New Study Aims to Compare Uterine Fibroids Treatments

The MYCHOICE study has begun enrolling participants to compare cost-effectiveness of uterine fibroid treatments, according to the researchers.

Magnetic resonance image–guided, high‑intensity, focused ultrasound (MR-HIFU) is a relatively new, noninvasive treatment for uterine fibroids that offers quick recovery as well as safety and effectiveness. However, little prospectively collected data supports reimbursement for its provision.

To assess the long-term cost-effectiveness of MR-HIFU treatment compared with that of standard, minimally invasive fibroid treatment, a Dutch research team has initiated a multicenter, open, randomized, controlled trial called MYCHOICE. The team plans to enroll 240 premenopausal women in the trial who are at least 18 years old, who have been diagnosed with symptomatic uterine fibroids, in whom conservative treatment has failed or is not accepted, and who are eligible for MR‑HIFU. 

The trial began enrolling participants in November 2020 and will continue until 2024. Once the designated number of participants has been enrolled, the researchers plan to randomly assign participants to MR-HIFU or standard-of-care treatment in a 2:1 ratio.

The primary outcomes of the study are quality of life at 24 months post-treatment and cost of treatment, which encompasses patient costs and lost productivity as well as direct costs of health care. The researchers expect to complete data collection for the study in 2026.

“By collecting data on the long-term (cost-)effectiveness of the MR-HIFU treatment in comparison to [that of] current standard fibroid care, we provide currently unavailable evidence about the proper place of MR-HIFU in the fibroid treatment spectrum. This will also facilitate reimbursement and inclusion of MR-HIFU in (inter)national uterine fibroid care guidelines,” the researchers explained.

—Ellen Kurek

Reference:

Anneveldt KJ, Nijholt IM, Schutte JM, et al. Comparison of (cost-)effectiveness of magnetic resonance image-guided high-intensity-focused ultrasound with standard (minimally) invasive fibroid treatments: protocol for a multicenter randomized controlled trial (MYCHOICE). JMIR Res Protoc. Published online November 24, 2021. https://doi.org/10.2196/29467