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

Phase 3

Completed

• Conditions: Menorrhagia; Leiomyoma; Uterine Neoplasms

• Registration Number: NCT00100191
• Lead Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development

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 Timeline

• Study Start: 2002-02
• Status Verified: 2004-12
• Study First Submitted: 2004-12-23
• Study First Submitted QC: 2004-12-23
• Study First Posted: 2004-12-24
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24
• Study Completion: 2006-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Academic Medical Centre Amsterdam; 🇳🇱 Amsterdam, Netherlands

27 Other Participating Hospitals of Varying Sizes Throughout the Country; 🇳🇱 Amsterdam, Netherlands