NEWS! CAUSES & EFFECTS IN WOMENS’ HEALTH
Diagnosing Endometriosis Without Undergoing Surgery Could be on the Horizon
At this point in time, the only way to actually confirm a diagnosis of Endometriosis is through a surgical procedure. Further complicating the issue, is the fact that the symptoms of Endometriosis are common to many other conditions, each of which would ideally be ruled out prior to the surgical procedure required to confirm the diagnosis. The result is a long and frustrating process where the patient continues to experience daily challenges stemming from symptoms like pain and excessive bleeding.
A faster and less invasive means for confirming an Endometriosis diagnosis however could be on the horizon. Researchers at the Feinstein Institute for Medical Research have found that specific genetic mechanisms, cellular changes and characteristics contained in menstrual blood may provide the basis for a non-surgical solution in confirming the existence of Endometriosis. The team initiated a study program called Research Out-Smarts Endometriosis (ROSE). The program collected menstrual blood samples from volunteers, both those with confirmed diagnoses of Endometriosis as well as from healthy individuals without the condition, for study and made them available for other researchers via a stored biobank.
Professor Christine N. Metz, PhD, one of the leaders of the research effort, cited the potential benefits of the findings. “In this study, we found that the stem cells in the menstrual blood of women with endometriosis are very different from those of healthy women and we are learning from these differences to develop a novel non-invasive diagnostic.” She went on to explain, “instead of having to undergo surgery to accurately diagnose endometriosis, these findings will enable us to develop a rapid test for endometriosis based on menstrual blood, which can be easily collected.”
The benefits of a reliable, non-surgical diagnostic approach are multifaceted. Drastically compressing the timeline required to confirm the diagnosis means patients can receive the appropriate treatment sooner. Consequently, the period of time patients must endure the symptoms of the disease while ruling out other potential causes would also be reduced. A non-surgical solution is also likely to be far less expensive in terms of healthcare costs. Finally, the inherent risk that accompanies any surgical procedure would be completely avoided, at least in the diagnostic stage of treatment.
What is Laparoscopic Surgery (AKA: Keyhole Surgery/Bandaid Surgery)
Before the development of laparoscopic surgery, the doctor would find it necessary to make much larger incisions in order to have the space to see and work. In the case of laparoscopic surgery, only a series of small cuts roughly one-half inch long or so are needed, through which various specialized sugical tools can be inserted to perform that procedure. This is commonly described as “minimally invasive” surgery. As one might imagine, this is far less invasive than conventional surgery, and comes with a dramatic reduction in recovery time for the patient. Scarring is also greatly reduced due to the small incision size, providing a cosmetic benefit as well.
While the procedure is being performed the patient is under general anesthesia and therefore feels no pain. After the initial small incision is made in the abdomen, a tube is inserted through which carbon dioxide is passed in order to inflate, or lift, the abdomeninal wall away from the organs below. This provides spacing to allow the surgeon to get the best view of the work area when the laparoscope’s video camera is inserted. At this stage the surgeon will determine the appropriate locations for additional small incisions through which surgical instruments will be inserted to carry out the procedure. At the conclusion of the operation, the carbon dioxide gas will be released and the incisions closed.
Robotic Laparoscopy
In certain cases, the surgeon may choose to employ robotic technology after making the initial laparoscopic incision and evaluating the video. Robotic Laparoscopy uses mechanical arms controlled by the surgeon via a computer. The system provides magnified high-resolution imaging of the work area inside the body enabling an increased level of surgical precision. This approach is often used in gynecological and urological procedures such as fibroid surgeries, endometriosis surgeries and prostate removal. As with non-robotic laparoscopic surgery described above, the greater the precision, the less prone the patient will be to excess bleeding and post-operative pain—and the shorter the recovery period is likely to be.
