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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2006-04-30

Brief Summary

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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

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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.

Conditions

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Menorrhagia Leiomyoma Uterine Neoplasms

Keywords

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hysterectomy fibroids uterine artery embolization therapeutic embolization uterus menorrhagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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uterine artery embolization

Intervention Type PROCEDURE

hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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J.A. Reekers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academic Medical Centre, Department of Radiology

Locations

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Academic Medical Centre Amsterdam

Amsterdam, , Netherlands

Site Status

27 Other Participating Hospitals of Varying Sizes Throughout the Country

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT

PMID: 15547547 (View on PubMed)

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.

Reference Type DERIVED

PMID: 17671809 (View on PubMed)

Other Identifiers

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NWO-DO 945-01-17

Identifier Type: -

Identifier Source: org_study_id