Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy

Inclusion Criteria

• •Women with symptomatic and medically untreatable uterine fibroids who score at least 40 points on the Symptom Severity Score (SSS) of the Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS- QoL )
• •Safe access for the MRgFUS possible (anatomical position of the fibroids): Pelvic magnetic resonance imaging to document the number, location and size of fibroids and to exclude malignancy and other pelvic pathologies; necessary to determine whether MRgFUS can be performed technically (presence of a stable ultrasound window and exclusion of scars in the access path)
• •≤ 5 fibroids requiring treatment
• •Fibroids with a diameter ≤ 10 cm
• •Total myoma volume ≤ 400 ml
• •Patient is suitable for treatment with MRgFUS-TUF as well as for myomectomy
• •Desire for least invasive treatment
• •Indication for hysteroscopy and fractionated abrasion depending on the bleeding pattern and endometrial thickness and structure have been critically tested in advance.
• •inconspicuous cytological smear of the cervix uteri not older than 12 months
• •No previous uterine surgery / intervention
• •Female patients aged\> 18 years. Patients of reproductive age must adhere to appropriate contraception until 6 months after the procedure. (Methods of contraception that meet the criteria of highly effective contraception in the sense of the Note for guidance on non- clinical safety studies for the conduct of human clinical trials for meet pharmaceuticals \[CPMP / ICH / 286/95 mod \]). Patients of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
• •Karnofsky index ≥ 70
• •Given medical operability
• •Written consent of the patient