 12 months. The primary outcome measure will be at 3 months. ;

Related Conditions & MeSH terms

• Enuresis
• Urgency Urinary Incontinence
• Urinary Incontinence

• NCT number: NCT05806164
• Study type: Interventional
• Source: Women and Infants Hospital of Rhode Island
• Contact: Ann Meers, BS, RN
• Phone: 401-274-1100
• Email: ameers@wihri.org
• Status: Recruiting
• Phase: Phase 4
• Start date: June 6, 2023
• Completion date: July 15, 2027