Uterine Artery Embolization Is a Safe and Effective Alternative to Hysterectomy
Alicia Armeli

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Ten-year results of the Emmy Trial (EMbolization versus hysterectoMY) confirm that uterine artery embolization (UAE) is a safe and effective alternative to hysterectomy. Given these findings, researchers concluded that the majority, about two-thirds, of women undergoing UAE for treatment of symptomatic uterine fibroids can avoid having a hysterectomy all together.

For two decades, UAE has been described as a minimally invasive alternative to hysterectomy—a procedure that surgically removes the uterus. In contrast, UAE involves only a tiny nick in the groin or wrist to access the arteries that lead to the uterine arteries. A doctor called an interventional radiologist then inserts a thin catheter and releases small particles called embolics to block blood flow to the fibroids, causing them to shrink and symptoms to subside.

In 2005, the EMMY Trial sought to evaluate UAE in comparison to hysterectomy for the treatment of fibroids.1 Between 2002 and 2004, 177 women who suffered from symptomatic fibroids and who were eligible for hysterectomy were recruited from 28 Dutch hospitals.

Overall, 81 women were randomly assigned to UAE and 75 to hysterectomy. The remaining twenty-one patients withdrew from the trial. Results showed that UAE had comparably low major complication rates that were similar to hysterectomy. Although linked with more minor complications, such as bruising at the puncture site or nausea, UAE had a significantly shorter hospital stay. Quality of life improved dramatically in both groups.

10-years later, Dr. Annefleur M. de Bruijn, MD, and a team of researchers at the VU University Medical Center in Amsterdam, followed up with each woman participating in the trial.2 Through mailed questionnaires, they analyzed health-related quality of life, patient satisfaction, and treatment reintervention rates. Published earlier this year in the American Journal of Obstetrics and Gynecology, this study is the longest follow-up so far from a randomized comparison between UAE and hysterectomy.

Of the original 156 women, 131 responded and their feedback was compared to the original treatment outcomes. Based on the responses received, 35% (28 of 81) of the women who underwent UAE ended up having a hysterectomy (4 due to persisting symptoms, 1 due to a prolapsed uterus). Of these women, about 30% (24 out of 77) had what was considered a successful UAE procedure. These results indicate that about two-thirds of women undergoing UAE can avoid hysterectomy.

The 10-year outcomes also showed health-related quality of life scores to remain stable in both groups without any major differences. In each group, the majority of women (78% UAE versus 87% hysterectomy) said they were very satisfied with the treatment they received.

Given these results, the authors concluded UAE to be “a well-documented and less invasive alternative to hysterectomy” and that hysterectomy could be avoided in the majority of women treated with UAE

Although noncancerous, uterine fibroids can cause symptoms like heavy periods, pelvic pain, and incontinence. To treat symptoms, hysterectomy is currently the most common—and one of the most unnecessary—gynecological surgeries in the nation. An estimated 600,000 hysterectomies are performed annually, the majority—nearly 41%—to treat fibroids.3,4

Given the mounting clinical evidence surfacing in support of UAE for the treatment of symptomatic fibroids, Dr. de Bruijn and her team urged clinicians to counsel women with fibroids who are candidates for hysterectomy about the option of UAE.

 

ABOUT THE AUTHOR   Alicia Armeli is a Health Freelance Writer, Editor, 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. She is a paid consultant of Merit.

 

REFERENCES

  1. Hehenkamp, W., Volkers, N., Donderwinkel, P., de Blok, S., Birnie, E., Ankum, W., & Reekers, J. (2005). Uterine artery embolization versus hysterectomy in the treatment of symptomatic uterine fibroids (EMMY trial): Peri- and postprocedural results from a randomized controlled trial. American Journal of Obstetrics And Gynecology, 193(5): 1618-1629. http://dx.doi.org/10.1016/j.ajog.2005.05.017
  2. de Bruijn, A., Ankum, W., Reekers, J., Birnie, E., van der Kooij, S., Volkers, N., & Hehenkamp, W. (2016). Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 10-year outcomes from the randomized EMMY trial. American Journal of Obstetrics And Gynecology. doi: 10.1016/j.ajog.2016.06.051
  3. Centers for Disease Control and Prevention. (2016). Fact sheet: Hysterectomy in the United States, 2000–2004. Retrieved July 13, 2016, from http://www.cdc.gov/reproductivehealth/data_stats/
  4. The American Congress of Obstetricians and Gynecologists. (2011). Choosing the Route of Hysterectomy for Benign Disease. Retrieved July 13, 2016, from http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Choosing-the-Route-of-Hysterectomy-for-Benign-Disease

