While many uterine fibroids are asymptomatic, some can cause pain during sexual intercourse and menstruation, as well as heavy bleeding and urinary frequency and urgency. The clinical study is named ULTRA ― Uterine Leiomyoma (fibroid) Treatment with Radiofrequency Ablation. Its aim is to evaluate how women’s fibroid symptoms change over three years following minimally invasive fibroid ablation, using a new United States Food and Drug Administration-approved device called the Acessa System.
The device allows clinicians to insert a small electrode array into the fibroid, which then heats, necrotizes and ultimately shrinks the fibroid. The investigators’ main goal will be to determine the long-term efficacy of the use of Acessa by evaluating the rate of re-treatment for symptomatic fibroids after the procedure.
If long-term relief is achieved, the procedure would be an important alternative for women with fibroids who desire uterine conservation to avoid hysterectomy and the risk of major surgery. Ultimately, this treatment may be appropriate for women who wish to preserve their fertility. Researchers also are seeking to determine such factors as procedure duration, complications, blood loss, post-operative pain and the time from surgery to return to normal activities in patients treated with radiofrequency fibroid ablation.
The study is being conducted through the University of California Fibriod Network (UCFN) and led at UC Davis by Professor Elaine Waetjen and Assistant Clinical Professor Bahareh Nejad, both of the Department of Obstetrics and Gynecology.
“Uterine fibroids are a common condition affecting thousands of women in the United States that can cause debilitating bleeding and pain as well as affect a woman’s fertility,” Waetjen said. “Despite the high prevalence of fibroids, treatment options are limited.
“We are excited to participate in this University of California-wide research initiative which, we hope, will offer important and timely information for physicians and their patients on the effectiveness of novel fibroid treatment technologies as they emerge in medical practice.”
The researchers will follow the study participants for three years after undergoing the procedure. The participants will be asked to complete questionnaires every three months for the first year, then every six months for the second and third years of participation.
Women interested in participating in the study must be at least 21 years old, have fibroids, and be able to participate in laparoscopic surgery. For further information about the ULTRA Study at UC Davis, please contact study coordinator Sarah Steimer, 916-734-6846, [email protected]
Improving the quality of information about the effectiveness of fibroid treatments has been deemed a research priority in women’s health by the National Institutes of Health (NIH). The UCFN was developed under a University of California Office of the President (UCOP) Research Opportunities grant and is a collaboration of researchers at the departments of obstetrics and gynecology at the five University of California medical centers at San Francisco, Los Angeles, Irvine San Diego and Davis.
The Acessa System is manufactured in California by Halt Medical, Inc. ULTRA is an investigator-initiated study, the first study of the UCFN, and is funded by a grant from Halt Medical, Inc. and UCOP. The UCFN is seeking NIH funding for future studies related to fibroid treatments.