EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
Study Overview
Brief Summary
The Emmy trial is set up to evaluate the safety and efficacy of uterine artery embolization (UAE) in comparison to hysterectomy for the treatment of symptomatic uterine fibroids. UAE was considered equivalent to hysterectomy when at least 75% of patients had normalization of heavy menstrual blood loss after treatment.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Uterine fibroids
- •Menorrhagia
- •Scheduled for hysterectomy
- •Pre-menopausal
Exclusion Criteria
- •Childwish (planning to conceive)
- •Pregnancy
- •Suspected malignancy
- •Untreated pelvic inflammatory disease (PID)
- •Clotting disorders
- •Contrast fluid allergy
- •Presence of intrauterine device (IUD)
- •Renal failure (creatinine > 150 mmol/l)
Outcomes
Primary Outcomes
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
Secondary Outcomes
- Effect on complaints of pain and pressure
- Technical failure
- Complications
- Quality of life issues
- Uterine volume reduction
- Effect on ovarian function
- Cost-effectiveness