 

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

 

Women with High Testosterone Levels May Have an Increased Risk for Fibroids
Alicia Armeli

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Uterine fibroids are believed to be a hormone-driven condition. These noncancerous tumors are most common among perimenopausal women in their 40s and early 50s when estrogen levels are seen to surge.1,2 But new research is showing that estrogen isn’t the only culprit. A study published earlier this year in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism showed that women in midlife with both high levels of estrogen and testosterone are at a greater risk of developing fibroids.3

The 13-year long study looked at hormone levels of women participating in the Study of Women’s Health Across the Nation (SWAN).3 Led by Jason Y.Y. Wong, ScD, of Stanford University School of Medicine in Stanford, Calif., a team of researchers investigated the potential relationship of circulating estrogen and testosterone levels with the risk of developing fibroids.

Of the initial 3,240 women participating in the study, 43.6% completed nearly annual follow-up visits, which included testing for levels of estrogen and testosterone in the blood and asking whether they had been diagnosed with or treated with fibroids.

Results showed that 512 women reported a single occurrence of fibroids and 478 women had recurrent fibroids. In comparison to women with low levels of testosterone, the authors of the study found that women who had high testosterone levels were 1.33 times more likely to have a single incidence of fibroids. This risk was even greater in women with both high testosterone and estrogen levels. However, even though these same women were at a heightened risk for a single incidence of fibroids, they were less likely to experience a recurrence.

“Our research suggests women undergoing the menopausal transition who have higher testosterone levels have an increased risk of developing fibroids, particularly if they also have higher estrogen levels,” Dr. Wong said in an Endocrine Society press release. “This study is the first longitudinal investigation of the relationship between androgen and estrogen levels and the development of uterine fibroids.”4

Fibroids affect up to 80 percent of women by age 50, with African American women being at a higher risk.1 Not always symptomatic, fibroids can be the cause of heavy menstrual bleeding, pelvic pressure, painful intercourse, and incontinence and can take a major toll on a woman’s quality of life. Estrogen has been associated with the development of fibroids, while testosterone’s potential role has been unknown. Although testosterone is commonly seen as a male hormone, women also naturally produce small amounts.

“Our findings are particularly interesting because testosterone was previously unrecognized as a factor in the development of uterine fibroids,” added co-author Jennifer S. Lee, MD, PhD, of Stanford University School of Medicine and Veterans Affairs Palo Alto Health Care System in Palo Alto, CA. “The research opens up new lines of inquiry regarding how fibroids develop and how they are treated.”

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.

 

REFERENCES

  1. US Department of Health and Human Services, Office on Women’s Health. (2015). Uterine fibroids fact sheet. Retrieved November 11, 2016, from https://www.womenshealth.gov/publications/our-publications/fact-sheet/uterine-fibroids.html
  2. The Centre for Menstrual Cycle and Ovulation Research. (2014). Perimenopause is a time of “Endogenous Ovarian Hyperstimulation.” Retrieved November 11, 2015, from http://www.cemcor.ubc.ca/resources/perimenopause-time-“endogenous-ovarian-hyperstimulation
  3. Wong, J., Gold, E., Johnson, W., & Lee, J. (2016). Circulating sex hormones and risk of uterine fibroids: Study of Women’s Health Across the Nation (SWAN). The Journal of Clinical Endocrinology & Metabolism, 101(1): 123-130. doi: 10.1210/jc.2015-2935. https://www.ncbi.nlm.nih.gov/pubmed/26670127
  4. Endocrine Society. (2015). Elevated Testosterone Levels May Raise Risk of Uterine Fibroids. Retrieved November 12, 2016, from https://www.endocrine.org/news-room/press-release-archives/2015/elevated-testosterone-levels-may-raise-risk-of-uterine-fibroids

 

 

Why Women With Fibroids Are Putting Off Treatment
Alicia Armeli

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An estimated four out of five women will have uterine fibroids in their lifetime.1 Despite their ubiquity, these noncancerous tumors are very different from one woman to the next. Fibroids can grow in different sizes, different locations in the uterus, and may or may not cause symptoms. While some women aren’t even aware they have fibroids, others can experience unavoidable symptoms such as heavy periods, anemia, pelvic pain and pressure, incontinence, and even infertility.

Women with symptomatic fibroids have reported their condition has interfered with daily activities, relationships, and even work. And yet, on average, a woman with symptomatic fibroids will wait almost 4 years before seeking medical treatment.2

Why the wait?

