Efficacy and safety of a novel vaginal medical device in recurrent bacterial vaginosis: an international multicentre clinical trial

Abstract

14Several risk factors have been identified but the etiology and pathogenesis of Bacterial 15 vaginosis (BV) are still not completely understood, and the recurrence rate of BV remains 16 high despite adequate chemotherapy treatment. 17 The primary objective of the study was to assess the effectiveness of a new vaginal 18 medical device, which contains polycarbophil, 0.04 % lauryl glucoside, and glycerides 19 (Polybactum ® -Effik Italia), in reducing BV recurrence rate. 20 This was a multicenter, open label, not comparative study performed in Italy and Romania. 21 Female subjects over 18-years-old affected by recurrent BV were included. The latest 22 episode was diagnosed by Amsel criteria 6-9 days before the start of the study and treated 23 with vaginal metronidazole (gel 0.75% mg for 5 days or ovules 500 mg for 7 days). The 24 recurrence was defined by at least 2 episodes in the previous 12 months. Polybactum ® 25 vaginal ovules, day 1-4-7, were started within the 12th and the 24th hr after the end of 26 metronidazole therapy and repeated monthly for 3 cycles. 27 The first 41 patients enrolled were evaluated for an interim analysis 6 months after the 28 study started; 2 patients interrupted the trial, leaving 39 evaluable subjects. The 29 recurrence rate was significantly reduced compared to previous published data (10.26% vs 30 40% p<0.001). In 35 patients without recurrence, the assessment of Lactobacillus vaginal 31 flora performed by phase contrast microscopy evidenced a significant improvement form 32 baseline (p=0.022) The Investigator global assessment of tolerability was excellent in 38 33 out of 39 cases. 34 IMPORTANCE 35 Bacterial vaginosis (BV) is the most common vaginal disorder in women of childbearing 36 age. In BV, Lactobacillus species, which are predominant in a healthy vaginal flora, are 37 replaced by anaerobes, mainly Gardnerella vaginalis. BV is responsible for more than 60% 38 of vulvovaginal infections and has been linked to serious, potentially life-threatening 39 3 conditions, including: pelvic inflammatory disease, postoperative infections, acquisition and 40transmission of the human immunodeficiency virus, preterm birth, and several adverse 41 pregnancy outcomes. Our research showed that 3 monthly cycles of Polybactum ® ovules 42 administered after one course of metronidazole vaginal therapy can reduce the rate of 43 Bacterial vaginosis recurrence and improve the vaginal milieu, favouring the growth of 44 vaginal lactobacillus species. Taken together our results confirm that Polibactum ® is a 45 safe and effective treatment to reduce BV recurrence rate after a first line therapy with 46 metronidazole. 47 48 49 Bacterial vaginosis (BV) is the most common vaginal disorder in women of childbearing 50 age (1). In BV, Lactobacillus species, which are predominant in a healthy vaginal flora, are 51 replaced by anaerobes, mainly Gardnerella vaginalis, but also Atopobium vaginae, 52 Mobiluncus mulieris, Prevotella bivia, and Fusobacterium nucleatum. 53 BV is responsible for more...