For healthcare

About bacterial vaginosis – for health care

Bacterial vaginosis (BV) is the most common vaginal infection among women of reproductive age, with a prevalence of about 30% worldwide1. Risk factors include unprotected intercourse, new partners, and excessive hygiene. For many, each menstruation poses a risk for developing bacterial vaginosis.

The microbiota of a healthy vagina consists of mainly lactobacilli, that are natural producers of lactate and hydrogen peroxide. These two components constitute a defense against vaginal infections. BV occurs under conditions when harmful, predominantly anaerobic bacteria such as Gardnerella vaginalis becomes predominant in the vaginal milieu, undermining the protective lactobacilli that normally colonize the vagina. 

The most common symptom of bacterial vaginosis is a malodorous discharge, itching and burning may also occur. The smell, resembling that of fish, stems from the release of amines. Symptoms may be exacerbated in association with raised pH level, occurring during menstruation or unprotected intercourse. Symptoms may therefor vary over time.

Apart from the characteristic fishy odor the discharge may be thin, with a colour range from yellow to grey. The symptoms can be very unpleasant and result in negative psychological impact on the self-esteem, impacting the desire to engage in close association, intimately and socially with other persons.  It is important to note that approximately 50% of all women with BV have no symptoms.

Bacterial vaginosis is linked to increased risk of acquiring sexually transmitted diseases such as gonorrhea, chlamydia, HPV, and HIV. Untreated BV is linked to increased risk of serious complications such as PID (Pelvic Inflammatory Disorder) and, during pregnancy, increased risk of miscarriage, premature birth, and low birth weight2.

The diagnosis is made by gynaecological examination and traditionally requires at least three out of four Amsel criteria to be fulfilled:

  • Thin, homogenous, greyish-yellow, often frothy vaginal discharge.
  • Vaginal fluid pH > 4.5.
  • Positive potassium hydroxide test (‘sniff’ or ‘whiff’ test) – pH increase causes characteristic fishy smell bacterial release of amines
  • Presence of clue cells on wet mount – epithelial cells with large amounts of adherent bacteria visible in the

    smear when examined under a microscope (see image at the top of this page).

Today, there are also PCR tests available for purchase directly from pharmacies or via certain health care facilities.

The current standard treatment of bacterial vaginosis is local or oral antibiotics or antiseptics, however more than half of the treated patients experiences recurrent bacterial vaginosis within a year following the treatment3.

Since antibiotics also wipe out the normal bacterial flora of the vagina – the lactate-producing lactobacilli – the woman is at risk of developing an antibiotic-induced fungal infection (vulvovaginal candidiasis) in addition to the bacterial vaginosis. This, of course, causes even more suffering and leads to a need for additional treatments. There is a risk of sliding into a spiral of suffering and treatment.

Apart from the undesirable side effects of antibiotic treatment, the increased use of antibiotics in our society today, has caused a rapid increase in bacteria that develop antibiotic resistance, something that health organizations classify as a global health threat.

Antibiotic-free treatment of bacterial vaginosis – available over the counter!

Antibiotic-free treatment of bacterial vaginosis – available over the counter!

Vernivia is a CE-marked medical device intended for local treatment of bacterial vaginosis. This treatment is an effective non-prescription local therapy in the form of a vaginal mousse, without supplements such as antibiotics, parabens, and perfume. The vaginal mousse is applicated in the vagina at bedtime, and once the dose is administered the mousse instantly spreads across the entire surface of the vagina, reaching all folds and crevices. The unique technology enables the treatment to reach, cover and treat all infected areas of the mucous membrane in the vagina. The vaginal mousse covers the vaginal wall and treats the entire infected area every time it is applied. The video below demonstrates the good adhesive properties of Vernivia.

Vernivia vaginal mousse contains:

  • Monoglycerides with general antimicrobial and anti-mycotic properties antimicrobial and anti-mycotic effect
  • The stabilizer hydrogen peroxide, which promotes the regrowth of bacteria that produce lactic acid and has a general antimicrobial effect

  • Lactic acid, which restores the pH and possesses antimicrobial properties

Vernivia inhibits harmful bacteria, stimulates the growth of naturally occurring lactic acid-producing lactobacilli, and thus helps restore the vagina’s own defenses.

Vernivia vaginal mousse is applied in the vagina at bedtime for seven consecutive days.

Vernivia vaginal mousse is applied in the vagina at bedtime for seven consecutive days.

Our instructional film

Clinical trial

A clinical proof-of-concept study forms the foundation for the authorization and CE certification of Pharmiva’s first product Vernivia. The study was conducted on women with a bacterial vaginosis diagnosis. Results showed that Vernivia treatment helped to increase the number of lactobacilli and re-established a natural bacterial flora in the vagina. Vernivia demonstrated a cure rate that is comparable with local antibiotic treatment, in addition, the relief from experienced symptoms was superior to that of antibiotics5.

These clinical results confirm that Vernivia has the potential to become an effective alternative over-the-counter treatment for bacterial vaginosis.

User study

In collaboration with gynecological clinics and midwifery clinics in Sweden, a user study, classified under MDR as a PMCF, Post Market Clinical Follow-up study, was conducted during the spring of 2021. To be included in the study, patients had to exhibit  clinical symptoms of bacterial vaginosis.

The purpose of this study was primarily to evaluate Vernivias efficiency to relief symptoms during the treatment and to evaluate how users perceived the product . Our goal was to create the best possible conditions for an introduction of the product to the Swedish pharmacy market and to provide a basis for training and product awareness among healthcare providers and patients.

introduction on the Swedish pharmacy market and to provide a basis for training and product awareness among healthcare providers and patients.

