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April 18th 2016

University of Maryland tests nonsurgical method of treating common fibroids

"I was bleeding and feeling drained, and I really couldn't take it anymore," she said. "I clicked."

Spellman, 45, who lives in Baltimore, was directed to information about a trial underway at nearly two dozen institutions, including the University of Maryland School of Medicine. The so-called Sonata trial is named for a device that uses heat to zap the common, noncancerous growths rather than a scalpel to cut them out, something she didn't want and said she couldn't afford.

Surgery is by far the most frequent treatment for fibroids, which afflict up to 80 percent of women of childbearing years, and doctors say most people are like Spellman and don't know there are other options available and in the works. Up to a quarter of sufferers have symptoms, and many live with the excessive bleeding, cramping and pressure because they want to avoid invasive procedures that come with risks and recoveries lasting weeks or months.

The trial continues to enroll women, and researchers hope to treat 150 patients with the method, which was approved in 2014 for use in Europe.

Removing fibroids with the device involves a trans-vaginal probe equipped with a radio-frequency device at the tip that is guided by ultrasound. Once a fibroid is located on the uterine wall, a small spear anchors the device. Doctors use a foot pedal to transmit radio waves through the device, generating heat. The energy vaporizes the fibroid.

Up to 10 fibroids of 5 centimeters or less can be treated in a sitting, though fewer is better, said Dr. Vadim Morozov, an assistant professor in Maryland's department of obstetrics, gynecology and reproductive sciences, and the physician in charge of the study at Maryland.

Each fibroid takes only minutes to dissolve as doctors watch the vapors form shadows on a laptop screen, and patients head home soon afterward, Morozov said.

"This gets patients back on their feet and in normal activity quickly," he said. "Who wants to spend three months recovering?"

Morozov said his department was approached for the trial by Gynesonics Inc., a Redwood City, Calif.-based firm focused on developing minimally invasive technology for treating fibroids that has raised $46 million to develop and conduct trials as it seeks approval of the system.

He was interested in a new nonsurgical option for his patients, though he doesn't believe it will completely replace surgery. Some fibroids are too big or numerous, or in a position where the machine can't attach to them.

There is growing consensus, however, that there are too many hysterectomies, the surgical removal of the uterus, commonly performed to treat fibroids. While such surgeries are trending down, there are still more than 500,000 performed each year, according to the American Congress of Gynecologists.

Doctors are telling patients about a growing variety of options, including:

  • Myomectomies, or surgical removal of fibroids, which leave the uterus intact.
  • Endometrial ablation, a procedure that destroys the lining of the uterus and controls bleeding.
  • Uterine fibroid embolization, another less-invasive procedure that blocks blood flow to fibroids.
  • Another non-surgical technique that uses heat to treat fibroids, like the Sonata method, but it's performed inside an MRI scanner and only can treat a small amount of fibroid tissue.

The least-invasive form of treatment controls bleeding with hormone therapy, such as birth control pills or intrauterine devices, known as IUDs.

"There are pros and cons for each method, and we don't have a perfect method of treatment at this time," said Dr. Bala Bhagavath, an associate professor of obstetrics and gynecology at the University of Rochester Medical Center's division of reproductive endocrinology and infertility.

He's not involved in the trial at Maryland but is hopeful that the outcome will be another nonsurgical treatment that removes fibroids and doesn't have significant side effects. For now, he spends a lot of time counseling patients on which procedures offer them the most specific relief with the least amount of intervention.

Some procedures can only treat a small amount of fibroid tissue, he said. Hormones help many women who only have bleeding but won't ease pressure or bloating. Hysterectomies mean fibroids can't come back, but the surgery requires a long recovery period. Myomectomy is recommended when women still wish to become pregnant.

The Sonata device isn't being tested on women who want more children, though Morozov said it may one day be used for those women.

The idea of the new method is "very attractive," said Dr. Scott C. Goodwin, professor and chairman in the department of radiological sciences at the University of California at Irvine. But as with all trials, he wants to see how women fare longer-term. He also wants to see studies directly comparing it with other methods.

Eventually, Goodwin believes the best treatment will be medication that targets the gene or genes linked to fibroids rather than a procedure. Until then, he will counsel women so they understand there are less-invasive choices than hysterectomy.

"One alternative is 'watchful waiting,' where we do no treatment," he said. "I saw a woman recently who had no symptoms — no pain, bleeding, bloating or frequent urination — yet she had been told she needed a hysterectomy just because an image showed she had fibroids. She was happy to hear I didn't see why she needed it."

Spellman, who was Morozov's first Sonata trial patient, was glad to find an alternative to surgery. She called Maryland's School of Medicine last year, had the procedure to vaporize three fibroids in December and was back to work as a floor supervisor at Horseshoe Casino Baltimore two days later.

"The procedure was easy," said Spellman, who said she felt no pain or burning. "I'm getting back to myself now."

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