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ORIGINAL ARTICLE   Free accessfree

Minerva Ginecologica 2020 October;72(5):292-8

DOI: 10.23736/S0026-4784.20.04661-4


lingua: Inglese

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

Filippo MURINA 1 , Ciprian CRIȘAN 2, Marius BIRIȘ 2, Daniela SÎRBU 2, Dionisio F. BARATTINI 3, Luca I. ARDOLINO 4, Elena CASOLATI 5

1 Unit of Lower Genital Tract Disease, Vittore Buzzi Hospital, University of Milan, Milan, Italy; 2 Clinica Medicală, Timisoara, Romania; 3 Opera CRO, TIGERMED Group Company, Timisoara, Romania; 4 Effik Italia Spa, Cinisello Balsamo, Milan, Italy; 5 Private Practitioner of Obstetrics and Gynecology, Milan, Italy

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 12th and the 24th 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.

KEY WORDS: Vaginosis, bacterial; Biofilms; Calcium polycarbophil; Vaginitis

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