Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis

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

Detailed Description
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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

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

Conditions
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Adenomyosis

Intervention / Treatment
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* Procedure: Intrauterine device
* Procedure: Uterine artery embolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrauterine device<br> | Procedure: Intrauterine device<br>* 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.<br>|
| Active Comparator: Uterine artery embolization<br> | Procedure: Uterine artery embolization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level | Hemoglobin as an indicator of menstrual bleeding | Hemoglobin level at 6 and 12 months after each procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 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 | 0,6,12 months | 
| Uterine volume |  | 0,12 months |