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NCT Number: NCT00100191

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

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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hemorrhage Leiomyoma Menstruation Disturbances Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Hemorrhage Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Uterine Artery Embolization

Procedure

Hysterectomy

Procedure

Primary outcomes

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

Secondary outcomes

  1. Effect on complaints of pain and pressure

  2. Technical failure

  3. Complications

  4. Quality of life issues

  5. Uterine volume reduction

  6. Effect on ovarian function

  7. Cost-effectiveness

Sponsors and collaborators

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2006
First posted
Dec 24, 2004
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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