Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
- Conditions
- Urgency Urinary Incontinence
- Interventions
- Drug: Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]
- Registration Number
- NCT05806164
- Lead Sponsor
- Women and Infants Hospital of Rhode Island
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 432
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intradetrusor onabotulinumtoxinA OnabotulinumtoxinA 100 UNT [Botox] OnabotulinumtoxinA at a dose of 100 units will be injected into the bladder per usual care pathways. Beta-3 receptor agonist oral medication Beta3-Agonists, Adrenergic [Mirabegron/Vibegron] Selective beta-3 receptor agonist oral medication approved for the treatment of urgency urinary incontinence including mirabegron or vibegron. Usual clinical care standards will be used for prescribing and dosing changes. For mirabegron, dosages are 25 mg and 50 mg as clinically indicated. For vibegron, dosage is 75 mg daily by mouth as clinically indicated.
- Primary Outcome Measures
Name Time Method Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months 3 months Single item "How do you rate this treatment overall" on a 5-point likert scale
Change in score Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) at 3 months Baseline until 3 months 8-item questionnaire measuring symptom bother of overactive bladder symptoms, higher scores indicate more bothersome symptoms
- Secondary Outcome Measures
Name Time Method Change in Overactive Bladder Questionnaire-Symptom Bother Scale (OAB-q-SS) Baseline until 6, 9, 12 months 8-item questionnaire measuring symptom bother of overactive bladder symptoms
Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General Questionnaire (FACIT-TS-G) at 3 months 6, 9, 12 months 8-item questionnaire assessing treatment satisfaction of adults undergoing treatment for chronic conditions
Change in Overactive Bladder Questionnaire-Health Related Quality of Life (OAB-q-HRQL) Baseline to 3, 6, 9, 12 months Overactive bladder disease specific questionnaire measuring quality of life, higher scores indicate better HRQL
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR) Baseline to 3, 6, 9, 12 months Validated tool assessing female sexual function in women with pelvic floor disorders; higher scores reflect better sexual functioning
Patient global impression of improvement (PGI-I) 3, 6, 9, 12 months Global measure of patient impression of improvement, likert scale
Trial Locations
- Locations (5)
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, San Diego
🇺🇸San Diego, California, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States