CLINICAL EFFICACY AND SAFETY OF REFORMULATED ACIDOSALUS® VAGINAL PESSARIES COMPARED WITH BIOAPIGYN® PESSARIES IN THE TREATMENT OF VULVOVAGINAL DISORDERS: A RANDOMIZED COMPARATIVE STUDY

Abstract

Vulvovaginal disorders associated with elevated vaginal pH commonly present with vaginal discharge, unpleasant odor, itching, burning, dryness, and dyspareunia. Medical devices acting through physical mechanisms, such as restoration of an acidic vaginal microenvironment and formation of a protective mucosal barrier, represent an important non-pharmacological treatment option. Acidosalus® vaginal pessaries were reformulated by replacing live probiotic bacteria with a non-viable probiotic yeast (Kluyveromyces marxianus fragilis B0399 TN), necessitating renewed clinical evaluation in accordance with Regulation (EU) 2017/745. To evaluate the clinical efficacy and safety of reformulated Acidosalus® pessaries compared with Bioapigyn^® pessaries and to contextualize the results with previously published data on the earlier Acidosalus^® formulation. A prospective, randomized, comparative clinical study was conducted in adult women with nonspecific or mixed vulvovaginal disorders associated with increased vaginal pH. Participants were treated once daily for seven consecutive days with either Acidosalus^® or Bioapigyn^® pessaries. Efficacy outcomes included patient self-assessment of symptoms, investigator assessment, vaginal pH measurement, and evaluation of vaginal purity by native wet mount microscopy. Safety was assessed by monitoring adverse events and local tolerability. Acidosalus® pessaries reduced vaginal discharge by 82.4%, unpleasant odor by 91.7%, itching by 88.9%, burning by 85.7%, and vaginal dryness by 90.0%. Vaginal pH decreased by 12.3%, and normalization of vaginal flora was achieved in 92.5% of patients. Bioapigyn^® pessaries demonstrated comparable efficacy, with symptom reductions ranging from 80.0% to 100%, a 13.0% decrease in vaginal pH, and normalization of vaginal purity in 82.5% of patients. Overall, 85% of participants achieved clinical cure and 15% clinical improvement. No clinical failures or safety concerns were reported. Reformulated Acidosalus^® vaginal pessaries are safe and clinically effective in the treatment of vulvovaginal disorders associated with increased vaginal pH, demonstrating efficacy and safety comparable to an established medical device and consistent with previously reported data, thereby supporting their use in accordance with MDR (EU) 2017/745 requirements.

Keywords

• Acidosalus® pessaries
• Bioapigyn® pessaries
• vulvovaginal disorders
• vaginal pH
• physical mode of action
• medical devices
• clinical efficacy
• safety
• MDR 2017/745

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