The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids

Abstract The FAST-EU Trial was designed to establish the effectiveness and confirm the safety of transcervical intrauterine sonography-guided radiofrequency ablation with the VizAblate™ System in the treatment of symptomatic uterine fibroids. This was a multicenter, prospective, single-arm trial involving academic and community hospitals in the United Kingdom, the Netherlands, and Mexico. Women with qualifying uterine fibroids and heavy menstrual bleeding underwent intrauterine sonography-guided transcervical radiofrequency ablation (RFA) with the VizAblate System; anesthesia was individualized. Patients were required to have up to five fibroids from 1 to 5 cm in diameter. The primary trial endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months by an independent core laboratory. Secondary endpoints, evaluated at 6 and 12 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score, and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) questionnaire, along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assessments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, nonsurgical reintervention for abnormal uterine bleeding, anesthesia regimen, patient satisfaction, and pain during the recovery period. An addition...
Source: Gynecological Surgery - Category: OBGYN Source Type: research