Adenomyosis
Conditions
Brief summary
The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.
Detailed description
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
Interventions
PROCEDUREIntrauterine device
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.
PROCEDUREUterine artery embolization
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 48 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin level | Hemoglobin level at 6 and 12 months after each procedure | Hemoglobin as an indicator of menstrual bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pictorial blood loss assessment chart (PBAC) | 0,6,12 months | Pictorial blood loss assessment chart: a semi-quantitative method for evaluation of menstrual blood loss (\>100 considered as heavy mentrual blood) |
| Visual analogue scale | 0,6,12 months | 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 | 0,6,12 months | 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 |
| Uterine volume | 0,12 months | — |
Countries
South Korea
Contacts
Primary ContactMan-Deuk Kim
Outcome results
None listed