Comparison of Pain of Two Different Methods in Uterine Artery Embolization

Yonsei University

Status: Completed

Conditions: Leiomyoma

Treatments: Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere

Study type: Interventional

Funder types: Other

Identifiers

NCT03420248

4-2016-1108

Details and patient eligibility

About

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

Full 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

Enrollment: 54 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups

Non-spherical polyvinyl alcohol particle

Experimental group

Description:

For embolic material, non-spherical polyvinyl alcohol particle is used.

Treatment:

Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere

Tris-acryl gelatin microsphere

Experimental group

Description:

For embolic material, Tris-acryl gelatin microsphere is used.

Treatment:

Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere