Comparison of Pain of Two Different Methods in Uterine Artery Embolization

Leiomyoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420248
• Other study ID #: 4-2016-1108
• Status: Completed
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: May 8, 2019

Study information

• Verified date: September 2019
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Sesverance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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