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

Primary Purpose

Menorrhagia, Leiomyoma, Uterine Neoplasms

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
uterine artery embolization
hysterectomy
Sponsored by
ZonMw: The Netherlands Organisation for Health Research and Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring hysterectomy, fibroids, uterine artery embolization, therapeutic embolization, uterus, menorrhagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Academic Medical Centre Amsterdam
  • 27 Other Participating Hospitals of Varying Sizes Throughout the Country

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect on complaints of pain and pressure
Technical failure
Complications
Quality of life issues
Uterine volume reduction
Effect on ovarian function
Cost-effectiveness

Full Information

First Posted
December 23, 2004
Last Updated
June 23, 2005
Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00100191
Brief Title
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

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators
Boston Scientific Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia, Leiomyoma, Uterine Neoplasms
Keywords
hysterectomy, fibroids, uterine artery embolization, therapeutic embolization, uterus, menorrhagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
uterine artery embolization
Intervention Type
Procedure
Intervention Name(s)
hysterectomy
Primary Outcome Measure Information:
Title
The primary endpoint is the normalization of menorrhagia after a two-year follow-up period
Secondary Outcome Measure Information:
Title
Effect on complaints of pain and pressure
Title
Technical failure
Title
Complications
Title
Quality of life issues
Title
Uterine volume reduction
Title
Effect on ovarian function
Title
Cost-effectiveness

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.A. Reekers, MD, PhD
Organizational Affiliation
Academic Medical Centre, Department of Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Centre Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
27 Other Participating Hospitals of Varying Sizes Throughout the Country
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
15547547
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.
Results Reference
result
PubMed Identifier
17671809
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.
Results Reference
derived
Links:
URL
http://www.emmystudie.nl
Description
Information site of the Emmy trial for patients (in Dutch)

Learn more about this trial

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

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