Topical Spermidine Hyaluronate (Spd-HA) in Vulvovaginal Atrophy: A Preliminary Study.

Background and Objectives: Genitourinary syndrome of menopause (GSM), previously termed vulvovaginal atrophy (VVA), is a prevalent hypoestrogenic condition characterized by genital, sexual, and urinary symptoms. Although hormonal therapies are effective, many women are unwilling or unsuitable to use them. Spermidine hyaluronate (Spd-HA) has been reported to be effective in the treatment of vulvodynia and is currently under investigation for stress urinary incontinence. The aim of this study was to evaluate the efficacy of Spd-HA gel on the signs and symptoms of GSM. Materials and Methods: Five postmenopausal women with GSM presenting with vulvovaginal atrophy were enrolled in this prospective, single-arm, pilot study. They applied Spd-HA gel locally for eight weeks (three times/week for the first 4 weeks, followed by two times/week for the next 4 weeks). Vulvovaginal signs and symptoms were assessed at baseline (V1), 4 weeks (V2), and 8 weeks (V3) using the most bothersome symptoms (MBS), vaginal health index (VHI), and maturation index (MI) and value (MV). Results: Spd-HA gel was associated with MBS score improvement from baseline to week 8 [from (5.00 ± 2.00) to (1.60 ± 1.52)]. VHI score and MI improved from baseline to week 8. Compared to literature data, improvement in MVs obtained in women who received Spd-HA was greater than those obtained by hydrating products, but lower than those observed in women with estrogen or prasterone therapy. Conclusions: This preliminary experience suggests that Spd-HA gel ameliorates the vulvovaginal component of GSM. It may represent a promising non-hormonal option for women with GSM who are unwilling or unsuitable to receive hormonal therapy, warranting confirmation in larger controlled trials.