“I never had period pain when I was younger,” Kellie, a Philanthropy Manager who resides in Atlanta, Ga., explains. “For a long time, I rationalized that maybe everybody gets cramps at some point. I guess this is just my turn. That was what I told myself as it got progressively worse.” This reaction to fibroid symptoms isn’t unusual. Like Kellie, many women attribute worsening periods to a normal progression in life.

To investigate why women seek treatment or—in some cases—wait, researchers at Northwestern University Feinberg School of Medicine and the University of Illinois at Chicago College of Medicine in Chicago, Ill., interviewed 60 women of ethnically diverse backgrounds who either have symptomatic fibroids or who had been recently treated for their condition.3

“Despite their [uterine fibroids] high prevalence and associated morbidity, there are little qualitative data characterizing what drives women’s treatment-seeking behavior for their fibroids,” writes Erica E. Marsh, MD, MSCI, Adjunct Associate Professor of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility at Northwestern University Feinberg School of Medicine and co-author of the study.3

Results published earlier this year in the Journal of Women’s Health reported many women delayed diagnosis even though they were having severe symptoms.3 Five major themes surfaced. Many women believed their symptoms were “normal.” Women also reported knowing little about normal menstruation and fibroids. Other reasons included not believing they were at risk for fibroids, avoiding the problem as a way to cope with their condition, and/or dissociating themselves from their fibroids.

“Many women with symptomatic fibroids live with this condition chronically without seeking care,” Dr. Marsh and her team reports. “It appears that for some, limited knowledge regarding fibroids and normal menstruation may lead to a distorted view of what is normal with regard to uterine bleeding, resulting in limited treatment seeking behavior. Others know their symptoms are abnormal but simply avoid the problem.”3

A 2011-2012 Harris Interactive online survey of more than 800 women with fibroids showed that over half were worried they would need a hysterectomy.2 This concern may also keep a woman from seeking treatment.

“My turning point was when I bled for one month straight,” recalls Carmen, a Registered Nurse in Atlanta, Ga., who wasn’t involved in the study. And yet, Carmen refused to get medical treatment for her fibroids. “The help I received from medical professionals was—operate. Hysterectomy. That was it.” Not wanting a hysterectomy, Carmen remembers waiting and educating herself by reading countless articles about treatment options. “My main objective was, I did not want to get rid of my uterus.”

Misinformation, whether its concerning normal periods or treatment options, is a problem among women with fibroids. “There is a need for patient-centered and community-based education to improve women’s knowledge of fibroids and symptoms and to promote treatment options,” Dr. Marsh reports.3

But when it comes to your period, what’s considered normal?

Normal can differ between women, but according to the US Department of Health and Human Services, the average menstrual cycle is 28 days long but can range anywhere between 21 to 35 days in adults and 21 to 45 days in young teens.4 Period length also varies with most periods lasting from 3 to 5 days, but anywhere from 2 to 7 days is considered normal.4
Although bleeding and cramping are normal, women who experience severe pain, heavy and/or irregular bleeding—for example, a period lasting longer than 7 days, using more than 1 pad or tampon every 1 to 2 hours; and bleeding between periods or after sex—should question what they’re experiencing, and above all, visit their doctor.4

By starting the conversation—with doctors and amongst themselves—women can get the answers and support they need and not feel so alone. “There are a lot of women out there who are struggling with this and they don’t talk about it. They just suffer in silence,” Carmen says—who later found uterine fibroid embolization, a less-invasive treatment option that worked for her and allowed her to keep her uterus. “I hope that by doing this, I let other women know–there is an alternative—that you can have your life back.”

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.

 

REFERENCES

  1. Stewart, E., Laughlin-Tommaso, S. (2016). UpToDate—Patient education: Uterine fibroids (Beyond the Basics). Retrieved October 31, 2016, from http://www.uptodate.com/contents/uterine-fibroids-beyond-the-basics
  2. Stewart, E., Nicholson, W., Bradley, L., & Borah, B. (2013). The burden of uterine fibroids for African-American women: results of a national survey. Journal of Women’s Health, 22(10): 807-816. doi:  10.1089/jwh.2013.4334. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3787340/
  3. Ghant, M., Sengoba, K., Vogelzang, R., Lawson, A., & Marsh, E. (2016). An altered perception of normal: understanding causes for treatment delay in women with symptomatic uterine fibroids. Journal of Women’s Health, 25(8): 846-852. doi: 10.1089/jwh.2015.5531. https://www.ncbi.nlm.nih.gov/pubmed/27195902
  4. Office on Women’s Health, US Department of Health and Human Services. (2014). Menstruation and the menstrual cycle fact sheet. Retrieved November 1, 2016, from https://www.womenshealth.gov/publications/our-publications/fact-sheet/menstruation.html