Endometriosis Surgery: A Few Things to Consider
Expectations:
• First and foremost, it must be recognized by the patient that every case is unique. Often there are unforeseen issues that become evident only during the surgical procedure. Surgeons will generally adopt one of two approaches. The first is a one-step approach where the surgeon explains all of the potential eventualities to the patient in advance with the idea that the procedure will move along a flexible path depending on findings that arise during surgery. The second is a two-step approach where the initial surgery works on a predefined, and generally more limited, scope where specific issues and/or outliers encountered during the procedure are left to be addressed via a second operation at a later date.
Future Fertility
• Endometriosis can adversely affect fertility in women of reproductive age. And while surgery can mitigate the condition’s symptoms, the procedure itself can also impact future fertility. In fact, depending on severity and location of the condition, and the skill and experience of the surgeon performing the laparoscopic procedure, surgical removal of the Endometriosis may make all the difference in whether or not fertility can be preserved. When removing ovarian Endometriosis, for example, extreme care must be taken by the surgeon to preserve as much of the ovarian tissue as possible.
Potential Recurrence
• It has been shown that there is a risk of recurrence after Endometriosis surgery, particularly in areas adjacent to locations of prior lesion removal (as opposed to new or distant areas) most likely due to remnants of the foci of Endometriosis that may not have been visible at the time of the initial surgery.
Hormone Therapy
• Some studies have shown that a combined approach using laparoscopic surgery and hormone therapy may offer better long-term outcomes than adopting either soltuion alone in reducing the incidence of recurrence. Again, every case is unique and only the surgeon can help in determining the best course of action for any individual case.
Again, while the list above is far from comprehensive, it does highlight several important issues patients may want to raise with their doctors when considering surgery for Endometriosis symptom relief.
Uterine Fibroids Found to be More Prevalent in African American Women
Furthermore, research indicates that African American women tend to develop benign uterine fibroids at younger ages, and they are likely to grow larger and cause more severe symptoms than is the case for Caucasian women.
In an effort to gain greater understanding of the mechanism(s) which may contribute to this discrepancy, researchers have examined a number of potential relationships:
Keloid Scarring
One such possible connection may lie in the similarity between UF tissue and the tissue in Keloid (raised) scarring, a common genetic trait among African Americans. Keloid scarring involves the formation of excess fibrous connective tissue during the repair process, and may be a contributing factor to the increased incidence of UF in this ethnic group.
Estrogen Dominance Syndrome (EDS)
Higher levels of estrogen have been linked to fibroid growth, and some studies suggest that African American women tend to have higher levels of this hormone than women of other races. Just as influential, may be the lower levels of progesterone in African American women, the counter hormone to estrogen. In combination, (high levels of estrogen and lower levels of progesterone), the resulting condition called Estrogen Dominance Syndrome may cause extremely heavy periods, particularly in younger African American women.
While there are many other potential factors which may contribute to the differences in uterine fibroid growth between ethnic groups, these are two that have gained recent attention. And, while researchers continue to investigate the possible cause(s) for these differences, one thing remains clear—every case is unique in nature. Therefore every case is also unique with regard to potential treatment options, and only a direct consultation with a medical professional can help plot the best course of action for any individual patient.
Recent Studies Uncover Links to Increased Incidence and Severity of Endometriosis
Endometriosis and Non-Processed Red Meat
According to a study published in the American Journal of Obstetrics and Gynecology, women who consume more non-processed red meat may have an increased tendency to develop Endometriosis as opposed to those who consume less. While only two studies have so far investigated the link between meat consumption and Endometriosis, and results are far from indisputable, it is clear that diet can affect hormone levels. By increasing levels of estrogen and prostaglandin, the consumption of more red meat may play a role in exacerbating the inflammatory characteristics of the condition.
This latest study found the strongest link between Endometriosis and the consumption of non-processed red meats like beef, pork, hamburger, lamb and liver. Statistical analysis found no link between the condition and the consumption of eggs, fish, shellfish or poultry.
