EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids
Uterine Artery Embolization (UAE) is a new treatment for heavy menstrual bleeding caused by
uterine fibroids. UAE is already being performed on a regular basis, without profound
evidence: no good quality randomized controlled trials have been conducted. The EMMY trial
evaluates the safety and efficacy of UAE in a randomized comparison to hysterectomy.
Patients were included when they had uterine fibroids and menorrhagia, and were eligible for
hysterectomy. The primary endpoint is the elimination of menorrhagia after a two-year
follow-up period. Secondary endpoints comprise: effect on complaints of pain and pressure,
quality of life issues, uterine volume reduction, effect on ovarian function and
cost-effectiveness. Patients were randomly assigned to either UAE or hysterectomy (1:1).
All patients were followed for two years after treatment. Whether UAE can be an alternative
to hysterectomy as treatment of first choice depends on the balance of efficacy, costs, and
quality of life.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
J.A. Reekers, MD, PhD
Academic Medical Centre, Department of Radiology
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)