By Rebecca H. Allen, MD, MPH, Editor
SYNOPSIS: This analysis of baseline questionnaire responses from 302 individuals enrolled in the MsFLASH Vaginal Health Trial demonstrated that the most commonly reported symptoms were vaginal dryness (94%), pain with vaginal penetration (84%), vulvovaginal pain and soreness (76%), and vulvovaginal irritation (73%). The symptom most often rated severe was pain with vaginal penetration (40%).
SOURCE: Mitchell CM, Larson JC, Reed SD, Guthrie KA. 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. Menopause 2023;30:791-797.
The genitourinary syndrome of menopause (GSM) describes the effect of lack of estrogen on the genital tissues that occurs in the postmenopausal period.1 The authors of this study had conducted a randomized controlled trial, the MsFLASH Vaginal Health Trial, that compared vaginal estrogen, vaginal moisturizer, and placebo for treatment.2 This current study describes details on the symptoms that participants reported in the baseline questionnaire.
The original trial enrolled postmenopausal women who reported at least one moderate to severe GSM symptom. They were aged 45 to 70 years and at least two years had elapsed since their last menses. Exclusion criteria included the use of hormonal medication in the past two months, antibiotics in the past month, or current vaginal infection.
Participants were asked to rate the severity and frequency of different symptoms, such as vulvar or vaginal itching, vulvar or vaginal pain and soreness, vulvar or vaginal irritation, vulvar or vaginal dryness, pain with penetration, the amount and odor of vaginal discharge, and vaginal burning. Symptoms were rated as mild, moderate, or severe. The participants chose which symptom was most bothersome for them and described the frequency of the symptom and whether it occurred with or after sex. Urinary symptoms also were queried. Demographic information was collected, and a pelvic examination to confirm the diagnosis of GSM and rule out other disorders was performed at baseline.
A total of 302 participants were enrolled, with the average age of 60.9 ± 4.1 years. The proportion of the population that was sexually active was 245/302 (91%). The mean number of moderate or severe vulvovaginal symptoms was 3.4 ± 1.5 in the four weeks before the trial began. The most commonly reported symptoms were vaginal dryness (94%), pain with vaginal penetration (84%), vulvovaginal pain and soreness (76%), and vulvovaginal irritation (73%). The symptom most often rated severe was pain with penetration (40%). Vaginal dryness was the symptom reported most frequently (more than four times per week, reported by 53% of participants). Most individuals had told their provider about their symptoms (213/302, 70%) and most (72%) were told to try over-the-counter lubricants or vaginal moisturizers. The two most common reasons for not speaking with a provider about the symptoms were that they were not considered severe (67%) or that patients were not worried about the symptoms (66%). Urinary incontinence (67%) and urinary frequency (43%) also were reported by participants.
COMMENTARY
Many postmenopausal individuals experience symptoms of GSM, which may or may not cause significant bother. Physical exam findings consistent with GSM are vulvovaginal atrophy, vaginal dryness, and introital stenosis.3 The authors of this study sought to describe in detail the type, severity, and frequency of GSM symptoms. This was a secondary analysis of a population they had studied previously in a randomized controlled trial that compared the vaginal estradiol tablet (plus placebo gel), vaginal moisturizer (plus placebo tablet), and dual placebo arms. The randomized controlled trial was published in 2018 and found, interestingly, that neither vaginal estrogen nor vaginal moisturizers were better than placebo tablet or gel in reducing postmenopausal vulvovaginal symptoms.2 Nevertheless, vaginal moisturizers and vaginal estrogen still are the mainstay of treatment for patients who want to pursue active management of bothersome symptoms.
This current study showed that vaginal dryness was the most common symptom of GSM, and pain with vaginal penetration was the most common severe symptom. The study also showed that symptoms did not necessarily occur daily but could be variable and less frequent than daily. Among all patients, the most bothersome symptom regardless of severity was pain with vaginal penetration followed by vaginal dryness. These would be important symptoms to ask patients about, since they are unlikely to improve over time without intervention.
The treatment for GSM symptoms does indeed start with over-the-counter lubricants and vaginal moisturizers. However, vaginal estrogen also is an important treatment option and has been shown to reduce symptoms in other trials.3 This can be in the form of a cream, tablet, vaginal insert, or vaginal ring. A Cochrane review found that all forms of vaginal estrogen were similar and modestly effective in improving symptoms compared to placebo, although the quality of the data was rated as low.4 Other treatment options include a vaginal dehydroepiandrosterone (DHEA) insert (prasterone 6.5 mg daily) that is Food and Drug Administration (FDA)-approved to treat pain with vaginal penetration and ospemifine, a selective estrogen receptor modulator that is FDA-approved to treat vulvovaginal atrophy or GSM.1 Finally, systemic estrogen for vasomotor symptoms also treats GSM symptoms.
REFERENCES
- American College of Obstetricians and Gynecologists. Practice Bulletin Number 141. Management of menopausal symptoms. Published January 2014 (reaffirmed 2021). https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2014/01/management-of-menopausal-symptoms
- Mitchell CM, Reed SD, Diem S, et al. Efficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms: A randomized clinical trial. JAMA Intern Med 2018;178:681-690.
- The NAMS 2020 GSM Position Statement Editorial Panel. The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society. Menopause 2020;27:976-992.
- Lethaby A, Ayeleke RO, Roberts H. Local oestrogen for vaginal atrophy in postmenopausal women. Cochrane Database Syst Rev 2016;2016:CD001500.
