A national multi-center study aims to determine which uterine fibroid treatments are most effective. But instead of seeking answers from doctors, researchers are collecting data from an unexpected yet powerful source—real women living with the condition.
“Women wanted answers to questions that addressed treatment effectiveness in terms of symptom relief and effects on future fertility,” says Dr. Evan R. Myers, MD, MPH, Professor of Obstetrics and Gynecology at Duke University School of Medicine and the Duke Clinical Research Institute, and the study’s Principal Investigator. “One of the things that’s become clear over the past few years as patients have been participating in developing research programs is that, particularly for this condition where hysterectomy is one of the potential treatments, women wanted more control over the treatment they chose. They were more interested in being part of a registry—or observational study—rather than a randomized trial.
The 5-year study entitled, Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF) seeks to understand which fibroid treatment options work best by observing factors that influence treatment outcomes.
Funded in 2014 with a $20 million grant from the Patient-Centered Outcomes Research Institute (PCORI) administered by the Agency for Healthcare Research and Quality (AHRQ), researchers hope to recruit thousands of women from nine different clinical centers across the nation. After collecting pre-treatment information about medical history and symptoms, participating women will answer specific questions about which treatments they chose and how well these treatments are working at annual intervals.
This direct line of questioning is essential because uterine fibroids are unique to each woman—making a one-size-fits-all approach to treatment impossible. Fibroids affect as many as 3 out of 4 women, with African American women being most at risk.1 And although these tumors are noncancerous, they grow in different sizes, numbers, and locations within the uterine wall and can be the cause of an array of symptoms like pelvic pain and pressure, heavy bleeding, incontinence, and infertility. To treat such symptoms, an estimated 30%-50% of women with fibroids seek treatment.2
Instead of seeing these differences among women as obstacles, the COMPARE-UF team considers them an asset to their research and the key to targeting the most advantageous treatment options.
Dr. Myers explains that by proactively gathering and examining images of what a woman’s uterus looked like before a procedure, it’s possible to illustrate how varying factors—like fibroid size and location—could influence the outcome of a procedure. “To be able to compare treatment outcomes, we really need to know how women are different in terms of symptoms and uterine anatomy before they underwent a procedure. That’s something you just can’t tell from administrative records or most common databases.”
What’s more, COMPARE-UF is looking for factors, including hormones, that may predict the impact of specific treatments for individual women. For example, anti-mullerian hormone (AMH) levels can be a good predictor of when a woman will undergo menopause. “Knowing ahead of time might be very useful,” Dr. Myers tells Ask4UFE. “Some procedures can cause ovarian aging and make menopause happen sooner. Having this information in advance could be useful in terms of helping women decide which procedure is right given where they are in life.”
Currently, COMPARE-UF sites include University of Mississippi Medical Center, Department of Defense Clinical Consortium, Mayo Clinic Collaborative Network, University of California Fibroid Network, Henry Ford Health System, University of North Carolina, Brigham and Women/Harvard Clinical Center, Inova Health Systems, and University of Michigan.
Utilizing a wide range of medical centers offers patient diversity, differences in procedure availability, and access to various levels of healthcare coverage. This variety will help tackle questions about health disparities existing among women with fibroids that have gone unanswered.
“Not having access to quality healthcare is a problem,” Dr. Myers continues. “One of the questions that’s tough to answer, in terms of the disparities for fibroids, is how much of it is due to biological differences and how much of it may be due to differences in access to care. By including sites, like Department of Defense medical centers, where access to healthcare isn’t a problem, we’re able to begin to address these questions.”
In the future, the COMPARE-UF team hopes to expand the study by adding more sites and even making enrollment open to women anywhere in the nation simply by registering online. Also, by potentially extending the length of the study, more long-term data regarding pregnancy outcomes and fibroid recurrence can be collected.
“Fibroids are a burden with immense quality of life implications. And still we don’t know much about how to treat it,” Dr. Myers reports. ”We’re hoping to be able to give better information to women about the likelihood of what to expect with different procedures, given their unique situation and options available to them. Our ultimate goal is to collect information that’s going to help women decide what’s best for them.”
ABOUT THE AUTHOR Alicia Armeli is a Health Freelance Writer, Registered Dietitian Nutritionist, and Certified Holistic Life Coach. She has master’s degrees in English Education and Nutrition. Through her writing, she empowers readers to live optimally by building awareness surrounding issues that impact health and wellbeing. In addition to writing, she enjoys singing, traveling abroad and volunteering in her community.
ABOUT THE DOCTOR Evan R. Myers, MD, MPH, is the Walter L. Thomas Professor of Obstetrics and Gynecology at Duke University School of Medicine and Principal Investigator of COMPARE-UF. His research encompasses a number of women’s health issues, including cancer prevention and treatment, pregnancy complications, and uterine fibroids. Through his work, Dr. Myers strives to ensure women are able to make informed treatment decisions.
- COMPARE-UF. (2016). Welcome to COMPARE. Retrieved October 3, 2016, from http://compare-uf.org/welcome-to-compare/
- Soliman, A. M., Yang, H., Du, E. X., Kelkar, S. S., & Winkel, C. (2015). The direct and indirect costs of uterine fibroid tumors: a systematic review of the literature between 2000 and 2013. American Journal of Obstetrics and Gynecology, 213(2): 141-160. doi: 10.1016/j.ajog.2015.03.019