Beta-Agonist versus Botox A® Trial for Urgency Urinary Incontinence (BEST) Trial: Therapy for Urge Urinary Incontinence
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What is Urgency Urinary Incontinence?
Urgency urinary incontinence (UUI) is a sudden, strong urge to urinate that is hard to stop. Women with this type of incontinence may leak urine on the way to the bathroom, and some may have nighttime problems. It is a common condition in women that can have a negative effect on their quality of life. UUI tends to affect people of older age, and with the aging US population it represents an important public health issue.
What are we studying?
The purpose of this study is to fill the evidence gap with direct-comparison data on patient-important efficacy and safety outcomes between an oral medication (Mirabegron or Vibegron) versus Botox A® in the treatment of UUI.
- Mirabegron and Vibegron are both oral medications that causes bladder muscle relaxation, decreasing UUI.
- Botox A® injections in the bladder lessens UUI by decreasing bladder contractions
- Mirabegron, Vibegron, and Botox A® are US Food and Drug Administration (FDA) approved for the treatment of UUI
How many people will participate in this study?
432 women across 5 sites in the United States will be asked to participate. Approximately 84 women will be patients from Women & Infants Hospital and its communities.
Participating sites:
- Howard University, Washington, DC Contact: Gabriela Armendariz-Aguirre, Gabriela.Armendariz@howard.edu , (202) 865-4175
- University of Alabama, Birmingham, AL Contact: Sunita Patel, sunitapatel@uabmc.edu, (205) 996-0241
- University of California San Diego, San Diego, CA Contact: Kyle Herrala, UrogynRSCH@ucsd.edu, (858) 657-6827
- University of New Mexico, Albuquerque, NM Contact: Madison Gonya, hsc-urogyn-research@salud.unm.edu, (505) 967-8428
- Women & Infants Hospital of Rhode Island, Providence, RI
Will I be compensated?
You will be compensated up to $425 for your participation. $50 at the baseline visit and at the completion of the 6-, 9-, and 12-month follow-up visits and $100 at the 3-month visit, and $125 at treatment initiation. Most visits can be conducted by phone.
All clinic visits for both oral medications and Botox A® go through normal clinical care and your health insurance.
How can I participate?
You may be able to participate based on meeting the following study criteria:
- Women 18 years or older
- Are not and do not plan to become pregnant during the trial
- Have tried anticholinergic medication in the past without improvement
Contact information:
If you are interested in learning more about this study and to find out if you are able to participate, please contact a member of the research team:
Sara Veera, Senior Research Assistant: (401) 430-8222
Ann Meers, Research Supervisor: (401) 430-8228
Denisses Cortorreal, Community Liaison: (401) 430-8226 (habla Español)