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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
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.
Severance hospital
Seoul, South Korea
RECRUITINGHemoglobin level
Hemoglobin as an indicator of menstrual bleeding
Time frame: Hemoglobin level at 6 and 12 months after each procedure
Pictorial blood loss assessment chart (PBAC)
Pictorial blood loss assessment chart: a semi-quantitative method for evaluation of menstrual blood loss (\>100 considered as heavy mentrual blood)
Time frame: 0,6,12 months
Visual analogue scale
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.
Time frame: 0,6,12 months
Symptom and quality of life score questionnaire
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
Time frame: 0,6,12 months
Uterine volume
Time frame: 0,12 months
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