Menopausal Women: Clearing up the Controversies

By:  Linda Harder

Photography By: Tracey Brown and Randy Sager

Maryland Physician spoke with women’s health experts to provide the latest medical information on common issues in middle-aged women – osteoporosis, hormone replacement therapy and pelvic prolapse. Here is their advice.

Abdominally Placed Pelvic Mesh is Safe

An estimated 3.3 million U.S. women have pelvic prolapse, and that number is expected to grow by about 50% in the next few decades as women live longer. Victoria Handa, M.D., FACOG, professor of Obstetrics/Gynecology and director, Advanced Training Program in Female Pelvic Medicine and Reconstructive Surgery at Johns Hopkins Bayview Medical Center, hopes to clarify several critical misconceptions about pelvic prolapse and how to best treat it.  “Sometimes even among OB/GYNs who don’t see many women with prolapse, there’s a misunderstanding about what prolapse is, and a tendency to confuse it with bowel and bladder function issues. Women often have more than one issue and when they call me saying they have a dropped bladder, they mean they have a non-functioning bladder. They may or may not have pelvic prolapse.”

In the past, pelvic support defects were labeled by the organ that was prolapsed (e.g., enterocele or cystocele). The current convention is to classify the prolapse based on where it is and how severe it is. Anterior and posterior compartment prolapses herniate toward the front and back of the vagina, respectively, while in apical compartment prolapses, the top of the vagina (and sometimes uterus) fall down. In severe pelvic prolapse, the uterus protrudes outside the vaginal entrance.

Evaluation

The primary assessment for pelvic prolapse is a history and physical exam. If bowel and bladder issues coexist, the physician may also evaluate those. “Patients occasionally, but not normally, need imaging. We can usually deduce the type of prolapse from the physical exam,” explains Dr. Handa.

Treatment Options

Non-surgical approaches for pelvic prolapse generally consist of pelvic muscle strengthening exercises and/or a pessary. Dr. Handa notes, “I tell patients that the pessary is a supportive device. Like contact lenses, it doesn’t make the problem go away, but it can relieve your symptoms. Some women use the pessary until surgery, while others may use it long term.”

Pelvic muscle exercises typically involve weekly physical therapy for about two months. “Usually, if a woman doesn’t have a benefit within three months, we discontinue it.”

Surgery can be performed vaginally, with an abdominal incision, laparoscopically or robotically.

“In the past few years, our thinking has changed and we focus more on apical prolapse, pulling the top of the vagina up. Surgical repairs that don’t provide support to the vaginal apex are not as successful in the long term. The good news is that, over the past 10 to 15 years, we’ve accumulated good scientific data to guide us. Sacropexy  is considered the gold standard.”

If the patient has bowel and bladder issues for which surgery is appropriate, surgeons can address those in the same procedure.

Misunderstandings About Mesh

Dr. Handa is dismayed by inaccurate perceptions about the safety of mesh used in prolapse repair that have resulted from recent FDA advisories concerning a specific class of surgeries that include transvaginal implantation of mesh.

In 2009, the FDA issued an advisory that reported increased complications from transvaginal mesh products. In 2012, they issued a second advisory. “However, the advisory only pertains to a very narrow class of mesh that is placed transvaginally to treat prolapse, which I’ve never used. It does not pertain to mesh placed abdominally or to treatment for stress incontinence,” underscores Dr. Handa. “Unfortunately, the FDA advisory keeps many women from coming in and makes them unnecessarily afraid to have any type of surgery for their prolapse.  Physicians need to help address this misconception with accurate information such as that at the FDA website (www.FDA.gov).”

New FPMRS Subspecialty Board

Another positive development in prolapse treatment is that there are a growing number of specialists in Female Pelvic Medicine and Reconstructive Surgery (FPMRS). This year for the first time, urologists and gynecologists who have specialized training can pass a rigorous exam to become boarded in this subspecialty.

