Two faculty members in the Department of Obstetrics and Gynecology’s Division of Urogynecology and Pelvic Reconstructive Surgery have been awarded $1,519,450 in funding from Patient-Centered Outcomes Research Institute (PCORI) grants for two different studies focused on urgency urinary incontinence (UUI) in women.
Holly E. Richter, Ph.D., M.D., FACOG, FACS, is a professor in the Department of OB/GYN and holds the Endowed Chair of Obstetrics and Gynecology, and Isuzu Meyer, M.D., MSPH, is an associate professor in the department. Both Richter and Meyer are principal investigators on the studies that are being funded by PCORI – a non-profit research organization that is the leading funder of patient centered comparative clinical effectiveness research (CER) in the U.S.The study led by Meyer, “Reduced-dose OnabotulinumtoxinA for Urgency Incontinence Among Elder Females (RELIEF): A Mixed Methods Randomized Controlled Trial,” is evaluating women 70 years of age and older with refractory UUI or urgency-predominant mixed urinary incontinence (MUI). Potential participants must have failed or have had a contraindication to behavioral therapy and pharmacologic therapy with at least two agents.
The trial will compare the outcomes of different doses of onabotulinumtoxinA (Botox®) as treatment, and it evaluate how the doses affect the patient’s urgency urinary incontinence (UUI) symptoms and quality of life.
“Women in the community have been actively engaged during trial design and will remain active during the course of these studies,” said Meyer.
The other trial, led by Richter, “Beta-Agonist versus Botox® Trial for Urgency Urinary Incontinence (BEST Trial),” is evaluating mirabegron (a newer beta-agonist medication) versus Botox® for persistent UUI. The trial will target women who have tried conservative and anticholinergic treatment for UUI but continue to have bothersome symptoms.
“With the focus on patient-centered outcomes, these trials will provide outcome data that is of primary concern to our patients,” states Richter.
Women are living longer and wish to maintain and improve their activities and quality of life. These two studies will provide important information toward the understanding of effective treatment of UUI over a spectrum of ages.
For more information regarding these trials, please contact Dr. Meyer or Dr. Richter. Interested patients can also visit the Division of Urogynecology and Pelvic Reconstructive Surgery website or call 205-934-5498.