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

NCT00100191CompletedPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Enrollment

120

Start Date

2002-02-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

uterine artery embolizationhysterectomy

Conditions

MenorrhagiaLeiomyomaUterine Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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)

Outcome Measures

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

Locations

Academic Medical Centre Amsterdam, Amsterdam, Netherlands

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