Clinical trial NCT05597644: Role of Uterine Artery Embolization in Adenomyosis
Official title: Role of Uterine Artery Angioembolization in Management of Uterine Adenomyosis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Adenomyosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Angioembolization of uterine artery by PVA particles
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: uterine artery embolization in management of adenomyosis
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ehab Mansour, Assistant Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Abd ElKareem Hasan, Professor
role: STUDY_CHAIR
References: