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Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids

EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00100191
Enrollment
120
Registered
2004-12-24
Start date
2002-02-28
Completion date
2006-04-30
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leiomyoma, Menorrhagia, Uterine Neoplasms

Keywords

hysterectomy, fibroids, uterine artery embolization, therapeutic embolization, uterus, menorrhagia

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.

Interventions

PROCEDUREhysterectomy

Sponsors

Boston Scientific Corporation
CollaboratorINDUSTRY
ZonMw: The Netherlands Organisation for Health Research and Development
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period

Secondary

MeasureTime frame
Cost-effectiveness
Effect on complaints of pain and pressure
Technical failure
Effect on ovarian function
Quality of life issues
Uterine volume reduction
Complications

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026