biostudies-literatureUnknown12Murina F<h4>Background</h4>The medical literature has reported that recurrent bacterial vaginosis (RBV) has a relapse rate of 35% within 3 months and 60% within 12 months after antibiotic administration. Products that are able to provide a barrier effect against the biofilm produced by Gardnerella vaginalis could play a role in improving the results of bacterial vaginosis (BV) treatment.<h4>Objective</h4>This study aims to assess the performance and safety of a medical device (Polybactum) containing polycarbophil, lauryl glucoside, and glycerides (PLGG) for reducing the rate of recurrence of BV.<h4>Methods</h4>The study includes women who are aged above 18 years, are willing to provide signed informed consent, have a diagnosis of BV according to the Amsel criteria, and have been affected by at leaJMIR research protocolse42787https://www.ebi.ac.uk/biostudies/studies/S-EPMC10401192biostudies-literaturePerformance and Safety of a New Medical Device (Polybactum) for Reducing the Recurrence Rate of Bacterial Vaginosis: Protocol for a Multicenter, Open-Label, Noncontrolled International Clinical Trial (POLARIS Study).PMC10401192Barattini DFArdolino LIBiris MCasolati ESirbu DInghirami PMangrella MRosu SSbrocca FMurina FCrisan CDfalsePerformance and Safety of a New Medical Device (Polybactum) for Reducing the Recurrence Rate of Bacterial Vaginosis: Protocol for a Multicenter, Open-Label, Noncontrolled International Clinical Trial (POLARIS Study).<h4>Background</h4>The medical literature has reported that recurrent bacterial vaginosis (RBV) has a relapse rate of 35% within 3 months and 60% within 12 months after antibiotic administration. Products that are able to provide a barrier effect against the biofilm produced by Gardnerella vaginalis could play a role in improving the results of bacterial vaginosis (BV) treatment.<h4>Objective</h4>This study aims to assess the performance and safety of a medical device (Polybactum) containing polycarbophil, lauryl glucoside, and glycerides (PLGG) for reducing the rate of recurrence of BV.<h4>Methods</h4>The study includes women who are aged above 18 years, are willing to provide signed informed consent, have a diagnosis of BV according to the Amsel criteria, and have been affected by at lea2023-01-01T00:00:00Z2023 Jul2026-05-29T03:51:06.162Z2024-11-06T07:50:43.025ZS-EPMC104011923747111710.2196/42787