POLARIS (Polybactum® to Assess Recurrent Bacterial Vaginosis): Open-label, Non-controlled, International Clinical Study with Extended 10-month Follow-up without Treatment
التفاصيل البيبلوغرافية
العنوان:
POLARIS (Polybactum® to Assess Recurrent Bacterial Vaginosis): Open-label, Non-controlled, International Clinical Study with Extended 10-month Follow-up without Treatment
Recurrent bacterial vaginosis (RBV) after antibiotic treatments has a relapse rate of 35% within 3 months and 60% within 12 months. Products containing polycarbophil (PLGG), that inhibits bacterial growth and mucoadhesive property, can impair biofilm formation. Here are shown the results of the POLARIS (Polybactum® to assess Recurrent Bacterial Vaginosis) study. The first phase was an interventional, open-label, non-controlled, and multicentre trial enrolling 56 women in Italy and Romania. The second phase was an observational 10-month follow-up without treatment conducted only in Romania. After 3 cycles with PLGG, only 8 BV recurrences out of 54 evaluable patients were identified (rate 14.81%) and for 26 out of 39 patients (66.67%) was evidenced positive effect on Lactobacilli in the vaginal secretions. In the follow-up 35 patients were observed after PLGG stopping treatment; 1 RBV (2.86%) at the 4th month and an additional 6 cases (17.14%) were evidenced at the end of the follow-up period. Therefore, no recurrence was evidenced in 12 subjects (34.28%) at 10th ± 2 months after the end of the PLGGtreatment. The use of PLGG vaginal ovules in the treatment of BV reduces the rate of relapses and improves the microbiological parameters (positive effect on Lactobacilli in 66.7 % of cases).