Comparing Efficacy of Microwave Vs Embolization Treatment for Adenomyosis
Single Blinded Randomized Controlled Study of Symptom Improvement After Uterine Artery Embolization (UAE) Versus Ultrasound Guided Percutaneous/transvaginal Microwave Ablation, Evaluated by Validated Questionnaires
Karolinska Institutet
70 participants
Sep 16, 2020
INTERVENTIONAL
Conditions
Summary
Single blinded randomized controlled study of symptom improvement after uterine artery embolization (UAE) versus ultrasound guided percutaneous/transvaginal microwave ablation, evaluated by validated questionnaires. Adenomyosis is a benign condition causing pain and bleeding disorders in many women. Hysterectomy has historically been the golden standard for treatment as well as (postoperatively) diagnosis of the disease. In accordance with refined diagnostic tools such as ultrasound and/or MRI, minimally invasive treatments for adenomyosis are being explored. We plan to compare two minimally invasive techniques: embolization of the uterine artery (a commonly used procedure) and microwave ablation of adenomyotic tissue (previously only in clinical use in China).
Eligibility
Inclusion Criteria4
- Healthy women aged 30-55 with symptomatic adenomyosis
- Premenopausal
- Adenomyosis diagnosted by TVUS
- Willing to comply with protocol
Exclusion Criteria3
- Body Mass Index >35
- Treatment with anticoagulant/bleeding disorder
- Contraindication for UAE or general anesthesia
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Interventions
Microwave treatment via needle antenna, (Emprint Covidien microwave ablation system) either percutaneous or vaginally administrated
Embolization via percutaneous catheter
Locations(1)
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NCT04209127