Nearly a year after the Food and Drug Administration (FDA) announced hormone therapy label changes, Azure Med Spa explains their relevance to genitourinary syndrome of menopause (GSM). GSM can involve bladder leakage, as can urinary incontinence after childbirth, though the causes may differ. The practice is clarifying the distinction between local and systemic therapy when evaluating menopause-related symptoms.

GSM affects genital and urinary tissues, so its symptoms can seem unrelated. Urinary symptoms can include urgency, frequent urination, painful urination, leakage, and recurrent urinary tract infections. Genital symptoms can include dryness and burning, along with discomfort during sexual activity.

The FDA announced plans on November 10, 2025, to revise boxed warnings on menopausal hormone therapy products. It approved the first six revised labels in February 2026, removing cardiovascular disease and breast cancer risk statements from those products' boxed warnings. However, the endometrial cancer boxed warning remains on systemic estrogen-alone products.

On October 30, 2026, the FDA approved revised labeling for three additional hormone therapy products, all estradiol patches. The agency’s requested revisions retain cardiovascular disease and breast cancer warnings elsewhere in systemic product labeling. The changes therefore concern how risks are communicated, rather than establishing that every hormone treatment is appropriate for every patient.

Systemic estrogen is used to treat hot flashes and other menopause-related symptoms. According to Cedars-Sinai, low-dose vaginal estrogen products have very low absorption into the bloodstream, and the original warning did not separate them from systemic therapy. The Medical Letter describes low-dose vaginal estrogen as preferred for GSM in women without significant hot flashes.

In a 2025 Urology survey, 38.4% of the 323 women prescribed vaginal estrogen reported not using it because they feared side effects. Experts had asked the agency to reconsider the labels, arguing that they overstated risk and deterred appropriate use.

The American Urological Association (AUA) released a guideline on genitourinary syndrome of menopause on April 28, 2025, with 26 recommendations covering evaluation and treatment. Its recommendations emphasize shared decision-making based on evidence and patient preferences. Clinicians should also assess for coexisting genitourinary conditions, making symptom evaluation important before attributing urinary problems to GSM.

Among its recommendations, clinicians should screen patients with a focused history and perform a genitourinary examination. Clinicians may also refer patients with GSM and pelvic floor dysfunction to a physical therapist who specializes in pelvic floor conditions. The Agency for Healthcare Research and Quality notes that the guideline also covers breast cancer survivors and stresses multidisciplinary care.

The guideline states that clinicians may offer local low-dose vaginal estrogen to patients with GSM and conditions such as overactive bladder. It also supports recommending low-dose vaginal estrogen to reduce future urinary tract infections in patients with GSM and recurrent infections. Whether any therapy for GSM is appropriate depends on medical history.

For incontinence care, Azure Med Spa begins each visit with a consultation to review medical history and discuss symptoms and goals. Persistent urinary or genital symptoms after menopause warrant evaluation since untreated genitourinary syndrome of menopause tends to worsen over time.

Azure Med Spa is based in Frisco, Texas, and serves patients across North Texas with aesthetic and gynecologic services. Henry Ramirez, MD, FACOG, is an OB/GYN and aesthetic surgeon at the practice. The practice also offers bioidentical hormone replacement therapy, which is prescribed based on individual hormone levels and symptoms and managed by a licensed provider.

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For more information about Azure Med Spa, contact the company here:

Azure Med Spa
Dr Henry Ramirez
+19722946992
info@azurefrisco.com
2840 Legacy Dr Ste 200, Frisco, TX 75034, United States