Study of Volume Reduction of Uterine Fibroids After Embolization or Microwave Treatment

Uterine fibroids are benign tumors that occur most commonly in women of reproductive age. Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia, pressure symptoms, bowel symptoms or urinary urgency. In recent years, increasing attention has been paid to the study of minimally invasive methods for treatment. Microwave ablation of myomas and endometrium has been shown to have good effect and acceptability has been high. This study aims to compare the effectiveness, feasibility and acceptability of percutaneous or per vaginal microwave ablation and uterine artery embolization for the treatment of uterine myomas in a randomized single blind study. Primary outcome 1\. Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured as mean volume reduction of the 3 largest fibroids evaluated by magnetic Power calculation To be able to show a difference between the groups in myoma shrinkage at 6 months of 75% in microwave ablation and 50%\[11\] in the embolization group with a standard deviation of 25% with a alpha of 0.05 and a power of 80% we would need 16 women in each group and thus need to randomize 32 women. In order to compensate for loss to follow-up or drop out a total of 36 women will be randomized. Patients and investigators will not be blinded. The MRI will be performed and evaluated by a blinded radiologist. After having signed informed consent but before randomization patients will undergo MRI of the uterine fibroids. Patients with a single fibroid measuring more than mean diameter 8cm will be excluded from further participation in the study. All women included in the study after MRI examination will fill in a PBAC evaluation\[7\] during the menses preceding treatment. Women will fill a VAS for maximal pain during 1 month prior to treatment. Microwave ablation will be performed percutaneously or vaginally using a Covidien Emprint microwave ablation system. Embolization will be performed in conscious women with an epidural catheter for pain relief. At follow up visit 1, 3 months and 6 months post treatment acceptability will be assessed as overall satisfaction of treatment on a scale from 1-7 and if the woman would recommend the treatment to a friend. A new MRI scan will be performed 6 months post treatment (+/-15 days).

Sex

Female

Minimum age

30 Years

Maximum age

55 Years

Inclusion Criteria:

* Healthy women aged 30-55 with symptomatic fibromas (pressure, heaviness, bleeding, urgency)
* Premenopausal
* Fibromas with a maximum mean diameter of cm evaluated by trans vaginal or abdominal ultrasound
* Willing to comply with protocol

Exclusion Criteria:

* Current or future childwish
* Body Mass Index \>35
* Treatment with anticoagulant
* Bleeding disorder which leads to increased risk of bleeding
* Patients with single fibroid more than 6cm mean diameter according to MRI.
* Contraindication for UAE or general anesthesia

• BACKGROUNDKanaoka Y, Yoshida C, Fukuda T, Kajitani K, Ishiko O. Transcervical microwave myolysis for uterine myomas assisted by transvaginal ultrasonic guidance. J Obstet Gynaecol Res. 2009 Feb;35(1):145-51. doi: 10.1111/j.1447-0756.2008.00872.x. PMID 19215562
• BACKGROUNDZhang J, Feng L, Zhang B, Ren J, Li Z, Hu D, Jiang X. Ultrasound-guided percutaneous microwave ablation for symptomatic uterine fibroid treatment--a clinical study. Int J Hyperthermia. 2011;27(5):510-6. doi: 10.3109/02656736.2011.562872. PMID 21756048
• BACKGROUNDWang F, Zhang J, Han ZY, Cheng ZG, Zhou HY, Feng L, Hu DM. Imaging manifestation of conventional and contrast-enhanced ultrasonography in percutaneous microwave ablation for the treatment of uterine fibroids. Eur J Radiol. 2012 Nov;81(11):2947-52. doi: 10.1016/j.ejrad.2011.12.037. Epub 2012 Feb 16. PMID 22341698
• BACKGROUNDYang Y, Zhang J, Han ZY, Yu MA, Ma X, Zhou HY, Hao YL, Zhao L, Dong XJ, Ge HL. Ultrasound-guided percutaneous microwave ablation for submucosal uterine fibroids. J Minim Invasive Gynecol. 2014 May-Jun;21(3):436-41. doi: 10.1016/j.jmig.2013.11.012. Epub 2013 Dec 4. PMID 24316137
• BACKGROUNDZhao WP, Han ZY, Zhang J, Liang P. A retrospective comparison of microwave ablation and high intensity focused ultrasound for treating symptomatic uterine fibroids. Eur J Radiol. 2015 Mar;84(3):413-417. doi: 10.1016/j.ejrad.2014.11.041. Epub 2014 Dec 15. PMID 25572326
• BACKGROUNDKanaoka Y, Hirai K, Ishiko O. Microwave endometrial ablation for menorrhagia caused by large submucous myomas. J Obstet Gynaecol Res. 2005 Dec;31(6):565-70. doi: 10.1111/j.1447-0756.2005.00338.x. PMID 16343261
• BACKGROUNDReid PC, Coker A, Coltart R. Assessment of menstrual blood loss using a pictorial chart: a validation study. BJOG. 2000 Mar;107(3):320-2. doi: 10.1111/j.1471-0528.2000.tb13225.x.