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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorJihad Hussien Mohamed Mahmoud

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Ultrasound-Guided Percutaneous Microwave Thermal Ablation

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Microwave Ablation TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Uterine Fibroid Size

Assessment of uterine fibroid dimensions (volume/diameter) measured by ultrasound imaging to evaluate the effectiveness of microwave ablation in reducing fibroid size.

Time frame
Baseline, 3 months, and 6 months post-intervention

Secondary outcomes

1

Change in Menstrual Bleeding

Assessment of menstrual bleeding severity measured by the number of pads/diapers used during menses and the number of days of menstruation.

Time frame
Baseline, 3 months, and 6 months post-intervention
2

Change in Hemoglobin Level

Assessment of hemoglobin (Hb) level through complete blood count (CBC) to evaluate improvement in anemia related to fibroid-associated bleeding.

Time frame
Baseline and 6 months post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jihad Hussien Mohamed Mahmoud

Lead sponsor

Assiut University

Sponsor institution

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