Genitourinary syndrome of menopause (GSM) — a refresher

Authors

Kerstin Gustafson, MD, FRCSC (biography and disclosures)

Disclosures: Received payments as honoraria for speaking on various medical topics, both from for-profit organizations and from non-profits such as the SOGC. Served on regional advisory boards for Amgen, Lilly, Pfizer, Bayer, Sanofi, and Novartis. Mitigating potential bias: Only published trial data is presented. Recommendations are consistent with clinical trial data and published practice guidelines.

Colleen Dy, MD, FRCS(C), NCMP (biography and disclosures)

Disclosures: Received speaking honoraria from Pfizer, Merck, BioSyent Inc. Speaker for Pfizer on Genitourinary Syndrome of menopause (Premarin cream). Mitigating potential bias: Recommendations are consistent with current practice patterns.

What frequently asked questions/gaps we have noticed

The lower genital tract changes of menopause are collectively called the genitourinary syndrome of menopause (GSM). GSM encompasses vulvovaginal atrophy (VVA) and lower urinary tract symptoms (LUTS).¹ This makes sense physiologically as the vulva, vagina, lower urinary tract, and pelvic floor have the same embryologic origin, and accordingly share similar hormone responsiveness.² GSM affects up to 70% of post-menopausal women. Symptoms such as burning, itching, or irritation of the vulva; lack of lubrication and vaginal dryness; and discomfort or pain with sexual activity are common. Burning on urination, increased frequency or urgency of urination, and increased risk for urinary tract infections also can occur.³

The VIVA study showed that over 50% of Canadian women were unaware of treatments for these conditions, and 59% of women reported that their doctor had not raised the subject of post-menopausal genital health.³  The associated CLOSER study showed that over 50% of women find GSM distressing and affecting sexual function, well-being, and even causing depression.⁴ The most common complaint of GSM is vaginal dryness in up to 93% of women.⁵

A large percentage of women do not receive treatment for GSM, attributable to both patient and physician reluctance to discuss the topic.³ Up to now, the “Gold Standard” recommendation for GSM has been vaginal estrogen. However, vaginal estrogen may not be acceptable or indicated for some patients. Some patients will not accept estrogen-based therapies despite reassuring safety data. Newer preparations for treating GSM have been introduced to Canada and may offer relief for some patients who might otherwise not consider treatment.

Data that answers these frequent questions/gaps

First-line therapies to alleviate symptoms of GSM include over-the-counter (OTC) non-hormonal vaginal lubricants and moisturizers, a number of which are available, but few clinical studies have been conducted on the efficacy of these products.⁶

Vaginal estrogen preparations are an effective treatment for GSM for many women. These include vaginal estrogen creams, suppositories, tablets, and a vaginal ring. Women should be informed that local vaginal estrogen is not systemic hormone therapy (HT) and does not carry the risks of HT,⁷ when used at recommended standard doses,⁸ and may be used without progestin. Vaginal inserts and suppositories are most likely to impact the upper vagina and may not treat GSM symptoms of the urethra and vulva in all patients. Women who have a history of breast cancer may be offered low-dose vaginal estrogen off-label for severe GSM, according to current guidelines from both the North American Menopause Society (NAMS) and the Society of Obstetricians and Gynaecologists of Canada (SOGC),^6,9 in consultation with their oncologist.

Ospemifene is a daily oral selective estrogen receptor modulator (SERM) indicated to treat vulvovaginal atrophy (VVA). An oral product is a valuable alternative as intravaginal products may have limitations in older women and particularly in patients with concomitant disease states such as arthritis or mobility challenges, which may make the application of these products difficult. In addition, many women have a personal preference for an oral treatment. As an oral medication, it has some systemic effects: in pre-clinical models, ospemifene is an antiresorptive agent on bone and antagonistic to breast cell proliferation, similar to the effect of raloxifene on those tissues. It is contraindicated in patients with a history of breast cancer, and it may increase the risk of venous thromboembolism (VTE) similar to other SERMs.¹⁰

A low-dose DHEA (prasterone) vaginal insert used daily with an applicator was recently approved in Canada for the treatment of moderate to severe dyspareunia in menopausal women. DHEA is a steroid hormone that is an intermediate in the biosynthesis of androgens and estrogens. It is a daily vaginal insert. Like vaginal estrogen, it may help with multiple symptoms of GSM.¹¹ DHEA does not carry a contraindication for a history of breast cancer.

Alternative and complementary treatments for GSM generally have little randomised controlled trial (RCT) evidence and have varying documented successes. For example, while vaginal laser treatment has become increasingly popular, a recent study showed no improvement compared to sham treatment after 1 year.¹²

What we recommend (practice tips)

Women should be proactively educated on the changes in the genital tract after menopause at routine visits, rather than waiting for patients to bring up the subject. We suggest incorporating questions alongside bowel and bladder review of systems. While women have many different manifestations of GSM, the most common complaint is vaginal dryness, so “Do you have any vaginal dryness?”, would be a sensitive single question for practitioners not currently asking about genital health routinely. Unlike vasomotor symptoms, GSM often continues to worsen with time if untreated, and patients should be made aware that they cannot just “wait it out.”

