Efficacy and safety of a novel vaginal medical device in recurrent bacterial vaginosis: a multicenter clinical trial.

Abstract

Background: The effectiveness of a new vaginal medical device, which contains polycarbophil, 0.04% lauryl glucoside and glycerides (Polybactum^®, Effik Italia Spa, Cinisello Balsamo, Milan, Italy), in reducing BV recurrence rate was investigated.

Methods: This was a multicenter, open label, not comparative study. Women over 18 years old affected by recurrent BV were included. The latest episode was diagnosed by Amsel criteria 6-9 days before the start of the study and treated with vaginal metronidazole (gel 0.75% mg for 5 days or ovules 500 mg for 7 days). The recurrence was defined by at least 2 episodes in the previous 12 months. Polybactum^® vaginal ovules, day 1-4-7, were started within the 12^th and the 24^th hour after the end of metronidazole therapy and repeated monthly for 3 cycles.

Results: The first 41 patients enrolled were evaluated for an interim analysis 6 months after the study started; 2 patients interrupted the trial, leaving 39 evaluable subjects. The recurrence rate was significantly reduced compared to previous published data (10.26% vs. 40% P<0.001). In 35 patients without recurrence, the assessment of Lactobacillus vaginal flora performed by phase contrast microscopy evidenced a significant improvement form baseline (P=0.022) The investigator global assessment of tolerability was excellent in 38 out of 39 cases.

Conclusions: Our research showed that 3 monthly cycles of Polybactum^® ovules administered after one course of metronidazole vaginal therapy can reduce the rate of Bacterial vaginosis recurrence and improve the vaginal milieu, favoring the growth of vaginal lactobacillus species.