Genitourinary Syndrome of Menopause Statement Stresses Tx Options

Tara Haelle

October 19, 2020

It's important for clinicians to ask women whether they are experiencing symptoms of genitourinary syndrome of menopause (GSM) before and after menopause, according to a new statement from the North American Menopause Society (NAMS).

Dr Stephanie Faubion

Stephanie Faubion, MD, MBA, medical director of NAMS, presented the updated statement at the virtual North American Menopause Society (NAMS) 2020 Annual Meeting.

"The one thing we tried to emphasize is proactive counseling and proactive inquiry, educating women when they hit perimenopause that this is a thing and that there are treatments," Faubion told Medscape Medical News in an interview.

"I think women sometimes think there's nothing they can do, which is not true. There's the misperception that it's just part of getting old, which it's not," said Faubion, who is also director of the Mayo Clinic Center for Women's Health and chair of the Mayo Clinic Department of Medicine in Jacksonville, Florida.

Changes From Previous Statement

The GSM statement describes the symptoms and signs resulting from estrogen deficiency on the genitourinary tract, Faubion explained. The biggest change from the earlier version, published in 2013, is the condition's new name. Formerly known as vulvovaginal atrophy, the condition's new term was developed in 2014 and is now preferred by NAMS and the American College of Obstetricians and Gynecologists (ACOG) because it's more comprehensive. Rather than just a physical description of the condition, GSM encompasses the many related symptoms and the urinary tract changes that occur, and it clearly associates the condition with menopause.

"Women don't always associate these changes with menopause and don't recognize that there's something that can be done about it," Faubion said. "We like to emphasize that sex should never be painful, but it's not just about sex. It's about comfort."

Other changes include a review of evidence related to vaginal laser therapy for GSM and the availability of Imvexxy vaginal inserts with lower doses (4 mcg and 10 mpg) of estrogen.

Etiology and Diagnosis of GSM

The presence of endogenous estrogen keeps the vaginal lining thick, rugated, well-vascularized, and lubricated. As estrogen levels decline during postmenopause, the epithelial lining becomes thinner, with reduced blood supply and loss of glycogen.

The most common symptoms of GSM include irritation of the vulva, inadequate vaginal lubrication, burning, dysuria, dyspareunia, and vaginal discharge, but the symptoms may not always correlate with physical findings. In women with surgical menopause, the symptoms tend to be more severe. The most distressing symptoms to women are often those that affect sexual function.

"Clinicians must be proactive in asking menopausal women if GSM symptoms are present, even before menopause begins," Faubion said.

Taking a women's history during evaluation may help identify contributing factors, other causes, or potentially effective treatments based on what has worked in the past. History should include a description of symptoms, their onset and duration, how distressing they are, and their effect on the woman's quality of life. A sexual history, such as lubricants the woman has used, can also be useful in determining management strategies.

Signs of GSM include labial atrophy, vaginal dryness, introital stenosis, clitoral atrophy, phimosis of the prepuce, reduced mons pubis and labia majora bulk, reduced labia minora tissue and pigmentation, and changes in the urethra, including erythema of the urethral meatus and commonly a urethral caruncle, a benign outgrown of inflammatory tissue that likely results from low estrogen levels and can be treated effectively with topical hormonal therapies.

A diagnosis of GSM requires both physical findings and bothersome symptoms, though not necessarily specific vaginal maturation index or vaginal pH values. The differential diagnosis speaks to the importance of taking a good history: allergic or inflammatory conditions, infection, trauma, presence of a foreign body, malignancy, vulvodynia, chronic pelvic pain, or provoked pelvic floor hypertonia.

If first-line therapies of over-the-counter lubricants do not sufficiently treat GSM, other effective treatments include low-dose vaginal estrogen therapy, systemic estrogen therapy if other menopause symptoms are present, vaginal dehydroepiandrosterone (DHEA), and ospemifene.

Management of GSM

First-line therapy of GSM involves over-the-counter lubricants and moisturizers, which are often adequate to alleviate or eliminate women's symptoms. However, the panel that developed the statement found no evidence that hyaluronic acid was any more effective than other lubricants or moisturizers, and no herbal products were found to effectively treat GSM.

While emerging evidence suggests that energy-based therapies, such as treatments with vaginal laser or radio-frequency devices, show some promise, more evidence is needed to show safety and efficacy before the panel can recommend routine use.