“Until now, it’s been hard to know what credentials to look for,” Dr. Handa states. “This certification will help referring physicians and patients know who has the expertise. Over time, hospitals will change their credentialing process accordingly.”

Osteoporosis: Who Should be Treated and When?

Surprisingly, far more women have osteoporotic fractures than new strokes, heart attacks or invasive breast cancer combined. The National Osteoporosis Foundation (NOF) estimates that more than 10 million Americans have this condition, and nearly half of all Caucasian women and about 20% of men will have an osteoporotic fracture in their lifetime. While fractures have declined in the past few decades, less than one third of osteoporosis cases have been diagnosed and only one seventh of U.S. women with osteoporosis receive treatment.

DXA Recommendations

The NOF recommends that all men over 50 and all post-menopausal women be evaluated clinically for their osteoporosis risk; those at higher risk should receive dual-energy x-ray absorptiometry (DXA) prior to age 65; women not at risk should receive DXA at age 65 (men at age 70), and typically every two years thereafter.

“Two to three years post menopause is when the greatest bone loss occurs,” says James Mersey, M.D., an endocrinologist at GBMC. “Age, sex, weight, family and personal history of fracture, smoking, drinking, certain diseases such as rheumatoid arthritis and corticosteroid use are among the key risk factors.”

Dr. Mersey says, “The average 70 year old female has osteoporosis, and anyone with osteoporosis is at increased risk of fracture. Anyone who has lost height, is on steroids, has hyperthyroidism, smokes or drinks, or who has a family history, should get a DXA.  Diabetes also increases the risk. If on therapy, the DXA should be repeated yearly. After two normal DXA scans, getting scanned every three to five years is reasonable. “

Diagnosis

DXA generates a T-score that compares the patient’s bone density to the optimal bone density for others of the same sex and ethnic group. A T-score greater than -1 is considered normal. A score of -1 to -2.5 implies a higher risk of developing osteoporosis, and a score of -2.5 is diagnostic.

The ten-year risk of a fracture can be measured using a fracture risk assessment (FRAX) tool developed by the World Health Organization. It uses a computer algorithm that takes into account age, sex, weight and height, and other variables. Patients can calculate their approximate risk online even without having their bone mineral density (BMD) tested.

Treatment

If the FRAX score indicates osteoporosis, the patient is typically referred to an endocrinologist or rheumatologist for treatment. A metabolic work-up provides information about the underlying cause of the disease, measuring thyroid hormones, serum CTX, urine calcium, Vitamin D levels and more.  “Currently, there is no indication for Vitamin D supplements other than bone health,” notes Dr. Mersey.

“Before you treat  osteoporosis, you should measure 25 hydroxy vitamin D and if necessary,  restore vitamin D levels to the normal range. If not most therapies run the risk of causing sustained low calcium levels, or at least being ineffective,” Dr. Mersey advises. “We typically provide 50kl units per week for six or more weeks, and then take a second level to see if we need to continue it.”

The use of bisphosphonates (BPs) has been controversial in recent years, but research data supports its use in women with:

  • Hip or vertebral fracture
  • BMD <-2.5 at the lumbar spine or femoral neck
  • Low BMD and 10-year risk of hip fracture >3%

The data also demonstrates that serious side effects with BPs are uncommon. Dr. Mersey comments, “I’ve treated 5000 patients with Fosamax and have never seen anyone develop osteonecrosis and have only seen one patient with an atypical femoral fracture. We still don’t know how long it’s ideal to use BPs, however. At five years, we give a break in treatment if the bone density is improved. If it is still low and at high risk for fracture, we continue treatment. In 2013, the choices for therapy haven’t broadened, but we have better data about what works.”

The key issue with oral BPs (e.g., alendronate, risedronate) is low adherence – typically, half of patients are not taking them appropriately.  Dr. Mersey often recommends a yearly injection of parenteral therapy (e.g., zoledronic acid) or a semiannual injection of Prolia to ensure that patients get the appropriate dose.

