Role of Uterine Artery Embolization in Adenomyosis

Role of Uterine Artery Angioembolization in Management of Uterine Adenomyosis.

Management of symptomatizing women diagnosed with uterine adenomyosis, by uterine artery angioembolization as a minimally invasive replacement for hysterectomy. This is followed by assessment of the symptoms and MRI of the pelvis after 3 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Adenomyosis
• Intervention / Treatment: Procedure: Trans-arterial uterine artery embolization

Detailed Description

Adenomyosis is defined by the abnormal location of endometrial tissue within the myometrium associated with hypertrophy or hyperplasia of the myometrial stroma. Although pathogenesis and etiology of adenomyosis remain unknown, two main theories have been proposed: invagination of the endometrial basal layer and metaplasia of embryonic stem cells. Despite the absence of specific (pathognomonic) diagnostic features for uterine adenomyosis, typical symptoms include menorrhagia, chronic pelvic pain, and dysmenorrhea.

For more than a century, diagnosis was dependent on histopathologic examination of post-hysterectomy specimens till the introduction of noninvasive ultrasound and MR techniques. Since then, several studies have illustrated high sensitivities and specificities for both two-dimensional transvaginal sonography (TVS) and magnetic resonance imaging (MRI). Current treatment options for symptomatic adenomyosis include hysterectomy, medication, conservative surgery, or minimally invasive techniques including uterine artery embolization. To date, hysterectomy remains the definitive treatment. This is mainly due to difficult diagnosis, the diffuse nature of the disease, and little evidence-based literature needed to standardize treatments. This consequently results in a management dilemma, particularly in symptomatic patients who wish to preserve their uterus.

Uterine artery embolization is the use of transarterial catheters aiming to induce more than 34% necrosis within adenomyotic tissues. Vascular access is gained through a femoral or radial artery puncture using 4-6-French (F) arterial sheath for femoral and 4-F sheath for radial access. Under fluoroscopic guidance, aortography is followed by selective and super selective arteriography using 4-5-F catheters for the internal iliac and 2-3-F microcatheters for the uterine artery and its branches respectively. Embolization is usually performed using variable-sized permanent particulate agents.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Moustafa Al-Hussaini, Specialist; Phone Number: 01023646463; Email: moustafa71989@gmail.com
• Study Contact Backup: Name: Mahmoud Refaat, Lecturer; Phone Number: 01003133736; Email: mahmoud.abdelzaher@med.au.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Symptomatizing women (pelvic pain and/or bleeding) between ages 30-50 who are not keen on hysterectomy.

Exclusion Criteria:

• Women who desire further child bearing (not completed their family yet).
• Impaired coagulation profile.
• Hypersensitivity to intravenous contrast media.
• Decompensated congestive heart failure.
• Hypertensive crisis.
• Stroke or CVA.
• Renal failure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: females with adenomyosis	Procedure: Trans-arterial uterine artery embolization; transarterial angioembolization of uterine artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
uterine artery embolization in management of adenomyosis	study the effect of embolization on symptoms and imaging findings	baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Ehab Mansour, Assistant Professor, Assiut University; Study Chair: Abd ElKareem Hasan, Professor, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): October 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Adenomyosis
• Other Study ID Numbers: UAE in adenomyosis

Drug and device information, study documents

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