QUality of life after Embolization vs. hySTerectomy in Adenomyosis.
Recruiting
- Registration Number
- NL-OMON23586
- Lead Sponsor
- VU Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
•Premenopausal women with MRI confirmed symptomatic adenomyosis or dominant adenomyosis in combination with fibroids.
• Premenopausal women with an indication for hysterectomy.
Exclusion Criteria
•Younger than 18 years of age
•Pelvic infection/Suspicion or presence of malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Quality of life: <br>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)</p>
- Secondary Outcome Measures
Name Time Method <p>The two treatments will also be compared in terms of:<br>• Clinical outcomes (PBAC, NRS 0-100 scale, Facet 1:Pain and discomfort WHOQOL-100, Satisfaction with allocated treatment (likert-scale), patient preference) <br>• Recovery related outcomes (RI-10)<br>• Quality of life outcomes (HOQOL-Bref and SF-12) <br>• Cost outcomes (EQ-5D)<br>• Imaging outcomes (uterine size reduction, infarction rate, junctional zone reduction, concomitant fibroids)</p>