Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis

This single-center, single-arm, open-label study evaluates the efficacy and safety of ultrasound-guided radiofrequency ablation (RFA) in women with symptomatic focal adenomyosis who wish to preserve the uterus. RFA is performed transvaginally under general anesthesia using the Myoblate system. Participants are followed at 3, 6 and 12 months (optionally 24 months) with transvaginal ultrasound and validated questionnaires (VAS, PBAC, EQ-5D-5L). The primary outcomes are the changes in pain severity and menstrual blood loss at 6 and 12 months compared with baseline.

Inclusion Criteria: * Women aged 18 years or older with focal (circumscribed) adenomyosis confirmed by transvaginal ultrasound (TVUS) and described using MUSA terminology * Symptoms (dysmenorrhea and/or heavy menstrual bleeding) persisting despite conservative treatment or intolerance of conservative treatment * Wish to preserve the uterus * Signed informed consent and consent to personal data processing Exclusion Criteria: * Pregnancy (excluded by pregnancy test before the procedure) or planned pregnancy during the study; suspected malignancy; active pelvic infection; intrauterine device in situ * Contraindication to the procedure or anesthesia according to the investigator * Known history or intraoperatively suspected endometriosis, or significant pelvic adhesions * Start or change of hormonal treatment of adenomyosis within 6 months before enrollment * Inability to understand the patient information or to complete the questionnaires independently; current participation in another interventional study