Genitourinary syndrome of menopause (GSM) refers to a wide range of symptoms and conditions associated with changes in the genital and urinary systems due to the decline in estrogen levels during menopause. As estrogen production decreases, structural and functional changes occur in the tissues of the vagina, vulva, bladder, and urethra, leading to a variety of genital and urinary symptoms. Formerly known as vulvovaginal atrophy, the term genitourinary syndrome of menopause more accurately reflects the broad range of changes affecting both the genital and lower urinary tracts during the menopausal transition.
The symptoms can include vaginal dryness, irritation, burning, painful intercourse (dyspareunia), recurrent urinary tract infections, and urinary incontinence and they have a significant impact on quality of life. Despite these symptoms, more than 50% of affected patients are not using any treatments to alleviate their discomfort.
A distinctive feature of GSM is that the condition is progressive, and the symptoms often do not diminish over time, but they worsen over time without treatment. Various treatment options, ranging from nonhormonal lubricants and moisturizers to hormone replacement therapy, are available to alleviate symptoms and improve quality of life.
The primary cause of genitourinary syndrome of menopause is the decreased estrogen levels in postmenopausal individuals or in those of any age who experience reduced estrogenic stimulation of the urogenital tissues.
The menopausal transition is an important moment in the aging of the genital tract. Cyclic, higher levels of estradiol in premenopausal change to varying levels in perimenopause and even lower levels in postmenopause. In cross-sectional studies, low estradiol levels are associated with a higher prevalence of vaginal dryness symptoms. However, the longitudinal relationships between the stages of menopausal transition, reproductive hormone changes, the development of vaginal dryness, and the potential sexual consequences of this symptom have not been well studied.
The prevalence of vaginal dryness increases in the years following menopause and causes disturbing symptoms such as itching, burning and/or pain during intercourse, which contributes to the decline of libido.
Vaginal dryness, a symptom of menopausal genito-urinary syndrome, increases with age and the progression of the menopausal stage. It can be caused by reduced secretory function of the vaginal epithelium, which is associated with decreased vaginal blood flow, mucosal thinning, changes in microbiomes, and inflammation. Women may report vaginal dryness as irritation, itching, or burning outside of sexual activity.
Menopause causes a dramatic 95% reduction in estrogen production, resulting in 75% of women experiencing vaginal dryness, 40% reporting pain during intercourse, and 30% to 40% experiencing urinary urgency and frequency.
When estrogen level decline, the vaginal epithelium becomes atrophic with reduced secretions and a less acidic environment characterized by a pH greater than 5, and frequent urinary tract infections and discomfort during sexual activity occur.
GSM can be managed with various treatment modalities aimed at alleviating symptoms. These treatments are generally classified into nonhormonal and hormonal options.
Nonhormonal treatments such as vaginal and topical moisturizers and lubricants are considered the first-line therapy for GSM. Lubricants provide short-term relief, particularly for vaginal dryness during intercourse, while moisturizers offer longer-lasting effects and can be used daily or several times per week.
Systematic efficacy and safety reviews of hormonal treatment (vaginal oestrogen products) for moderate-to-severe GSM have reported it to be superior to placebo in achieving subjective improvement in vaginal dryness, dyspareunia, and urogenital symptoms.
Conventional treatment for postmenopausal syndrome, in terms of systemic and genital symptoms, is based on hormone replacement therapy (TSH). The limitations of this approach are represented by the need to stop treatment after a while and the contraindications for some women. Topical application of hyaluronic acid to control the symptoms of vulvovaginal atrophy in postmenopausal women has been shown to be significantly effective in terms of both objective and subjective improvement.
Hyaluronic acid is naturally present in many parts of the body, including the urinary and genital tissues, where it maintains adequate levels of hydration, thus promoting tissue elasticity and alleviating vaginal dryness.
Halova ovules are an excellent option for patients who have contraindications to estrogen therapy or choose not to use estrogen.
Currently, estrogen therapy, approved for the treatment of vaginal atrophy, is often associated with adverse effects and multiple contraindications in menopausal patients. Among them, metabolic imbalances, mood changes, bloating, as well as the risk of developing ovarian cancer are the most common. Moreover, long-term use of estrogen therapy can lead to breast cancer and should therefore be limited.
Thus, there was a need to develop new alternative preparations that would provide therapeutic benefits and successfully replace estrogen therapy. One such strategy is the use of topical lubricants.
Currently, estrogen therapy, approved for the treatment of vaginal atrophy, is often associated with adverse effects and multiple contraindications in menopausal patients. Among them, metabolic imbalances, mood changes, bloating, as well as the risk of developing ovarian cancer are the most common. Moreover, long-term use of estrogen therapy can lead to breast cancer and should therefore be limited.
Thus, there was a need to develop new alternative preparations that would provide therapeutic benefits and successfully replace estrogen therapy. One such strategy is the use of topical lubricants. But not all topical lubricants are the same.