Comparison of Pain of Two Different Methods in Uterine Artery Embolization

Study Overview
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Brief Summary
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The primary purpose of this study is to compare pain after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Detailed Description
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Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE remains a major problem. The non-spherical polyvinyl alcohol particle and tri-acryl gelatin microsphere are two embolic materials used for UAE.Therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Official Title
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Comparison of Pain After Uterine Artery Embolization Using Non-spherical Polyvinyl Alcohol Particles or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids

Conditions
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Leiomyoma

Intervention / Treatment
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* Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uterine artery embolization due to multiple fibroids Exclusion Criteria: Severe liver or kidney dysfunction Drug allergy Bradycardia (<45 bpm) or heart block Uncontrolled hypertension

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-spherical polyvinyl alcohol particle<br>For embolic material, non-spherical polyvinyl alcohol particle is used. | Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere<br>* One of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same.<br>|
| Experimental: Tris-acryl gelatin microsphere<br>For embolic material, Tris-acryl gelatin microsphere is used. | Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere<br>* One of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity by numerical rating scale | 0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable | 0-24 h after UAE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein | mg/L | 24 h after UAE | 
| White blood cell count | /uL | 24 h after UAE | 
| Neutrophil percentage |  | 24 h after UAE | 
| Neutrophil-to-lymphocyte ratio |  | 24 h after UAE | 
| Platelet-to-lymphocyte ratio |  | 24 h after UAE | 
| Mean platelet volume | fL(femtolitre) | 24 h after UAE | 
| Sucessful rate at 3 month after UAE measured by MRI | Complete necrosis incidence | 3 month after UAE |