Other commonly prescribed medications include Forteo, the only anabolic therapy for bone loss –  appropriate for many patients for two years. After bone density has increased, physicians switch their patients to other therapies to maintain bone density.

Prolia, a monoclonal antibody, is a powerful anti-resorptive agent injected every six months for women who cannot take BPs. Dr. Mersey explains, “We want it to wear off so the bone turnover rate is not zero, creating more flexible bone. There’s a slight risk of dermatitis, but there are no immediate side effects and even dialysis patients can be on this therapy. Patients must have adequate Vitamin D levels, however.”

He concludes, “A common misunderstanding about osteoporosis treatment is that older women don’t need it. But it can reduce the risk of another spinal fracture by 70% and a hip fracture by 25% in one year, preventing many women from hospitalization and a downward health spiral. It’s the quality of life, not how long it prolongs life, that’s important.”

Hormone Replacement: Safe After All?

The Women’s Health Initiative study (a 15-year research study launched in 1991) raised significant questions about the safety of hormone replacement therapy (HRT) for older women.  Since the study was discontinued in 2002, however, researchers have reassessed the data from that study and determined that HRT can be a safe and even invaluable aid to many women in the peri-menopausal and early menopause years. Several major professional societies now consider HRT to be the most effective available treatment.

Darryn Band, M.D., OB/GYN with Capital Women’s Care and an associate clinical professor at George Washington University, says, “The WHI study found a slightly higher risk of stroke, coronary artery disease and breast cancer, but the average patient in their study was heavier, aged 65 or older and many were smokers, so it was not a fair comparison. These effects were limited to those participants taking combination oral HRT. The estrogen-only group (those who had had hysterectomies) did not have an increased risk of breast cancer.”

Women who have an intact uterus must take progesterone along with estrogen to prevent hyperplasia and the risk of uterine cancer. Dr. Band continues, “The study scared women to the extent that the percent of peri-menopausal or menopausal women using HRT has declined from about 50% in 2002 to 25 – 30% today. Today, many experts feel there are significant health benefits to women who begin HRT at the onset of menopause. A clear benefit is the relief of vasomotor symptoms and urogenital health, including urinary urgency, possible decrease in recurrent UTIs and relief of vaginal atrophy. In addition, HRT has been shown to reduce the risk of colon cancer and improve bone health.

“Our goal is to improve quality of life and provide therapy for symptom relief for as short a time as possible,” he adds. “Many GYNs feel we’ve done a disservice to women. The pendulum is definitely swinging back.  In fact, more GYNs are starting to use estrogen and progesterone to alleviate symptoms of peri-menopause, which include irregular vaginal bleeding and mood lability. These symptoms result from rapid fluctuation in hormone production, which settle down following menopause.”

The key is the route of administration and using the lowest dose for the shortest possible time.  “Some have suggested that transdermal and transvaginal administration may reduce some of these risk factors by bypassing the liver.”

There are other options for those not interested in hormones. New products such as IsoRel, a soy isoflavone supplement, help with mild to moderate hot flashes. However, black cohosh and fish oil have not been proven effective.

A group that includes premature ovarian failure prior to the average age of 51,  spontaneous or post oopherectomy, may benefit from hormone replacement therapy. It has been shown that these women have higher morbidity and mortality than women with normal hormonal production.

Dr. Band concludes, “HRT should be used for those women that are having severe vasomotor symptoms, issues of well-being or urogenital issues.  It should not be used for primary prevention of heart disease or osteoporosis.”

Victoria Handa, M.D., FACOG, professor of Obstetrics/Gynecology and director, Advanced Training Program in Female Pelvic Medicine and Reconstructive Surgery at Johns Hopkins Bayview Medical Center

James Mersey, M.D., endocrinologist, GBMC

Darryn Band, M.D., OB/GYN with Capital Women’s Care and an associate clinical professor at George Washington University


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