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

NCT06652945 | Not Yet Recruiting

• 1 other identifier: Uterine Artery Embolization
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Uterine Adenomyosis

Outcome Measures

Primary Outcomes (1)

• Management of symptomatic uterine adenomyosis

  Relieving the symptoms of uterine adenomyosis using uterine artery embolization such as abnormal uterine bleeding and dysmenorrhea

  three years

Study Arms (1)

Symptomatic uterine adenomyosis

EXPERIMENTAL

Patients with symptomatic uterine adenomyosis

Other: Uterine artery embolization

Interventions

Uterine artery embolization OTHER

Uterine artery embolization under fluoroscopy

Also known as: Fluoroscopy, polyvinyl alcohol (PVA)

Symptomatic uterine adenomyosis

Eligibility Criteria

• Age: 35 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Adenomyosis

Interventions

Uterine Artery Embolization; Polyvinyl Alcohol

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Alcohols; Organic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Sara Mohamed

CONTACT

+201098349966; sara.gamal93@aun.edu.eg

Sayed Hassaneen, Doctor

CONTACT

+201064881044; drsayed121@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 22, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share