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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03420248

Enrollment

Registered

2018-02-05

Start date

2018-04-19

Completion date

2019-05-08

Last updated

2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leiomyoma

Brief 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

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

Interventions

DEVICENon-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026