QUality of life after Embolization vs. hySTerectomy in Adenomyosis.

Adenomyosis is defined as the benign invasion of endometrial stroma and glands in the myometrium, surrounded by hypertrophic and hyperplastic myometrium. Hysterectomy is established as the final treatment option when conservative treatment fails. Case series for UAE (uterine artery embolization) in adenomyosis patients show promising results. However, a randomized controlled trial is lacking.



Objective of the study:

This study aims to evaluate the impact of UAE on Quality of life (QOL) in comparison to hysterectomy in adenomyosis patients. A cost-effectiveness study will be part of the trial as well as a cohort hysterectomy group to clearify imaging and diagnosis of adenomyosis.

The original protocol described a randomized controlled trial where eligible patients (not changed) were randomized to either hysterectomy or UAE in a 1:2 ratio. Inclusion rates were disappointing, resulting in very low progress of the trial. Therefore a new design was chosen: a case-control design with retrospective matching (or correction of baseline variables if not identical at baseline).



Study design:

2015-2018: Non-blinded randomized controlled trial and cohort alongside the trial.
2018-2021: case-control cohort study



Study population:

Premenopausal women without the desire to conceive and who have symptomatic MRI confirmed pure adenomyosis or dominant adenomyosis in combination with fibroids. (If the deep fibroids are clearly less to the extent of adenomyosis in terms of volume we consider it dominant adenomyosis)



Intervention (if applicable):

UAE, performed by experienced interventional radiologists versus hysterectomy (laparoscopically, abdominally or vaginally).



Primary study parameters/outcome of the study:

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.

Secundary study parameters/outcome of the study (if applicable):

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.

This study aims to evaluate the impact of UAE on Quality of life (QOL) in comparison to hysterectomy in adenomyosis patients.

Measurements: will be taken at baseline and 6, 12, 26, 52 and 104 weeks after therapy.

Uterine artery embolization -> experimental treatment

Hysterectomy -> standard care