Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis

September 12, 2023 updated by: Yonsei University

Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis: A Randomized Controlled Trial Comparing Therapeutic Efficacy

The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Screening

  • History, Physical examination
  • Laboratory test (Hemoglobin) / MRI
  • Pictorial blood loss assessment chart
  • Symptom/Quality of life score

Intervention

  • Intrauterine device or uterine artery embolization
  • Adverse event montoring

Follow-up visit #1 (1 month)

  • Vital signs
  • blood test (Hemoglobin) / Ultrasound
  • Adverse event monitoring

Follow-up visit #2 (3 month)

• MRI only for embolization patients

Follow-up visit #3 (6 months)

  • Blood test (Hemoglobin) / Ultrasound
  • Pictorial blood loss assessment chart
  • Symptom/Quality of life score

Follow-up visit #4 (12months)

  • Blood test (Hemoglobin) / Ultrasound
  • Pictorial blood loss assessment chart
  • Symptom/Quality of life score

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Man-Deuk Kim
  • Phone Number: 82-10-8625-2197
  • Email: mdkim@yuhs.ac

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. Women with symptomatic fibroids (age: 19 - 48 years old) 2. Hemglobin < 12g/dL, 3. Symptoms of adenomysis (Menorrhagia, Dysmenorrhea)

Exclusion Criteria:

1. Gynecologic malignancy 2. Ongoing infection or inflammation 3. Coagulopathy (platelet < 50,000 or INR > 1.5) 4. Concomitant endometriosis 5. Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intrauterine device
Procedure: Intrauterine device
The vagina is visually inspected to check the size and position of the uterus. The speculum is inserted into the vagina. The IUD is placed inside the uterus and then the strings are cut.
Active Comparator: Uterine artery embolization
Procedure: Uterine artery embolization
The right common femoral artery is punctured under ultrasound guidance and a 5F vascular sheath is inserted into the Rt common femoral artery. A 5F catheter was inserted into the internal iliac artery, and a 2.0F microcatheter is advanced into the uterine artery. Embolization is performed using polyvinyl alcohol (PVA). One third (20 mL) of a 60-mL mixture comprising 150-250-µm PVA particles was injected at the beginning of embolization into each uterine artery, followed by injection of at least two thirds (40 mL) to all (60 mL) of a mixture comprising 250-355- µm PVA particles and finally completion with 355-500- µm PVA particles. Embolization was performed until complete cessation of blood flow in the ascending uterine artery for 10 heart beats.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin level
Time Frame: Hemoglobin level at 6 and 12 months after each procedure
Hemoglobin as an indicator of menstrual bleeding
Hemoglobin level at 6 and 12 months after each procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pictorial blood loss assessment chart (PBAC)
Time Frame: 0,6,12 months
Pictorial blood loss assessment chart: a semi-quantitative method for evaluation of menstrual blood loss (>100 considered as heavy mentrual blood)
0,6,12 months
Visual analogue scale
Time Frame: 0,6,12 months
Visual analogue scale: a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
0,6,12 months
Symptom and quality of life score questionnaire
Time Frame: 0,6,12 months
Symptom and quality of life score questionnaire: a questionnaire developed to objectively assess symptom severity and quality of life in relation to uterine adenomyosis before and after procedure
0,6,12 months
Uterine volume
Time Frame: 0,12 months
0,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2023-0729

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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