Uterine artery embolization versus hysterectomy for symptomatic adenomyosis: a case-control study

Adenomyosis is defined as the benign invasion of endometrial stroma and glands
in the myometrium, surrounded by hypertrophic and hyperplastic myometrium.
Today adenomyosis still poses a gynaecological challenge. There are differences
in opinion and thus differences in definition, diagnosing as well a treatment
options.
Adenomyosis is frequently suspected in patients with abnormal uterine bleeding
and dysmenorrhea and diagnosed in the uterine specimen of patients with
presumed uterine fibroids. Due to improved quality of imaging techniques the
accuracy to detect adenomyosis compared to histology has increased.
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.

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.

Case-control study

Protocol change
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. Although randomized data are strongest, a case control study still
renders the best evidence in this field, since no comparative study has been
performed so far. This protocol has been changed (with track changes) to the
new design.

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

Both UAE and hysterectomy are performed for symptomatic adenomyosis. There is
ample experience with UAE, both for symptomatic uterine fibroids and
post-partum haemorrhage. Also, adenomyosis embolization has been performed in
numerous case series. A comparative study with hysterectomy has never been made
with any other treatment. Therefore, this study is about efficacy and not about
safety. There are no specific risks as women who are willing to conceive are
excluded. The specific risks that apply to the treatment are described above
(E9).