Comparison of Pain of Two Different Methods in Uterine Artery Embolization

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

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

Study Overview

• Status: Completed
• Conditions: Leiomyoma
• Intervention / Treatment: Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Sesverance Hospital, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Severance Hospital
• Investigators: Principal Investigator: So Yeon Kim, MD, PhD, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine; Principal Investigator: Man Deuk Kim, MD, PhD, Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): February 8, 2019
• Study Completion (Actual): May 8, 2019

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: 4-2016-1108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No