- The clinical trial compares standard uterine fibroid care with focused ultrasound therapy.
- Participants are randomly selected for standard care or focused ultrasound but have a two-to-one chance of receiving focused ultrasound.
- This trial is the only way for patients in the Netherlands to access focused ultrasound for uterine fibroids.
- In December 2021, the trial protocol was published.
The first patients have been treated in the Netherlands in a clinical trial to compare common treatments for uterine fibroids with focused ultrasound therapy.
The MYCHOICE study will evaluate the (cost)effectiveness of focused ultrasound compared to invasive and minimally invasive uterine fibroid care – hysterectomy, myomectomy, and uterine artery embolization – which are considered the control group. Participants allocated to the control group can decide together with their gynecologist which of the invasive and minimally invasive treatments they wish to undergo. Participants will have a two-to-one chance of being randomized to receive focused ultrasound rather than one of the other treatments. Today, Isala Hospital Zwolle is the first site to participate in the trial, but study organizers aim to enroll a total of 240 patients in at least five sites across the Netherlands.
“A known benefit of focused ultrasound therapy over the treatments offered in the control group is its noninvasive nature,” said Suzanne LeBlang, MD, the Foundation’s Director of Clinical Relationships. “It is our hope that this trial will be successful in its aim to prove focused ultrasound has comparable outcomes of efficacy and cost to the treatments in the control group for these women.”
Focused ultrasound for uterine fibroids has earned regulatory approval in the US, Europe, as well as various other countries around the world. However, reimbursement for the treatment is lacking in many places, and study organizers stress that participating in this trial is currently the only way that women in the Netherlands can access focused ultrasound treatment for uterine fibroids.
“In the MYCHOICE study, we focus on patient-reported outcomes and experiences because we believe that these are most relevant for any treatment option,” said Martijn Boomsma, MD, PhD, radiologist and principal investigator of MYCHOICE. “Besides reimbursement for the focused ultrasound treatment, MYCHOICE also aims to provide valuable information on patients’ preference for a particular treatment.”
Please visit the study’s website for more information, including eligibility criteria, frequently asked questions, and contact information.