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

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.

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

Conditions
-----------------
Menorrhagia, Leiomyoma, Uterine Neoplasms

Intervention / Treatment
-----------------
* Procedure: uterine artery embolization
* Procedure: hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: uterine artery embolization|nan|
|Procedure: hysterectomy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the normalization of menorrhagia after a two-year follow-up period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on complaints of pain and pressure |  |  | 
| Technical failure |  |  | 
| Complications |  |  | 
| Quality of life issues |  |  | 
| Uterine volume reduction |  |  | 
| Effect on ovarian function |  |  | 
| Cost-effectiveness |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysterectomy, fibroids, uterine artery embolization, therapeutic embolization, uterus, menorrhagia