Polynucleotides/Sodium Hyaluronate Ovules for Postmenopausal Vulvovaginal Atrophy and Other Vaginal Environment Disorders

Abstract

Introduction: Vulvovaginal atrophy, as the most troublesome symptom complex within the more comprehensive clinical picture of Genitourinary Syndrome of Menopause, severely impacts the postmenopausal women’s quality of life, their self-respect as still attractive women, and possibly the women’s couple relationship. The same may happen at a younger age, with vaginal dryness as an occasional side effect of estro-progestin oral contraceptives, hormone-releasing vaginal rings, and other disorders leading to a deranged vaginal environment. Based on a sound rationale, a new medical device based on natural-origin polynucleotides and sodium hyaluronate formulated as vaginal ovuli may help over the long term with those frequent hassles of middle-aged and younger women. Methods: Design: a survey investigation based on a questionnaire compiled by three investigators familiar with the new vaginal ovuli medical device in their everyday office practice. The investigators completed the survey based on outcomes in 45 ambulatory adult women (≥18 years old). All women had freely consulted the investigators to seek relief from vulvovaginal atrophy symptoms and vaginal dryness as a contraceptive side effect. The minimal inclusion and exclusion criteria helped simulate a real-world office situation. The survey followed a treatment cycle with a Class-III CE-marked medical device (Ovuli PNHA, Mastelli S.r.l., Sanremo, Italy—vaginal ovules with 0.25% polynucleotides, 0.25% non-cross-linked sodium hyaluronate, and 3% polycarbophil as functional ingredients). After the end of the self-administration cycle (one ovule intravaginally per day for two to four weeks), the survey’s goal was to assess the impressions of investigators and their patients about the safety and efficacy (symptom relief, restoration of a healthy vaginal environment) of the medical device in all conditions of vulvovaginal atrophy/vaginal dryness and dystrophic lesions/vaginal environment disorders. The device establishes a protective, moisturizing, and pH-controlled lubricating film onto the cervix and vaginal mucosa and promotes its physiological regenerative and reparative mechanisms. Assessment tools at baseline and after the end of the treatment cycle: Vaginal Health Index score (validated investigator-assessed five-item scale, with scores ranging from 5 to 25 and <15 as dryness and atrophy score threshold); subjective VVA symptom severity (vaginal dryness, vulvovaginal irritation/itching, vulvovaginal soreness, dyspareunia) assessed by the patients with the support of a series of five-point VAS scales (0=absent, 1=mild, 2=moderate, 3=severe, 4 = very severe). Results: The surveyed investigators stated that the mean total VHI score significantly improved over the follow-up period, from 2.5 ± 0.94 to 3.6 ± 0.85 (p <0.001 vs. baseline). The mucosal thickness and integrity, showing severe or very severe atrophy in 13 surveyed women at baseline, presented no more than some mild atrophy in 91.1% of women, with 35.6% of surveyed women reverting to complete restitutio ad integrum. Vaginal dryness also markedly decreased from baseline, with 79% of cohort women improving to mild atrophy or symptom clearance and 21% reverting to restitutio ad integrum. Regarding the subjective symptom relief, the surveyed women reported a highly significant reduction of the mean total VAS score — cumulatively accounting for vaginal itching, vaginal burning, vaginal pain, pain/discomfort during intercourse, and vaginal dryness — from 3.5 ± 0.70 to 2.1 ± 0.73 (p <0.001 vs. baseline). The occasional mild local pain and irritation were of no clinical significance and rapidly transitory. Conclusions: The novel formulation of polynucleotides and sodium hyaluronate as vaginal ovules efficiently counteract the symptom complex due to vulvovaginal atrophy in postmenopausal women, including younger women with contraindications for estrogen therapy and vaginal dryness as a contraceptive side effect. The study confirms that PNs, in synergy with hyaluronic acid, retain their innovative potential as non-pharmacological activators of physiological regenerative and reparative processes in vulvovaginal tissues. The study also confirms the novel device’s safety and the women’s compliance with treatment.