What is Sonata for treating uterine fibroids?

Sonata System for Uterine Fibroids

The Sonata System is a minimally invasive, transcervical radiofrequency ablation treatment for uterine fibroids that combines intrauterine ultrasound guidance with radiofrequency energy to ablate fibroids without incisions, offering significant symptom improvement and uterine preservation. 1, 2

How the Sonata System Works

• The Sonata System uses transcervical radiofrequency ablation (TFA) technology to treat fibroids
• It incorporates real-time intrauterine sonography to visualize and target fibroids
• The procedure is performed through the cervix without surgical incisions
• It preserves the uterus and is designed for outpatient treatment
• The system can treat multiple types of fibroids, particularly those with intramural components

Clinical Effectiveness

• Studies show significant reduction in fibroid volume:

  • 73.3% median reduction in total and perfused fibroid volume at 12 months 2
  • Significant decrease in fibroid diameter from 41mm to 29mm (median) after treatment 3

• Symptom improvement:

  • 72.3% reduction in menstrual bleeding at 12 months 2
  • 62.5% reduction in symptom severity at 12 months 2
  • 86% of patients with fibroids ≥5cm reported symptom improvement 1
  • Significant improvement in health-related quality of life (127% increase at 12 months) 2

• The SONATA pivotal trial showed sustained benefits at 2 years:

  • Symptom severity decreased from 55 to 24 points
  • Health-related quality of life increased from 40 to 83 points
  • 94% overall treatment satisfaction at 2 years 4

Advantages

• Incisionless procedure that preserves the uterus
• Can be performed on an outpatient basis
• Does not require general anesthesia
• Rapid recovery and return to normal activities
• Effective for fibroids of various sizes (1-12cm documented) 1
• Can treat multiple fibroids in a single session

Limitations and Considerations

• Reintervention rates should be discussed:

  • 24.5% at 1 year and 39.8% at 2 years in one long-term study 3
  • 5.5% surgical reintervention rate for heavy menstrual bleeding through 2 years in the SONATA trial 4

• Not all fibroids may be accessible or appropriate for this treatment

• Limited long-term data compared to established treatments like UAE or myomectomy

• Rare but serious complications have been reported:

  • Case report of bacterial sepsis and Asherman's syndrome as complications 5

Patient Selection

The Sonata System may be most appropriate for:

• Women seeking uterine-preserving treatment
• Those with symptomatic fibroids (heavy bleeding, bulk symptoms)
• Patients who prefer minimally invasive options
• Those wishing to avoid longer recovery associated with surgical approaches

Comparison to Other Treatments

• Unlike Uterine Artery Embolization (UAE), Sonata directly targets fibroids rather than blocking blood supply 6
• Unlike myomectomy, no surgical incisions are required
• Unlike hysterectomy, the uterus is preserved
• The procedure offers shorter hospitalization and faster recovery compared to surgical approaches 6

While the Sonata System represents a promising addition to fibroid treatment options, patient selection should be based on fibroid characteristics, symptom profile, and future fertility desires. The risk of reintervention should be discussed when counseling patients about this treatment option.