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

Menorrhagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00100191
• Other study ID #: NWO-DO 945-01-17
• Status: Completed
• Phase: Phase 3
• First received: December 23, 2004
• Last updated: June 23, 2005
• Start date: February 2002
• Est. completion date: April 2006

Study information

• Verified date: December 2004
• Source: ZonMw: The Netherlands Organisation for Health Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Leiomyoma
• Menorrhagia
• Uterine Neoplasms

Intervention

Procedure:
• uterine artery embolization

• hysterectomy

Locations

Country	Name	City	State
Netherlands	27 Other Participating Hospitals of Varying Sizes Throughout the Country	Amsterdam
Netherlands	Academic Medical Centre Amsterdam	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development	Boston Scientific Corporation

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
Secondary	Effect on complaints of pain and pressure
Secondary	Technical failure
Secondary	Complications
Secondary	Quality of life issues
Secondary	Uterine volume reduction
Secondary	Effect on ovarian function
Secondary	Cost-effectiveness