QUality of life after Embolization vs. hySTerectomy in Adenomyosis.

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23586

Enrollment

Registered

2016-02-17

Start date

2015-11-17

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. S

Interventions

Uterine artery embolization -> experimental treatment Hysterectomy -> standard care

Eligibility

Inclusion criteria

Inclusion criteria: • Premenopausal women with MRI confirmed symptomatic adenomyosis or dominant adenomyosis in combination with fibroids. • Premenopausal women with an indication for hysterectomy. • No wish to conceive in the present or future • Able to understand Dutch 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
• Quality of life:  To demonstrate non inferiority of treatment of adenomyosis with uterine artery embolization compared to treatment by hysterectomy in terms of quality of life at 26, 52 and 104 weeks after treatment (measured by WHOQOL-Bref and SF-12)	—

Secondary

Measure	Time frame
The two treatments will also be compared in terms of: • Clinical outcomes (PBAC, NRS 0-100 scale, Facet 1:Pain and discomfort WHOQOL-100, Satisfaction with allocated treatment (likert-scale), patient preference)  • Recovery related outcomes (RI-10) • Quality of life outcomes (HOQOL-Bref and SF-12)  • Cost outcomes (EQ-5D) • Imaging outcomes (uterine size reduction, infarction rate, junctional zone reduction, concomitant fibroids)	—

Measure

Time frame

The two treatments will also be compared in terms of: • Clinical outcomes (PBAC, NRS 0-100 scale, Facet 1:Pain and discomfort WHOQOL-100, Satisfaction with allocated treatment (likert-scale), patient preference)  • Recovery related outcomes (RI-10) • Quality of life outcomes (HOQOL-Bref and SF-12)  • Cost outcomes (EQ-5D) • Imaging outcomes (uterine size reduction, infarction rate, junctional zone reduction, concomitant fibroids)

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Contacts

Public ContactMarissa Harmsen

Arts-onderzoeker QUESTA-studie www.questa-studie.nl

m.harmsen1@amsterdamumc.nlT: +3120 44 44833/ +31683674927

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)