Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis

Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis: A Randomized Controlled Trial Comparing Therapeutic Efficacy

The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.

Screening History, Physical examination Laboratory test (Hemoglobin) / MRI Pictorial blood loss assessment chart Symptom/Quality of life score Intervention Intrauterine device or uterine artery embolization Adverse event montoring Follow-up visit #1 (1 month) Vital signs blood test (Hemoglobin) / Ultrasound Adverse event monitoring Follow-up visit #2 (3 month) • MRI only for embolization patients Follow-up visit #3 (6 months) Blood test (Hemoglobin) / Ultrasound Pictorial blood loss assessment chart Symptom/Quality of life score Follow-up visit #4 (12months) Blood test (Hemoglobin) / Ultrasound Pictorial blood loss assessment chart Symptom/Quality of life score

The vagina is visually inspected to check the size and position of the uterus. The speculum is inserted into the vagina. The IUD is placed inside the uterus and then the strings are cut.

The right common femoral artery is punctured under ultrasound guidance and a 5F vascular sheath is inserted into the Rt common femoral artery. A 5F catheter was inserted into the internal iliac artery, and a 2.0F microcatheter is advanced into the uterine artery. Embolization is performed using polyvinyl alcohol (PVA). One third (20 mL) of a 60-mL mixture comprising 150-250-µm PVA particles was injected at the beginning of embolization into each uterine artery, followed by injection of at least two thirds (40 mL) to all (60 mL) of a mixture comprising 250-355- µm PVA particles and finally completion with 355-500- µm PVA particles. Embolization was performed until complete cessation of blood flow in the ascending uterine artery for 10 heart beats.

Pictorial blood loss assessment chart: a semi-quantitative method for evaluation of menstrual blood loss (>100 considered as heavy mentrual blood)

Visual analogue scale: a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.

Symptom and quality of life score questionnaire: a questionnaire developed to objectively assess symptom severity and quality of life in relation to uterine adenomyosis before and after procedure

Inclusion Criteria: 1. Women with symptomatic fibroids (age: 19 - 48 years old) 2. Hemglobin < 12g/dL, 3. Symptoms of adenomysis (Menorrhagia, Dysmenorrhea) Exclusion Criteria: 1. Gynecologic malignancy 2. Ongoing infection or inflammation 3. Coagulopathy (platelet < 50,000 or INR > 1.5) 4. Concomitant endometriosis 5. Pregnancy