Novel Medical Tool Demonstrates Efficacy in Reducing Recurrence Rates of Bacterial Vaginosis

The most prevalent vaginal infection in women of childbearing age is bacterial vaginosis (BV). Beyond 60% of all vulvovaginal diseases are caused by BV.



Bacterial vaginosis may also lead to other high-mortality illnesses such as HIV, PID, and bad pregnancy outcomes. Several acids predominate in a healthy vaginal lining, acting as a protective surfactant layer. This vaginal structure creates an acidic environment that prevents bacteria and other microbes from growing. During BV development, the physiological vaginal microbiota changes, producing a reduction of acidic species and an increase of different harmful bacteria, mainly anaerobic bacteria. Approximately half of BV patients are asymptomatic. A proper diagnosis of BV requires meeting three of four Amsel standard criteria.

Several oral and topical drugs can assist with the first treatment. However, the cause and transmission of BV remain unknown. This lack of understanding has resulted in inefficient BV treatment, with high recurrence rates. According to research, more than half of women will have a recurrence within a year.

The current study aimed to check the efficacy of a novel vaginal device called Polybactum in reducing the number of BV recurrences.

Polybactum is the way

The study location was Italy and Romania. Study participants were females over 18 years affected by repeat BV. A total of 39 females participated in the research. The diagnosis was confirmed using the Amsel criteria a few days prior.

The involvement in the study was by a recurrence rate of two episodes of BV in the previous twelve months. Polybactum® ovules were administered intravaginally in three treatment cycles ranging from 72 to 84 days.

The study was to detect the recurrence of BV using the diagnostic criteria. The participants underwent assessment at the baseline and final visits. Meeting three of the four Amsel criteria was required for the positive detection of BV. If two or fewer conditions were present, BV was ruled out. If the individuals met two diagnostic criteria at the final appointment, they were considered a “treatment failure.”

The researchers analyzed their primary objective with the treatment outcome. Four cases of a repeat BV were noted at the final visit. Therefore, the scientists report a recurrence ratio of BV following three months of treatment using Polybactum at 10.26%. This result is significantly different and better when compared to the value of the recurrence ratio figure, placed at 40% in the medical literature.

Clinical significance

The high prevalence of BV presents a need to develop an effective product to treat the condition and prevent its reoccurrence. The new study showed a significantly lower recurrence rate using Polybactum as the treatment approach. Thus, Polybactum may be a novel clinical approach to treating BV.


This study strengthens evidence on the use of specific novel vaginal products with well-demonstrated efficacy that hinders the persistent recurrence rates of vaginal infections caused by bacterial vaginosis. One or two more similar studies might be needed to serve as confirmation.


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



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