Efficacy of Uterine Artery Embolization (UAE) in Management of Symptomatic Uterine Adenomyosis

Aim of the work:

Evaluating the efficiency of uterine artery embolization as a minimally invasive method of treatment in management of symptomatic women with uterine adenomyosis

Study Overview

• Status: Not yet recruiting
• Conditions: Uterine Adenomyosis
• Intervention / Treatment: Other: Uterine artery embolization

Detailed Description

Adenomyosis is defined as a non-neoplastic disease, caused by benign invasion of the myometrial layer by endometrial tissue, associated with myometrial smooth muscle hyperplasia. This ectopic endometrium shows two main patterns of distribution in the myometrium: either focal endometrial implant of endometrial glands, or diffuse invasion of the myometrium. Uterine enlargement is often seen with diffuse adenomyosis, while in cases with focal adenomyosis, characteristic feature in ultrasound (US) can be misdiagnosed as leiomyoma, appearing as focal heterogeneous myometrial thickening or myometrial cysts.

Usually, adenomyosis is presented with dysmenorrhea, menorrhagia, and abnormal uterine bleeding. Previously, adenomyosis was diagnosed in multiparous women older than 40 years, causing abnormal uterine bleeding (AUB). But recently, it has been widely recognized among larger group, including nulliparous women earlier in reproductive life, owing to increased availability and better imaging techniques.

The first imaging modality to diagnose adenomyosis is transabdominal sonography (TAS) or transvaginal sonography (TVS). While magnetic resonance (MR) imaging is considered the gold standard diagnosis method due to its accuracy; being noninvasive modality and its ability for better soft tissue characterization to differentiate adenomyosis from other pathologies.

First line of management of adenomyosis include medications as non-steroidal anti-inflammatory drugs and/or hormonal therapy. Yet, other methods of treatment are needed in different cases.

For many years, the most common line of treatment for symptomatic uterine adenomyosis is hysterectomy. Some studies discussed the possibility of uterine-sparing surgeries to treat adenomyosis, despite the controversy of application. Many patients prefer uterine-sparing lines of treatment over hysterectomy, especially after failure of medical treatment. Recent studies have been investigating uterine artery embolization (UAE) as a promising line of treatment of adenomyosis.

In 1995, the study of Ravina was the first to discuss UAE. Ever since, UAE was established as a treatment option for symptomatic patients with adenomyosis, as well as uterine fibroids, owing to its earliest positive results. The objective of UAE is to produce more than 34% necrosis of adenomyotic tissues, using trans-arterial catheters. Recent studies show increasing success rates of managing adenomyosis using UAE, with rates ranging from 60% to 70% and from 72% to 94.3%, respectively.

To evaluate uterine volume and areas of necrosis, patients are referred to perform MRI following the UAE, as in cases with fibroid disease. With regard of different symptoms and presentations of adenomyosis, having a cut-off value to evaluate effectiveness of the procedure to alleviate the symptoms is considered challenging.

Some major complications and side effects can occur such as infections, and pain caused by ischemic necrosis, especially the first hours after the procedure which require strong regimen for pain control. Six percent of the cases complained of persistent amenorrhea, and they were above the age of 40 years old.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Mohamed; Phone Number: +201098349966; Email: sara.gamal93@aun.edu.eg
• Study Contact Backup: Name: Sayed Hassaneen, Doctor; Phone Number: +201064881044; Email: drsayed121@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Premenopausal women
• Symptomatic pure adenomyosis or dominant adenomyosis when both adenomyosis and fibroids coexist
• Women with an indication for hysterectomy (either failed or refused medical treatment).

Exclusion Criteria:

• Patients under 18 years of age,
• Patients with pelvic infection,
• Suspected or confirmed malignancy
• Current or future desire to conceive
• Deep infiltrating endometriosis requiring surgery or obstructing the bowel, or
• Coexisting hysteroscopically removable submucous fibroids
• Any absolute contraindication to angiography such as:
• hypersensitivity to intravenous contrast media,
• impaired coagulation profile or
• impaired renal function.

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: Symptomatic uterine adenomyosis; Patients with symptomatic uterine adenomyosis	Other: Uterine artery embolization; Uterine artery embolization under fluoroscopy; Other Names: Fluoroscopy; polyvinyl alcohol (PVA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Management of symptomatic uterine adenomyosis	Relieving the symptoms of uterine adenomyosis using uterine artery embolization such as abnormal uterine bleeding and dysmenorrhea	three years

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Adenomyosis
• Other Study ID Numbers: Uterine Artery Embolization

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No