Research Center: Howard University College of Medicine
Location: Howard University Hospital, 2041 Georgia Avenue NW. Washington, DC 20060, United States
Lead Researcher: Dr. Tatiana Sanses
IRB: This study has been reviewed and approved by the Howard University Institutional Review Board

Urgency Urinary Incontinence is a sudden, strong urge to urinate that is hard to stop (the “got to go, got to go right now” feeling). Women with this type of incontinence suffer from urinary leakage that they can’t control when they get a strong sensation to empty the bladder. UUI is a very common condition, affecting 20% of women over the age of 45 and up to 50% of women over the age of 60. UUI can have a negative effect on women’s quality of life. 

The goal of this study is to compare two treatments: Mirabegron or Vibegron (oral medications) versus Botox A® (an injected medication). Both have demonstrated effectiveness in managing UUI, yet a direct head-to-head comparison has yet to determine which treatment suits which patient best.

Interested in learning more about managing UUI and finding the right treatment for you? Read on to learn more!

• Participants will receive a new potential treatment for Urgency Urinary Incontinence (UUI). All clinic visits for both Beta-3 Agonist medication and BOTOX® go through normal clinical care and health insurance.
• Participants will be compensated for their participation in this study.
• Participants will be contributing valuable information that may benefit women with Urgency Urinary Incontinence (UUI) in the future.
• Participants will be helping to advance medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Women aged 18 and above who are diagnosed with Urgency Urinary Incontinence (UUI)
• Must not be pregnant or planning to get pregnant
• Must have tried anticholinergic medication (e.g., tolterodine (Detrol), oxybutynin (Ditropan), and solifenacin (Vesicare)) in the past without improvement.

The study team will explain the research in its entirety but some details are:

• If you are eligible and say yes to participating, you will be randomly assigned to one of the treatment groups: one will receive Mirabegron or Vibegron (oral medication), and the other will receive Botox A (injected medication). You will be part of this study for up to 1 year from the day you get your treatment. You will be asked to complete questionnaires on your first visit. You will also be asked to complete questionnaires at the 3, 6, 9, and 12-month follow-up visits. Study visits may be done either in person, virtually, or over the phone.

Howard University College of Medicine
Howard University College of Medicine provides students of high academic potential with a medical education of exceptional quality and prepares physicians and other healthcare professionals to serve the underserved. Its particular focus is on the education of disadvantaged students for careers in medicine and its emphasis is placed on developing skills and habits of life-long learning and producing world leaders in medicine. Special attention is directed to teaching and research activities that address healthcare disparities.