A year after their procedures at the Mayo Clinic, 97 percent of the women who had Focused Ultrasound treatments for uterine fibroids said their symptoms had improved. Ninety percent considered their improvement either “considerable” or “excellent.”
So reported Gina Hesley, M.D., an interventional radiologist at Mayo, who is studying the long-term effectiveness of Focused Ultrasound treatments for uterine fibroids. She presented her findings at the Society of Interventional Radiology’s 35th Annual Scientific Meeting in Tampa.
The Mayo study is following 119 patients, 89 of whom provided feedback during telephone interviews a year after their procedures. Each will be interviewed again on the second and third anniversaries of their procedures.
While the results are promising, Hesley cautioned, longer-term effectiveness of the focused ultrasound treatment needs continued study. In an interview for this newsletter, Hesley detailed her research and its potential implications.
Q. How is this study contributing to the overall field of uterine fibroid treatments?
Hesley: It’s demonstrating that patients are satisfied with the treatment, have acceptable relief of their symptoms and that the treatment is as durable as therapies such as Uterine Artery Embolization (UAE) or myomectomy.
Q. In what ways could the study advance clinical applications of Focused Ultrasound technology?
Hesley: It could demonstrate to patients, clinicians and insurance providers that this is an acceptable treatment option for women with uterine fibroids.
Q. What are you doing to ensure that a statistically significant number of patients participate in your 24-month and 36-month follow-ups?
Hesley: It is difficult to maintain contact with all patients as they move, change jobs, etc. We have a dedicated patient coordinator who speaks with the patients from their initial phone call throughout their years of follow-up. This aids in patient retention.
Q. 8% of study participants required additional treatments. What treatments did they receive and why?
Hesley: Six received hysterectomies and two had myomectomies due to continued fibroid symptoms. Eight percent is within values reported for UAE and myomectomy.
Q. What framework/specific reference will you use to compare your results with MR-guided FUS with those reported for UAE and myomectomy?
Hesley: We will compare the need for alternative treatments and improvement in patient symptoms.
Q. What other Focused Ultrasound research are you conducting or planning?
Hesley: We are involved in evaluating the clinical utility of the ExAblate 2000 device and long-term treatment outcomes in comparison with other treatment options, especially UAE. We are currently conducting a NIH study comparing Focused Ultrasound and UAE. We are also involved in improving fibroid imaging options that would aid in fibroid characterization, patient selection and treatment assessment.
Looking toward the future, we are interested in treating patients with adenomyosis specifically. Adenomyosis is a condition in which tissue that normally lines the uterus also grows within the muscular walls of the uterus.
Q. How long have you been using Focused Ultrasound to treat uterine fibroids?
Hesley: Since July 2002 when I became involved in the Phase 2 clinical trial for ExAblate 2000 device. I now treat 50-80 patients with Focused Ultrasound annually.
Q. Why did you become interested in Focused Ultrasound?
Hesley: It’s nice for women to have a variety of treatment options to manage their fibroid symptoms. This is an excellent option for many women offering them a non-invasive and safe but effective treatment alternative.