Role of Uterine Artery Embolization in Adenomyosis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05597644
Collaborator
(none)
30
1
35

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Trans-arterial uterine artery embolization
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Angioembolization of uterine artery by PVA particlesAngioembolization of uterine artery by PVA particles
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Role of Uterine Artery Angioembolization in Management of Uterine Adenomyosis.
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: females with adenomyosis

Procedure: Trans-arterial uterine artery embolization
transarterial angioembolization of uterine artery

Outcome Measures

Primary Outcome Measures

  1. uterine artery embolization in management of adenomyosis [baseline]

    study the effect of embolization on symptoms and imaging findings

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Moustafa Tarek Khalaf Al-Hussaini, Specialist, Assiut University
ClinicalTrials.gov Identifier:
NCT05597644
Other Study ID Numbers:
  • UAE in adenomyosis
First Posted:
Oct 28, 2022
Last Update Posted:
Oct 28, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2022