Efficacy of Ultrasound Guided Microwave Ablation in the Treatment of Uterine Fibroids. (MWAUF)

November 16, 2025 updated by: Jihad Hussien Mohamed Mahmoud

Uterine fibroids are the most common benign tumors of the female genital tract and can significantly affect the quality of life in reproductive-age women, causing symptoms such as heavy menstrual bleeding, pelvic pressure, urinary disturbances, dyspareunia, and infertility. Traditional surgical interventions such as myomectomy and hysterectomy remain the standard of care, yet they are associated with considerable trauma, longer recovery times, and the loss of uterine function.

Microwave ablation (MWA) is a minimally invasive image-guided technique that uses microwave energy to induce coagulative necrosis in fibroid tissue, reducing its size and alleviating symptoms while preserving the uterus. This study aims to evaluate the feasibility, safety, and therapeutic effectiveness of ultrasound-guided percutaneous microwave thermal ablation (PMTA) in the management of symptomatic uterine fibroids.

Eligible participants are premenopausal women aged 25 years or older with symptomatic fibroids less than 10 cm in size and fewer than five in number. Exclusion criteria include pregnancy, bleeding disorders, chronic diseases contraindicating anesthesia, and ongoing anticoagulant therapy.

Each participant will undergo ultrasound-guided microwave ablation under aseptic conditions and sedation. Fibroid size, menstrual bleeding patterns, hemoglobin levels, and pain scores will be evaluated at baseline and during follow-up at 3 and 6 months. The primary outcome is the reduction in fibroid size, while secondary outcomes include symptom improvement and hemoglobin level changes.

This prospective case series will be conducted at Assiut University Hospitals, Egypt, with 20 participants referred from the Gynecology Department to the Interventional Radiology Unit. The results will provide valuable data on the clinical value of MWA as a uterus-preserving alternative for symptomatic uterine fibroids.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective interventional study will investigate the efficacy and safety of ultrasound-guided microwave ablation (MWA) for the treatment of uterine fibroids in premenopausal women who wish to avoid hysterectomy.

Fibroids are a leading cause of gynecologic morbidity and the most common indication for hysterectomy worldwide. Although medical and surgical therapies exist, many patients experience suboptimal outcomes or prefer minimally invasive, uterus-sparing treatments. MWA offers a promising alternative, providing precise thermal destruction of fibroid tissue through localized energy deposition with minimal collateral damage.

In this study, 20 women diagnosed with symptomatic uterine fibroids meeting inclusion criteria will be recruited. After pre-procedural evaluation-including clinical assessment, imaging, and laboratory testing-patients will undergo percutaneous MWA under ultrasound guidance. A microwave needle (1.4-1.6 mm in diameter and 15-20 cm in length) will be inserted into the fibroid, and thermal ablation will be applied for 10-30 minutes depending on lesion characteristics.

Post-procedure monitoring will include ultrasound assessment for immediate complications, with follow-up visits at 3 and 6 months to evaluate changes in fibroid size, menstrual characteristics, pain, and hemoglobin levels.

Statistical analysis will include descriptive measures and comparative tests (chi-square, t-test, or Wilcoxon rank-sum). Significance will be set at p ≤ 0.05. Data will be analyzed using STATA 13.

The study is conducted in compliance with the Declaration of Helsinki and has received ethical approval from the Assiut University Faculty of Medicine Ethics Committee. Written informed consent will be obtained from all participants prior to inclusion.

The expected outcome is to demonstrate that ultrasound-guided MWA is a feasible, safe, and effective minimally invasive therapy for uterine fibroids, potentially improving patient quality of life while avoiding the morbidity associated with hysterectomy and other surgical interventions.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Assiut Governorate
      • Asyut, Assiut Governorate, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Female patients aged 25 years or older Good general health Symptomatic uterine fibroids suitable for microwave ablation as determined by examining gynecologist Premenopausal status Acceptable risks for general anesthesia or sedation Number of fibroids: fewer than 5 Size of fibroid: less than 10 cm

Exclusion Criteria:

Ongoing anticoagulant treatment and/or known bleeding disorder Chronic diseases contraindicating general anesthesia Pregnancy Postmenopausal status 5 or more fibroids Fibroid size 10 cm or larger Poor general health precluding anesthesia or sedation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microwave Ablation Treatment
Patients with symptomatic uterine fibroids who meet inclusion criteria will undergo ultrasound-guided percutaneous microwave thermal ablation (PMTA). The procedure involves percutaneous insertion of a microwave needle (1.4 to 1.6mm diameter and 15 to 20 cm length) into the fibroid under US guidance, with thermal ablation continuing for 10 to 30 minutes under IV sedation. Patients will be followed at 3 and 6 months to assess fibroid size reduction and symptom improvement.
Procedure: Ultrasound-Guided Percutaneous Microwave Thermal Ablation
Minimally invasive percutaneous microwave thermal ablation of symptomatic uterine fibroids performed under ultrasound guidance. After 8 hours fasting and under aseptic conditions with IV sedation, a microwave needle (1.4-1.6mm diameter, 15-20cm length depending on fibroid site and size) is inserted percutaneously into the fibroid under ultrasound guidance. Thermal ablation is performed for 10-30 minutes to achieve coagulation necrosis of the fibroid tissue. Patients are discharged after several hours with post-procedure antibiotics and analgesics. Follow-up assessments at 3 and 6 months include ultrasound imaging, hemoglobin levels, and symptom evaluation.
Other Names:
  • Microwave Ablation
  • MWA
  • PMTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Uterine Fibroid Size
Time Frame: Baseline, 3 months, and 6 months post-intervention
Assessment of uterine fibroid dimensions (volume/diameter) measured by ultrasound imaging to evaluate the effectiveness of microwave ablation in reducing fibroid size.
Baseline, 3 months, and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Menstrual Bleeding
Time Frame: Baseline, 3 months, and 6 months post-intervention
Assessment of menstrual bleeding severity measured by the number of pads/diapers used during menses and the number of days of menstruation.
Baseline, 3 months, and 6 months post-intervention
Change in Hemoglobin Level
Time Frame: Baseline and 6 months post-intervention
Assessment of hemoglobin (Hb) level through complete blood count (CBC) to evaluate improvement in anemia related to fibroid-associated bleeding.
Baseline and 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jihad Hussien Mohamed Mahmoud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ultrasound in uterine fibroids

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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