Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| uterine artery embolization | Procedure | |||
| hysterectomy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the normalization of menorrhagia after a two-year follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on complaints of pain and pressure | ||
| Technical failure | ||
| Complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| J.A. Reekers, MD, PhD | Academic Medical Centre, Department of Radiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Centre Amsterdam | Amsterdam | 1105 AZ | Netherlands | |||
| 27 Other Participating Hospitals of Varying Sizes Throughout the Country |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15547547 | Result | 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. | |
| 17671809 | Derived | 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. |
| Label | URL |
|---|---|
| Information site of the Emmy trial for patients (in Dutch) | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| D007889 | Leiomyoma |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D055357 | Uterine Artery Embolization |
| D007044 | Hysterectomy |
| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quality of life issues |
| Uterine volume reduction |
| Effect on ovarian function |
| Cost-effectiveness |
| Amsterdam |
| Netherlands |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D013509 |
| Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |