Research Spotlight: Vulvovaginal Discomfort Symptoms in women enrolled in a randomized trial evaluating treatment for genitourinary syndrome of menopause

Caroline Mitchell, MD, MPH, a physician-investigator in the Department of Obstetrics and Gynecology at Massachusetts General Hospital and an associate professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, is the lead author of a new Paper in the journal Menopause: The complexity of genitourinary syndrome of menopause: number, severity, and frequency of vulvovaginal discomfort symptoms in women enrolled in a randomized trial evaluating treatment for genitourinary syndrome of menopause

What was the question you set out to answer with this study?

Close to half of postmenopausal women have symptoms of genitourinary discomfort, also known as genitourinary syndrome of menopause (GSM), which includes symptoms such as dryness, decreased lubrication with sex, pain with sex, or irritation/burning/itching of the vulva or vagina. 

Grouping all of these reported symptoms and signs together as a syndrome (GSM) created a more inclusive and acceptable terminology for both patients and providers to discuss postmenopausal genitourinary discomfort, but the grouping may obscure:

• Granular differences in experience between individuals
•  Which symptoms or experience of symptoms might be responsive to certain treatments.
• Which symptoms are more likely to motivate people to seek treatment. 

Therefore, we wanted to know the full extent of symptoms in postmenopausal women who seek treatment for vulvovaginal discomfort after menopause.

What Methods or Approach Did You Use?

To investigate this, we completed a secondary analysis of enrollment data from a clinical trial of treatments for bothersome vaginal symptoms and sexual function in postmenopausal women. 

Participants were asked about the severity (0–3), frequency (in days per week) and location (vulvar or vaginal) of the following symptoms of GSM in the four weeks leading up to enrollment in the trial: 

• Itch
• Dryness
• Pain/soreness
• Irritation
•  Severity and frequency of pain with penetration 
• Vaginal discharge
• Urinary incontinence
• Urinary urgency. 

The frequency and concurrency of these symptoms have not been examined with this level of detail before.

What Did You Find?

The proportion of participants reporting each symptom of GSM in the trial was similar to what is reported in broader population-based surveys of postmenopausal women. 

The mean number of moderate to severe vulvovaginal symptoms experienced by trial participants in the month prior to enrollment was 3.4, with a range from one to seven. 

The most reported symptom across all severity categories was vaginal dryness, but the one most frequently rated as severe was pain with vaginal penetration. 

Among participants with no symptoms rated as severe, the most bothersome symptoms were:

• Pain with vaginal penetration (50%)
• Vaginal dryness (26%)
• Vulvovaginal irritation (12%), itching (7%) or soreness (5%)

Vaginal dryness was the symptom with the highest frequency with 53% of participants reporting experiencing it more than four days per week. 

For vaginal symptoms, 80% of participants reported that at least one of these symptoms occurred during or after sex.

What are the Implications?

Our data highlights the complexity of GSM symptoms in quantity, severity and frequency, suggesting that measuring distress, bother or interference may be the most comprehensive measure.

What are the Next Steps?

The next step to better treatment of GSM is changing guidance for approval of new medications, which currently focuses on a single "most bothersome symptom", rather than focusing on a holistic assessment of the overall burden of all symptoms. 

About the Massachusetts General Hospital

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. In July 2022, Mass General was named #8 in the U.S. News & World Report list of "America’s Best Hospitals." MGH is a founding member of the Mass General Brigham healthcare system.