Clinical trial NCT00100191: Emmy Trial: Uterine Artery Embolization (UAE) Versus Hysterectomy for Uterine Fibroids
Official title: EMMY Trial: a Randomized Comparison of Uterine Artery Embolization and Hysterectomy for the Treatment of Symptomatic Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menorrhagia
Leiomyoma
Uterine Neoplasms
Keywords: hysterectomy
fibroids
uterine artery embolization
therapeutic embolization
uterus
menorrhagia
Lead sponsor: ZonMw: The Netherlands Organisation for Health Research and Development
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2004-12-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
Secondary outcomes:
measure: Effect on complaints of pain and pressure
measure: Technical failure
measure: Complications
measure: Quality of life issues
measure: Uterine volume reduction
measure: Effect on ovarian function
measure: Cost-effectiveness
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre Amsterdam
city: Amsterdam
country: Netherlands
facility: 27 Other Participating Hospitals of Varying Sizes Throughout the Country
Study officials:
affiliation: Academic Medical Centre, Department of Radiology
name: J.A. Reekers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hehenkamp WJ, Volkers NA, Van Swijndregt AD, De Blok S, Reekers JA, Ankum WM. Myoma expulsion after uterine artery embolization: complication or cure? Am J Obstet Gynecol. 2004 Nov;191(5):1713-5. doi: 10.1016/j.ajog.2004.02.001.
citation: Hehenkamp WJ, Volkers NA, Bartholomeus W, de Blok S, Birnie E, Reekers JA, Ankum WM. Sexuality and body image after uterine artery embolization and hysterectomy in the treatment of uterine fibroids: a randomized comparison. Cardiovasc Intervent Radiol. 2007 Sep-Oct;30(5):866-75. doi: 10.1007/s00270-007-9121-7.