Simple measures such as daily use of a vulvar moisturizer and use of barrier creams to protect the vulvar skin from irritants may be helpful, as are vaginal moisturizers. For menopausal women who have penetrative sex, the use of lubricants for intercourse should be recommended routinely. All women with vulvar and vaginal complaints in menopause should be offered a clinical exam to rule out secondary causes.

Many women will require pharmacotherapy in addition to non-hormonal treatments. Patients should be offered a route and preparation that is agreeable to them, and there is an increasing number of options. Expectations should be realistic and include that it may take 2 months or more to achieve clinical improvement with all hormone treatments. Also, patients who have had prolonged symptoms of GSM may have developed secondary vaginismus or vulvodynia and may require additional counselling and/or physical therapy.

Patient resources

1. Symptom Checklist: Vaginal Atrophy, When Sex Hurts. SIGMA Canadian Menopause Society. Accessed May 2, 2023. View PDF on sigmamenopause.com
2. Facts on Menopause from Canada’s Experts. The Society of Obstetricians and Gynaecologists of Canada (SOGC). Accessed May 2, 2023. View MenopauseandU.ca
3. Patient education: Vaginal dryness (Beyond the Basics). UpToDate®. Accessed May 2, 2023. View uptodate.com

References

1. 1. Portman DJ, Gass MLS, Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women’s Sexual Health and The North American Menopause Society. Menopause. 2014;21(10):1063-1068. doi:10.1097/GME.0000000000000329 (View with CPSBC or UBC)
   2. Johnston S, Bouchard C, Fortier M, Wolfman W. Guideline No. 422b: Menopause and Genitourinary Health. J Obstet Gynaecol Can. 2021;43(11):1301-1307.e1. doi:10.1016/j.jogc.2021.09.001 (View with CPSBC or UBC)
   3. Nappi RE, Kokot-Kierepa M. Vaginal Health: Insights, Views & Attitudes (VIVA) – results from an international survey. Climacteric. 2012;15(1):36-44. doi:10.3109/13697137.2011.647840 (View with CPSBC or UBC)
   4. Nappi RE, Kingsberg S, Maamari R, Simon J. The CLOSER (CLarifying Vaginal Atrophy’s Impact On SEx and Relationships) survey: implications of vaginal discomfort in postmenopausal women and in male partners. J Sex Med. 2013;10(9):2232-2241. doi:10.1111/jsm.12235 (Request with CPSBC or view with UBC)
   5. Angelou K, Grigoriadis T, Diakosavvas M, Zacharakis D, Athanasiou S. The Genitourinary Syndrome of Menopause: An Overview of the Recent Data. Cureus. 2020;12(4):e7586. Published April 8, 2020. doi:10.7759/cureus.7586 (View)
   6. The NAMS 2020 GSM Position Statement Editorial Panel. The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society. Menopause. 2020;27(9):976-992. doi:10.1097/GME.0000000000001609 (View with CPSBC or UBC)
   7. Manson JE, Goldstein SR, Kagan R, et al. Why the product labeling for low-dose vaginal estrogen should be changed. Menopause. 2014;21(9):911-916. doi:10.1097/GME.0000000000000316 (View with CPSBC or UBC)
   8. Santen RJ, Mirkin S, Bernick B, Constantine GD. Systemic estradiol levels with low-dose vaginal estrogens. Menopause. 2020;27(3):361-370. doi:10.1097/GME.0000000000001463 (View)
   9. Johnston S, Bouchard C, Fortier M, Wolfman W. Guideline No. 422b: Menopause and Genitourinary Health. J Obstet Gynaecol Can. 2021;43(11):1301-1307.e1. doi:10.1016/j.jogc.2021.09.001 (View with CPSBC or UBC)
   10. Reid RL, Black D, Derzko C, Portman D. Ospemifene: A Novel Oral Therapy for Vulvovaginal Atrophy of Menopause. J Obstet Gynaecol Can. 2020;42(3):301-303. doi:10.1016/j.jogc.2019.10.039 (View with CPSBC or UBC)
   11. Collà Ruvolo C, Gabrielli O, Formisano C, et al. Prasterone in the treatment of mild to moderate urge incontinence: an observational study. Menopause. 2022;29(8):957-962. doi:10.1097/GME.0000000000002007 (View with CPSBC or UBC)
   12. Jang YC, Leung CY, Huang HL. Comparison of Severity of Genitourinary Syndrome of Menopause Symptoms After Carbon Dioxide Laser vs Vaginal Estrogen Therapy: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022;5(9):e2232563. Published Septemeber 1, 2022. doi:10.1001/jamanetworkopen.2022.32563 (View)

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