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

Recruiting

• Conditions: Adenomyosis; endometrium in uterine wall muscle.; 10038595; 10003184

• Registration Number: NL-OMON55436
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

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

• 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: quality of life as measured by a combination of the World<br /><br>Health Organization Quality-of-Life Scale (WHOQOL-Bref) and short-form-12<br /><br>(SF-12) questionnaire at 26 weeks after therapy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The two treatments will also be compared in terms of Clinical outcomes,<br /><br>Recovery related outcomes, Quality of life outcomes and cost outcomes. Also<br /><br>imaging outcomes will be investigated at baseline in order to identify<br /><br>potential predictive parameters for therapy effect. </p><br>