Study on Treatment of Fibroids

by Jennifer Redmond, Editor-in-Chief, Mar. 12, 2010

As many as one in five women of childbearing age have uterine fibroids. These non-cancerous tumors -- sometimes referred to as myomas – are found inside the uterus wall, inside the uterine cavity or outside the uterine cavity and can hinder a woman’s ability to get pregnant (not to mention the discomfort they cause!) A study is currently underway to measure the safety and effectiveness of a technique to treat them, radiofrequency ablation (RFA) using the Halt System.

The Halt System is a Radiofrequency Generator with accessories that are designed to deliver radiofrequency energy through a hand-held disposable probe. Treatment consists of laparoscopic surgery in which intra-abdominal ultrasound guides RFA, providing a current which creates heat, builds up friction between cells, and ultimately shrinks fibroids.

Dr. Charles Miller, a reproductive endocrinologist at The Advanced IVF Institute, in Naperville, IL, specializes in minimally invasive gynecologic surgery. Miller explains that RFA can be done a couple of ways – via the Halt Procedure, which is FDA approved, or with an ultrasound through the endometrial cavity – which is not yet FDA approved. Both work on ultrasound guidance.

“The trouble with RFA,” Miller says, “is it will not remove the fibroid, but cause it to shrink.” The procedure is not well documented in terms of pregnancy outcomes, he adds.

In addition, Miller points out other concerns related to RFA:

• Unless you remove the fibroid, it can disrupt blood flow to, and growth of, the endometrium.
• We don’t know about uterine integrity or how the endometrium will perform following RFA; Will there will be higher miscarriage rates or higher incident of premature labor?
• Would the patient be at risk of uterine rupture?
• To what degree will treatment protect surrounding tissue in the endometrium?

According to Miller, for women who want to get pregnant one day, the “best and only option [to treat fibroids] is myomectomy.”