Dr. Vivian Sung, a urogynecologist at Women & Infants Hospital, has been awarded $6.9 million to lead a study on nonsurgical treatment options for urgency urinary incontinence. Sung and her team plan to work closely with more than 400 patients to compare the effectiveness of the oral drug mirabergron and Botox injections, both common treatments for UUI.
The study, funded by the Patient-Centered Outcomes Research Institute, a national nonprofit, is Sung’s second research trial relating to urinary incontinence. About three years ago she led a study comparing surgery and surgery combined with exercises or behavioral therapy as treatments for mixed urinary incontinence.
PBN: How long will this study last, and what are the participating facilities?
SUNG: This trial will last a total of five years, and recruitment will take place over 34 months. There are five participating sites across the country, including Women & Infants (lead site), University of New Mexico, University of Alabama, University of California-San Diego and Howard University.
PBN: Have you prescribed mirabergon and Botox treatments for patients in the past, and, if so, do you have a hypothesis as to which one will prove most effective?
SUNG: Both mirabegron and onabotulinumtoxinA (Botox) are established and commonly recommended treatments that have been shown to improve urgency urinary incontinence.
What is missing is a study that directly compares the two treatments for efficacy and outcome measures that are most important to patients. Each option may have different efficacy and each option will have its own side effects when compared head to head.
Each patient’s individual goals and preferences may be different and currently, we are not able to incorporate those into our counseling and treatment recommendations. This trial will provide information to help patients choose the next best treatment option for them.
PBN: Once the study is complete, how do you plan to use the results?
SUNG: One of the aims of our study is to use predictive modeling to help patients and stakeholders better determine expected outcomes after treatment with mirabegron versus Botox. We will use computer modeling to develop nomograms based on patients’ characteristics and preferences, which can be used to help determine the best course of treatment for an individual.
PBN: How are you incorporating patients into the study beyond participation in the treatment comparison?
SUNG: This is one of the first trials for urgency urinary incontinence in which patients have been a part of the design of the study from the beginning! When our study was under development, we formed a diverse Patient Expert Panel, which included eight patients from across the five participating sites who helped us design the study from the start, including choosing the outcomes we are measuring, determining the best study type and follow-up period, and giving us their important perspectives from a patient point of view. We made several modifications to our study based on their input.
Our Patient Expert Panel will continue to work closely with us to provide valuable guidance, insight and feedback throughout the five years of the study all the way through the implementation and dissemination phases too.
PBN: Is there a community involvement aspect as well?
SUNG: Yes! This study includes a substantial community engagement focus, which is an important opportunity to connect with the communities at the five sites to help reach patients who are commonly underrepresented and those who may have barriers to care-seeking for incontinence.
We have a specialized Community Engagement Team at each site, which includes local and national experts, advocates and representatives of local communities. Community Engagement Studios will be conducted at all of the sites before we start the study to get input from the local communities, which we will then have time to incorporate into our study and maximize engagement.
Elizabeth Graham is a PBN contributing writer.
