Vabip (Vaginal Biorevitalization With Polydeoxyribonucleotides) Randomized Controlled Trial for the Genitourinary Syndrome of Menopause

Abstract

Objective: This study compares the clinical improvement of genitourinary syndrome of menopause (GSM) and the capacity of vaginal biorevitalization between the gold standard treatment based on local hormonal therapy with estrogens (ES-based therapy) versus local therapy based on salmon polydeoxyribonucleotides (PDRNs-based therapy). Study design: Double blinded randomized clinical trial. The colposcopist and pathologist were blinded about which patient received one treatment or another. We randomly assigned 106 postmenopausal women (aged 38-77) with GSM. The control group (n=49) received ES-based therapy with bovine estrogen cream three times weekly. The treatment group (n=57) received vaginal suppositories from PDRNs only for six days every night during the first week. Main outcome measures: the severity of sexual and urinary problems, and the vaginal dryness using the Menopause Rating Scale (MRS). Moreover, alteration in vaginal pH and the atrophy of vaginal epithelium. Results: At 3 months of follow-up, the PDRNs-based therapy group presented a significantly decreased in the probability of presenting moderate-to-severe symptoms for sexual problems (OR= 0.07, CI 0.16-0.33, p<0.001), urinary problems (OR= 0.10, CI 002-0.50, p=0.004), vaginal dryness (OR= 0.17, CI 0.03-0.84, p=0.03), altered vaginal pH (pH>5) (OR= 0.20, CI 0.0.09-0.47, p<0.001) and atrophy of vaginal epithelium (OR= 0.02 CI 0.006-0.09, p<0.001) compared with the ES group. We also found a significant augmentation of intermediate cells in PDRNs-treated group (p=0.001). Conclusion: Our data suggest that PDRNs-based local therapy can biorevitalize the vagina and improve GSM in a clinically significant manner compared to the gold standard treatment with ES-based therapy (NCT05464654).