When over-the-counter therapies are not effective, vaginal estrogen usually relieves GSM with little absorption and is preferred over systemic therapy if GSM is the only bothersome menopausal symptom. Options include topical creams, a slow-release estradiol intravaginal ring, and estradiol vaginal tablets and inserts.

"However, when systemic hormone therapy is needed to treat other menopause symptoms, usually a woman will derive benefit and resolution of the GSM at the same time," Faubion said. "However, for some women, additional low-dose vaginal estrogen may be added to systemic estrogen if needed, and that could include vaginal DHEA."

All the approved vaginal products have shown efficacy compared with placebo in clinical trials, and a Cochrane review comparing the different therapies found them to be similarly efficacious in treating vaginal dryness and dyspareunia with no significant differences in adverse events.

Preparing Patients for the Boxed Warning

As vaginal estrogen doses are significantly lower than systemic estrogen, their safety profile is better, with serum estrogen levels remaining within the postmenopausal range when low-dose vaginal estrogen therapy is used. That said, some studies have shown that vaginal estrogen cream can be a large enough dose to involve systemic absorption and lead to symptoms such as vaginal bleeding, breast pain, and nausea.

However, package inserts for vaginal estrogen have the same boxed warning as seen in systemic hormone therapy inserts regarding risk of endometrial cancer, breast cancer, cardiovascular disorders, and "probable dementia" despite these conditions not being linked to vaginal estrogen in trials. Neither has venous thromboembolism been linked to vaginal estrogen.

"The panel felt it was very important that women be educated about the differences between low-dose vaginal estrogen and systemic estrogen therapy and be prepared for this boxed warning," Faubion told attendees. "It's really important to say, 'You're going to get this, it's going to look scary, and there's no evidence these same warnings apply to the low-dose vaginal estrogen products.' "

Dr Juliana (Jewel) Kling

This point particularly resonated with NAMS attendee Juliana (Jewel) Kling, MD, MPH, an associate professor of medicine at the Mayo Clinic Arizona in Scottsdale.

"The point about educating women about the differences between low-dose vaginal estrogen products and systemic treatments and being prepared for the boxed warning is important and I hope reaches many practitioners," Kling told Medscape Medical News.

The panel did not recommend using progestogen with low-dose vaginal estrogen therapy or doing routine endometrial surveillance in women using vaginal estrogen. But endometrial surveillance may be worth considering in women with increased risk of endometrial cancer.

Estrogen insufficiency from premature menopause or primary ovarian insufficiency is linked to more severe sexual dysfunction, which can be particularly upsetting for younger women with vaginal atrophy and dyspareunia. A meta-analysis showed that vaginal estrogen appeared to slightly outperform OTC lubricants in bringing back sexual function.

Undiagnosed vaginal or uterine bleeding is a contraindication for vaginal estrogen until the cause has been determined, and providers should use caution in prescribing vaginal estrogen to women with estrogen-dependent neoplasia. Faubion noted that GSM is common in women with breast cancer, especially if they are receiving endocrine treatments or aromatase inhibitors.

"For women with a hormone-dependent cancer, GSM management depends on each woman's preference in consultants with her oncologist," she said. GSM management in women with a nonhormone-dependent cancer, however, is no different than in women without cancer.

DHEA is a steroid that effectively improves vaginal maturation index, vaginal pH, dyspareunia, and vaginal dryness. The most common side effect is vaginal discharge.

Ospemifene, an estrogen agonist available in the US but not in Canada, is the only oral product approved to treat vaginal dryness and dyspareunia. An observational study also found it effective in reducing recurrent UTIs. The most common side effect is vasomotor symptoms, and it should not be used in patients with breast cancer because it hasn't been studied in this population.

"This updated information and position statement was needed and will be very clinically relevant in treating midlife women," Kling told Medscape Medical News. "Dr Faubion presented a high-level overview of the position statement with clinically relevant points, including treatment for sexual dysfunction related to GSM, GSM treatment in cancer patients, and emphasized the efficacy and low-risk safety profile of low-dose vaginal estrogen, compared to systemic HT, for treatment of GSM."

Faubion and Kling have disclosed no relevant financial relationships.

Follow Medscape on Twitter @Medscape and Tara Haelle @tarahaelle.

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