Endometriosis and Obesity
Another recent Australian study published in the Journal of Endometriosis and Pelvic Pain Disorders found that there may be a link between obesity and the severity of Endometriosis symptoms. While earlier studies suggested that women suffering from the condition were more likely to be underweight than overweight, this study focused on the severity and frequency of symptoms rather than simply the existence of the ailment.
The Australian study found that severity scores for the condition were significantly higher in obese women as compared to pre-obese or women with a normal body mass index (BMI). However, similar to the findings in earlier studies, this new study also found a higher incidence of the presence of the disease in underweight women, even though the symptoms tended to be less severe.
The role of BMI in determining the incidence, or severity, of Endometriosis remains less than clear at this time. However, researchers suggest that the focus should shift to understanding the overall impact of obesity on Endometriosis in terms of disease severity. The study’s lead author, Sarah Holdsworth-Carson, PhD, explains, “this study has important clinical applications, with surgeons now aware of the need to provide more time for surgery in obese women as they are more likely to have extensive Endometriosis requiring removal.”
Uterine Fibroid Treatment Techniques Continue to Improve
While the formation of fibroid tumors in the uterus are non-cancerous, for many women they can result in symptoms including pain and heavy bleeding. There are a number of techniques for treating this condition that have been around for years, the most drastic of which are characterized by the more than 200,000 hysterectomies that are performed every year. Improvments in treatment options continue to be developed however, using less invasive techniques which focus on preserving future fertility.
Targeted fibroid surgery is nothing new. Nor is the use of hormone-blocking drugs which, by mimicing the effects of menopause, may cause fibroids to shrink prior to surgical removal. By using this therapy to reduce the size of uterine fibroids, the size of incisions required for their removal is also reduced. While these drugs are often effective in temporarily reducing the symptoms caused by uterine fibroids, patients must live with side effects that also mimic those of menopause including hot flashes, sweating and vaginal infections. This is why these treatments are not generally prescribed as a long term solution since other side effects, also consistent with menopause like bone loss, can occur.
While another still less invasive technique called Fibroid Embolization was developed some years ago, newly developed enhancements to the treatment are providing significant benefits for patients. Fibroid Embolization works by blocking the blood flow which feeds the fibroid and allows it to grow. With this procedure, specific “feeder” blood vessels are targeted, after which a thin catheter is threaded to the precise location where the blood vessel meets the fibroid. The blood vessel is then blocked by insertion of microscopic inert particles through the catheter leaving the fibroid to starve, shrink and die.
Traditionally, the catheter has been inserted via the femoral artery in the groin area, but this came with a lengthy recovery process which required the patient to lay motionless for approximately six hours due to bleeding risk at the insertion point. As medical professionals have continued to look for less invasive ways to achieve successful outcomes, new insertion points through smaller arteries are now being used. Surprisingly, doctors have recently discovered that the same “blocking” effects can be realized using a catheter insertion point in the wrist. This technique requires an extremely short recovery time, saving patients a great deal
of discomfort, making the traditional treatment of Fibroid Embolization not so traditional and far
more tolerable.
New Research Study Evaluates Oral Medication to Reduce the Severity of Endometriosis Symptoms
The Equinox Study is a clinical research project designed to evaluate the effectiveness of an oral medication to mitigate moderate to severe Endometriosis pain. The investigational medication works by reducing the amount of estrogen produced in the body without blocking it completely. For women who have tried many options in the past without success this study may offer a no-cost opportunity for relief.
In order to qualify for participation in the study subjects must be between the ages of 18 and 49, have been surgically diagnosed with Endometriosis within the last 10 years, and be experiencing moderate to severe pain due to the condition. Participants must not be pregnant or actively trying to become pregnant, and must not be suffering from any type of bone disease.
The first half of the study period a control group of participants will receive a placebo which will appear identical to the actual investigational medication, but will contain no medication. In the second half of the study however, all participants will receive the active medication. Participants will be closely monitored by the study team (nurses/clinicians) under the guidance of the study doctor.
More detailed information about the pros and cons of participating in the study can be found at www.equinoxstudy.com/.
