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


Phase 3
18 Years
N/A
Not Enrolling
Female
Menorrhagia, Leiomyoma, Uterine Neoplasms

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

J.A. Reekers, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Academic Medical Centre, Department of Radiology

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

NWO-DO 945-01-17

NCT ID:

NCT00100191

Start Date:

February 2002

Completion Date:

April 2006

Related Keywords:

  • Menorrhagia
  • Leiomyoma
  • Uterine Neoplasms
  • hysterectomy
  • fibroids
  • uterine artery embolization
  • therapeutic embolization
  • uterus
  • menorrhagia
  • Neoplasms
  • Leiomyoma
  • Myofibroma
  • Menorrhagia
  • Uterine Neoplasms

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