Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence

Phase

Condition

Urinary Incontinence

Enuresis

Treatment

OnabotulinumtoxinA 100 UNT [Botox]

Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]

Clinical Study ID

NCT05806164

1895985

Ages > 18
Female
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion criteria*:

18 years or older
report at least "quite a bit bothered" or worse by their UUI defined by response toOAB-q-SS item #8 "How bothered are you by urine loss associated with a strong desireto urinate?"
are not and do not plan to become pregnant
have persistent UUI defined as previous unsuccessful results after conservative andanticholinergic treatment, or are unable to tolerate or have contraindications toanticholinergics
are currently not taking anticholinergics or are willing to stop medication for 3weeks prior to enrollment.
for participants reporting mixed urinary incontinence symptoms, participant must (a)have less bother from SUI than from UUI, defined as a response of "Not at allbothered" or only "a little bit bothered" by SUI on the Urogenital DistressInventory item "Do you experience urine leakage related to physical activity? (walking, running, laughing, sneezing, coughing), and (b) SUI symptoms be stable (> 3 months), and (c)participant does not desire additional treatment for SUI in theupcoming 3 months.
Participants after unsuccessful neuromodulation trial can be eligible after a 4-weekwashout period.

Exclusion

Exclusion criteria:

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

Study Design

OnabotulinumtoxinA 100 UNT [Botox]

June 06, 2023

July 15, 2027

Study 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.

Connect with a study center

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

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