Project Summary

This project is ongoing and does not have results.

The Patient-Centered Outcomes Research Institute is partnering with the Agency for Healthcare Research and Quality to develop a systematic evidence review on genitourinary syndrome of menopause (GSM). The American Urological Association (AUA) plans to use this systematic evidence review to develop related clinical guidelines.

Genitourinary syndrome of menopause is a term that describes the spectrum of symptoms and signs caused by hypoestrogenic changes in urogenital tissues typically occurring during menopause, but which can also occur among premenopausal women under certain circumstances. The term GSM was introduced in 2014 by the International Society for the Study of Women's Sexual Health and the North American Menopause Society to encompass a constellation of conditions including vulvovaginal atrophy, atrophic vaginitis, or urogenital atrophy.

Symptoms of GSM may include vulvovaginal dryness, burning, and irritation; sexual symptoms such as of lack of lubrication, discomfort or pain, or impaired function; and urinary symptoms of urgency, dysuria, or recurrent urinary tract infections. Although not all individuals with atrophic changes on examination are symptomatic, it is estimated that over half of postmenopausal women in the United States experience atrophy-related symptoms. The negative effect of GSM on quality of life is substantial; as many as 85 percent of patients over 40 years of age report vaginal dryness, 29 percent to 59 percent report dyspareunia (persistent or recurrent genital pain that occurs just before, during, or after sex), 26 percent to 77 percent report vaginal itching and irritation, and 40 percent to 68 percent report negative consequences on their sex life, including decreased sexual satisfaction and frequency. Unlike menopause-associated vasomotor symptoms (e.g., hot flashes, night sweats, heart palpitations, and changes in blood pressure) that tend to decrease over time, GSM symptoms do not spontaneously remit but worsen with age.

Despite the high prevalence of symptoms, only a small minority of affected women seek help. An unfortunate barrier to treatment is that women believe symptoms of GSM are a normal consequence of aging that they must accept. As a result, women rarely discuss symptoms with their healthcare provider and providers do not consistently ask about symptoms.

The primary goal for the treatment of GSM is to relieve symptoms. Determining which type of treatment is appropriate for a patient is based on the patient’s medical history (such as GSM symptoms and co-morbidities) and preferences. Based on limited evidence, nonhormonal vaginal moisturizers and lubricants have been recommended as first-line therapy for GSM symptoms related to vaginal atrophy (e.g., vaginal dryness, dyspareunia, etc.). Other nonhormonal therapies proposed as alternatives include oral vitamin D, vaginal vitamin E, probiotics, and phytoestrogens. Prescription hormones are also available for GSM treatment and include vaginal and low-dose oral estrogen, vaginal dehydroepiandrosterone, vaginal testosterone, and oral ospemifene. A body of evidence has shown that vaginal and low-dose systemic estrogen therapy are effective for treating many symptoms of GSM and also may ameliorate some urinary tract symptoms of GSM. A comprehensive analysis of the benefits and harms of treatments for GSM has not been completed in several years and new data on these more established therapies has subsequently accumulated.

In addition to the need for an updated comprehensive assessment of treatments for GSM that have been in use for many years, the role of newer treatments needs to be understood as well. Several novel treatments have recently emerged, including laser and radiofrequency devices (e.g., microablative fractional CO2, nonablative erbium: YAG [Er:YAG], and temperature-controlled radiofrequency laser). Despite initial excitement, use of these new therapeutic approaches is controversial and an independent review of the evidence on benefits and harms would be valuable.

Although a handful of recent position and consensus statements on the management of GSM exist, a clinical practice guideline based on an independent systematic review of the evidence has yet to be produced. Consequently, a review that synthesizes the totality of evidence available on the benefits and harms of screening, diagnosis, and treatment of GSM is needed to support the development of a clinical practice guideline and to inform decision making for healthcare professionals, clinicians, patients, and caregivers.

Proposed Key Questions

  1. What is the effectiveness and harms of screening strategies to identify GSM in peri- or postmenopausal women? Does screening reduce patient-reported symptoms or improve quality of life?
  2. What is the efficacy and comparative effectiveness of hormonal, nonhormonal, and energy-based interventions when used alone or in combination for treatment of GSM? Which treatments show improvement for which symptoms?
  3. What are the harms (and comparative harms) of hormonal, nonhormonal, and energy-based interventions for GSM?
  4. What is the appropriate follow-up interval to assess improvement, sustained improvement, or regression of symptoms of GSM in women treated with hormonal, nonhormonal, and energy-based interventions?
  5. What is the effectiveness and harms of  surveillance among women who have a uterus and are using vaginal or low-dose oral estrogen therapy?

For all key questions, how do the findings vary for women with a history of breast cancer or other hormone-related cancers, a high risk of cancer, or conditions such as primary ovarian insufficiency; women experiencing surgical menopause or transgender men; and subgroups defined by severity of GSM symptoms and patient characteristics (i.e., by age, race, socioeconomic status, etc.).

More on This Project

Project Information

Agency for Healthcare Research and Quality (AHRQ)
$742,350

Key Dates

2022

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Last updated: January 26, 2024