New Oral Medication for Treatment of Uterine Fibroids Will Face Delay
The FDA has extended the New Drug Application (NDA) review period for Ulipristal Acetate (UA), an oral medication for the treatment of uterine fibroids, to August of this year (2018).
Ulipristal Acetate, already available in Europe and Canada, is approved for the pre-operative and intermittent treatment of uterine fibroid symptoms in adult women of reproductive age. Currently in the US, treatment options for the symptoms of uterine fibroids, including pain and abnormal bleeding, are mostly surgical. While these treatments are effective, they can result in recovery times that may extend for weeks. The availability of UA would present an alternative for women suffering from untreated fibroid symptoms either because they were unwilling or unable to accept the potentially extended recovery period.
UA is a selective progesterone receptor modulator (SPRM), which acts directly on progesterone receptors, blocking progesterone from feeding the fibroids, and causing them to shrink in size. The medication works on three target tissues: the endometrium or uterine lining, the uterine fibroids and the pituitary gland. Studies have shown that the treatment effectively reduces, or stops, abnormal vaginal bleeding within 5 to 6 days.
During treatment, one pill is taken daily for a 3-month period and then stopped for 1 menstrual cycle to allow the shedding of the uterine lining. Unlike the injectable Lupron, the only medication currently on the market in the US for the treatment of uterine fibroids, UA appears to have fewer side effects. Lupron essentially sends women into early menopause, which brings with it the associated symptoms of menopause like hot flashes and bone loss. The UA medication, while it does have some side effects, produces none similar to those of menopause.
While hysterectomy remains the most common treatment for uterine fibroids, it is not a viable option for women who still wish to undergo childbirth in the future. Currently, a myomectomy (surgical removal of the fibroids that leaves the uterus intact) is generally considered to be the best option in this case. Should UA become available in the US, the drug could represent an effective, less invasive alternative to surgery.
Epic Fail at Cleveland’s University Hospital Spurs Changes for Patients and Fertility Centers
Two months after Cleveland’s University Hospitals’ epic loss of more than 4,000 frozen embryos, patients are focusing on the structural security of fertility clinics like never before.
During the overnight hours of March 3rd and 4th, one of the cryo-tanks in CUH’s fertility center began warming beyond critical levels. Tanks such as these contain sensors that monitor temperature, and are designed to trigger an alarm well in advance of temperatures warming to critical levels. In this case however, no alarm was sounded. Apparently, the liquid nitrogen auto-fill mechanism had malfunctioned overnight. The temperature gradient from the top to the bottom of the tank meant that some embryos and eggs remained viable, while others were compromised, further adding to the uncertainty of the situation.
Initially, the hospital claimed that 2,000 egg and embryo specimens had been affected, however in late March the number cited by CUH had doubled to 4,000 samples impacting 1,000 patients.
This failure was widely reported in the news, and has caused patients to consider the technical infrastructure of the fertility center they choose with far greater scrutiny. It has also produced a significant reaction throughout the IVF industry. The fact that patients now want to know about alarms systems, redundancy and specimen security in general, prior to selecting a given facility, has moved many to upgrade their storage and alarm technology in order to remain competitive. While many leading fertility clinics, particularly those in major cities, have implemented the latest security technology for years, many previously reluctant players in the market are now scrambling to get on board.
Today’s cutting edge alarm systems, like the Temp@lert Z-Point Wireless System, have built-in levels of redundancy. These systems also feature multiple modes of contact for both notifying personnel of temperature changes (email, text, phone and on-site), but they also feature advanced data logging capabilities as well. This enables clinics to provide documented proof of continual performance throughout the facility (incubators, cryo-tanks, etc.).
It remains to be seen whether or not Cleveland’s University Hospitals fertility center will survive this catastrophic disaster as multiple lawsuits have already been filed against the operation. One thing is certain however: this incident has permanently altered the way patients will select a fertility center, and how the IVF facilities will need to address specimen security if they hope to survive.
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