Beta-Agonist versus Botox A® Trial for Urgency Urinary Incontinence (BEST) Trial: Therapy for Urge Urinary Incontinence

Click the play button to start the video and learn more about urgency urinary incontinence.

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 the University of Alabama at Birmingham and Alabama communities.

Participating sites: 

• University of Alabama at Birmingham, Birmingham, AL
  • Contact: Sunita Patel, sunitapatel@uabmc.edu, (205) 996-0241 or Donna Cox, dcox@uabmc.edu, (205) 934-1776
• Howard University, Washington, DC
  • Contact: Gabriela Armendariz-Aguirre, Gabriela.Armendariz@howard.edu , (202) 865-4175
• 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

Anticholinergic medications include:

• Oxybutynin (Ditropan XL, Oxytrol, Gelnique)
• Tolterodine (Detrol, Detrol LA)
• Darifenacin.
• Solifenacin (Vesicare, Vesicare LS)
• Trospium.
• Fesoterodine (Toviaz)

Contact:

If you would like more information about the study, please call or email Donna Cox at 205-934-5498 | dcox@uabmc.edu

Complete this form to let us know you are interested: Urogynecology Clinical Trial Screening Form