Adenomyosis endometrium in uterine wall muscle.
Conditions
Interventions
UAE, performed by experienced interventional radiologists versus hysterectomy
(laparoscopically, abdominally or vaginally).
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Premenopausal women with symptomatic adenomyosis or dominant adenomyosis in combination with fibroids. • Woman who are (due to complaints and non responsive former treatment strategies) eligible for hysterectomy • No wish to conceive • Able to understand Dutch or English language.
Exclusion criteria
Exclusion criteria: • Younger than 18 years of age • Pelvic infection/Suspicion or presence of malignancy • Current pregnancy • Contra-indication for angiography (such as contrast fluid allergy, coagulopathy and renal failure), when not treatable • Deep infiltrating endometriosis requiring surgery or with risks on intestinal stenosis • Concurrent removable submucous fibroids (Patients eligible after removal)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: quality of life as measured by a combination of the World Health Organization Quality-of-Life Scale (WHOQOL-Bref) and short-form-12 (SF-12) questionnaire at 26 weeks after therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The two treatments will also be compared in terms of Clinical outcomes, Recovery related outcomes, Quality of life outcomes and cost outcomes. Also imaging outcomes will be investigated at baseline in order to identify potential predictive parameters for therapy effect. | — |
Countries
Netherlands
Outcome results
None listed