The TRUST Study: Helping Women with Fibroids Look Beyond Hysterectomy
Alicia Armeli

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Hysterectomy is the second most frequently performed surgical procedure among American women of reproductive age.1 Roughly 600,000 hysterectomies are performed each year in the US alone—with the majority of these surgeries done to treat uterine fibroids.1,2

But hysterectomy—or the surgical removal of the uterus—has its drawbacks. Due to the increased risk of complications and longer recovery times associated with this surgery, researchers have teamed up to launch the TRUST Study—a clinical trial investigating the short and long-term effects of three less invasive uterine-sparing fibroid treatments.3 With the goal of building awareness around alternative procedures, the TRUST Study offers women hope and fibroid relief—without the need for hysterectomy.

“Hysterectomies have been and still are the leading technique that’s used for treating women that have excessive uterine bleeding and pain from fibroids,” says Dr. Donald I. Galen, Minimally Invasive Gynecological Surgeon and Female Infertility Specialist in San Ramon, Calif., Consulting Medical Officer for Halt Medical Inc., and Principal Investigator of the TRUST Study. “It’s a technique that was certainly appropriate a hundred years ago, but in the last 20 years or so, and especially in the last three or four years, there has been an increasing desire for less invasive uterine-sparing techniques that are actually equally or more effective and much easier on patients.”

Uterine fibroids are noncancerous tumors that grow in the wall of the uterus and are an exceedingly common disease that affects up to 80% of women by age 50.4 Although a widespread condition, fibroids don’t always cause a problem. But among women who suffer from symptoms—painful periods, pelvic pressure, heavy abnormal bleeding, and infertility can become the norm. Symptoms like these can greatly take a toll on personal relationships and quality of life and are what cause 30% of women with fibroids to seek out medical intervention.5

Of the interventions available to women, hysterectomy is the procedure that’s most widely offered, despite its link to complications. Although curative of fibroids, hysterectomy has been associated with a longer recovery time that can last up to six weeks. Long-term complications include increased risks of heart attack and stroke and can be the cause of urinary and sexual dysfunction.6,7

In an effort to help women with symptomatic fibroids look beyond hysterectomy, Dr. Galen and fellow researchers initiated the TRUST Study earlier this year.3 Standing for Treatment Results of Uterine Sparing Technologies, the TRUST Study has been approved by the Food and Drug Administration (FDA), as well as the Independent Review Board (IRB). Consisting of 300 women spanning several medical centers across the US and Canada, the 2-year randomized clinical trial compares three uterine-sparing treatments—global fibroid ablation (GFA), uterine fibroid embolization (UFE), and myomectomy. Funded by Halt Medical Inc.—the medical device company that developed GFA—the TRUST Study will follow participating women for 5 years after treatment, tracking their outcomes. “In the TRUST Study we’re comparing safety, costs, any adverse events, recovery, and reintervention rates associated with the three different treatments,” Dr. Galen explains.

The first of the three therapies investigated, GFA, also known as laparoscopic radiofrequency ablation, treats fibroids through two small incisions made in the abdomen. An ultrasound probe is inserted to help gynecologists locate the fibroids with high accuracy. Once found, small heat-generating electrodes are positioned in each fibroid, destroying fibroid tissue.

The next procedure, UFE, begins with a tiny nick in the groin or wrist. Under real-time magnetic resonance imaging (MRI), a doctor called an interventional radiologist inserts a small tube called a catheter through this incision and into the arteries that lead to the uterine arteries. Tiny particles are then released from the catheter into the uterine arteries in order to block blood flowing to the fibroids. Without a blood supply, fibroid tissue shrinks and dies.

The final treatment option in the study—myomectomy—is the selective surgical removal of fibroids from the uterus. This surgery is most commonly performed through a large incision in the abdomen but can also be done laparoscopically—a technique that inserts slender scopes and surgical instruments into the abdomen by way of small incisions.

“These procedures all have different pluses or minuses, but the overall effect of this study so far has been good and patients are giving positive feedback,” Dr. Galen continues. “For years, gynecology, like many other medical specialties, didn’t take the full patient into consideration. They just looked at the most expedient ways to treat. But nowadays we’ve advanced so much in terms of medicine that patient care has really improved.”

Much of this shift has been in response to patient awareness. Women have become self-advocates, seeking out less invasive treatment alternatives to hysterectomy. With resources readily available on the Internet and through social media, women are becoming aware of uterine-sparing therapies that can successfully treat their fibroids with fewer complications and shorter recovery times. And doctors across the continent are beginning to meet this demand. Through medical associations and published literature, more and more doctors are now learning about these techniques and offering all treatment options to their patients, which is something Dr. Galen believes is pivotal to patient care.

“We anticipate this positive reaction to minimally invasive uterine-sparing treatment options to continue and increase in the future,” Dr. Galen encourages. “Because of these newer and safer technologies, we’re making a big difference and improving the lives of women.”

ABOUT THE AUTHOR   Alicia Armeli is a Health Freelance Writer, Registered Dietitian Nutritionist, and Certified Holistic Life Coach. She has master’s degrees in English Education and Nutrition. Through her writing, she empowers readers to live optimally by building awareness surrounding issues that impact health and wellbeing. In addition to writing, she enjoys singing, traveling abroad and volunteering in her community.

ABOUT THE DOCTOR Donald I. Galen, MD, FACOG, is a minimally invasive gynecological surgeon and female infertility specialist in San Ramon, Calif. He’s certified by the American Board of Obstetrics & Gynecology and by the Accreditation Council for Gynecologic Endoscopy. He holds several professional memberships, including the Society of Reproductive Surgeons. Dr. Galen has served as Principal Investigator in many medical device and pharmaceutical clinical trials, thereby developing concepts and technology that offer women less invasive options. With the goal of teaching patients and physicians about these treatments, Dr. Galen is an active leader of hands-on physician training, as well as a public speaker and author.

REFERENCES

  1. Centers for Disease Control and Prevention. (2016). Data and Statistics: Hysterectomy. Retrieved December 1, 2016, from http://www.cdc.gov/reproductivehealth/data_stats/
  2. The American Congress of Obstetricians and Gynecologists (ACOG). (2015). Hysterectomy. Retrieved December 1, 2016, from http://www.acog.org/Patients/FAQs/Hysterectomy
  3. ClinicalTrials.gov. (2016). Post Market TRUST Study (TRUST). Retrieved December 1, 2016, from https://clinicaltrials.gov/ct2/show/NCT01563783
  4. Office on Women’s Health: US Department of Health and Human Services. (2015). Uterine Fibroid Fact Sheet. Retrieved December 2, 2016, from https://www.womenshealth.gov/publications/our-publications/fact-sheet/uterine-fibroids.html
  5. National Women’s Health Network. (2015). Uterine Fibroids. Retrieved December 1, 2016, from https://www.nwhn.org/uterine-fibroids/
  6. Ingelsson, E., Lundholm, C. Johansson, A., & Altman, D. (2011). Hysterectomy and risk of cardiovascular disease: a population-based cohort study. European Heart Journal, 32(6): 745-750. doi: 10.1093/eurheartj/ehq477. https://www.ncbi.nlm.nih.gov/pubmed/21186237
  7. Clarke-Pearson. D., & Gellar, E. (2013). Complications of hysterectomy, Obstetrics and Gynecology, 121(3): 654-673. doi: 10.1097/AOG.0b013e3182841594. https://www.ncbi.nlm.nih.gov/pubmed/23635631