In total, 76 patients, from seven clinics in Sweden, all with symptomatic bacterial vaginosis were included in the study. Patients were treated with one dose of Vernivia prior to bedtime every night for one week. Surveys were conducted where the patients answered questions regarding their symptoms (abnormal discharge and odor) before, during, and immediately after the treatment. In addition, patients were asked to assess the usability and their overall impression of the product.

Patients reported   significant improvement for both odor and the amount of discharge within 12 hours after the first dose. These effects continued to amplify over the course of the treatment.  Patients also found the usability of Vernivia as very high. After completing the study, 74% of the patients described the treatment as “good” or “very good”, and 79% indicated that if bacterial vaginosis reoccurred, they would use Vernivia as treatment. Additionally, 83% of the women responded that they would recommend the product to a friend.

as amplified over the course of the treatment. The reported usability was also very high. Upon completion of the study, 74% of patients described the treatment as ‘good’ or ‘very good’, and 79% indicated that they would use Vernivia again should the need arise. Of the patients, 83% responded that they would recommend the product to a friend.

What is a microbiota?

Inside our bodies are a 100 trillion microbes. A myriad of bacteria, that are essential for our good health. Microbes reside throughout your body with the majority being found in the gut. Even the vagina has a microenvironment of its own. The balance between the microbiota and your body is essential to preserve and you can nourish the microbiome through proper nutrition and treatments. However, if the balance is shifted, we may become ill. The bacterial balance can also be altered through antibiotic treatments, that apart from treating the harmful bacteria also disturbs the beneficial microbiome.  It is therefore that antibiotics are only used when there are no other options available. This is to preserve the body’s own microbiota and health, but also to reduce the impact on the increasing development of antibiotic resistance. More information can be found here:

 https://www.who.int/health-topics/antimicrobial-resistance and https://www.folkhalsomyndigheten.se/smittskydd-beredskap/antibiotika-och-antibiotikaresistens/

What is the vaginal microbiota?

The vaginal microbiota is a subset of the human microbiota. The unique feature of the vaginal microbiota is that it is dominated by relatively few species of “good bacteria”, which together maintain and manage the vaginal balance. This provides the foundation for what we call “the vagina’s natural defenses.” The vaginal microbiota begins to develop immediately when a girl is born, within the first 24 hours, and by the time she gets her first menstruation it already resembles the bacterial composition of an adult woman.

The most common bacteria belong to the lactobacilli family. The lactobacilli are in turn partly controlled by the woman’s oestrogen levels. Genetics also play a role in the composition of the vaginal microbiota and therefore varies slightly between women in different parts of the world. Lactobacilli belong to the so-called fermentative bacteria. They produce lactic acid, which reduces the pH level of the vaginal tract and contributes to the acidic environment in the vagina. In this manner, the lactobacilli maintain the natural pH balance of the vagina. A normal vaginal pH range between 3.8 to 4.2.

In addition to lactic acid, lactobacilli produce small amounts of hydrogen peroxide (H2O2), which together with the lactic acid, play an important role in the natural defense against infection. Hydrogen peroxide has a strong inhibitive effect on harmful bacteria. It is when the balance between the beneficial bacteria in the vagina and other bacteria, harmful bacteria, is disturbed that a dysbiosis (imbalance) occurs. This imbalance could lead to infections such as bacterial vaginosis. I nfections such as bacterial vaginosis reduce the body’s defenses against other infections, such as HIV, gonorrhea, and chlamydia.

What influences the vaginal microbiota, and how does it evolve over the menstrual cycle and life of a woman?

The vaginal microbiota can be affected by internal and external factors. External factors include excessive intimate hygiene and unprotected vaginal sex. Contraceptives such as IUDs and hormonal contraceptives may also have an impact on the vaginal balance, as well as other hormonal treatments. If the microbial balance is disrupted, the imbalance can cause infections such as bacterial vaginosis.

One of the most important internal factors that influence the vaginal microbiota are the natural hormones that circulates the body. As mentioned previously, lactobacilli are the most common species in the healthy vaginal microflora. These bacteria are strongly affected by the woman’s oestrogen levels.

Among the most important internal factors that affect the vaginal microbiota, and the vaginal balance, are the hormones of the body. As mentioned above, the most common beneficial bacteria in the vagina belong to the lactobacilli family, and these are controlled, among other things, by the oestrogen levels which vary throughout the menstrual cycle. This in turn impacts the lactobacilli which have been shown to decrease in number during the first days of the menstrual cycle, and at the same time the vaginal pH has been observed to increase during this period.

During pregnancy, oestrogen levels rise which directly affects the epithelial cells and the environment in the vagina. The growth of lactobacilli increases, further strengthening and stabilizing the natural defenses of the vagina.

At menopause, however, the oestrogen levels decrease, this affects the vaginal environment and could make the mucous membranes thinner and more vulnerable while reducing the amounts of lactobacilli.

Is there a need for more research in this area?

It is known that the vaginal microbiota is constantly evolving during a woman’s life, from birth, via menstruation, to menopause. However, more research in this exciting area is needed. Studies that investigate how the vaginal defense – the vaginal microbiota – can best be stimulated and maintained. Moreover, many women are affected by imbalances in the vaginal environment   during menstruation, when the pH level of the vagina increases, and in some cases, this may lead to lasting imbalance in the vagina that could result in infections such as bacterial vaginosis. Read more about bacterial vaginosis.

References

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