Bacterial vaginosis is the most common vaginal infection in reproductive-age women1. Sufferers have access to multiple treatments but the high rate of recurrence and patient-to-patient variability in the effectiveness of existing products points to the need for additional options.
The need for new treatment options for women with bacterial vaginosis is evident in data on the prevalence, outcomes and impact of the condition. Almost 25% of women aged 15 to 49 years in Europe have bacterial vaginosis.2 France, Germany, Italy, Spain and the UK are home to 67.5 million reproductive-age women, suggesting there are around 16 million women with bacterial vaginosis in the biggest European markets.3
Fungal infection of the vulva and the vagina is estimated to be the second most common cause of infection after bacterial vaginosis4. About 75% of women during their reproductive age have at least one episode of vulvovaginal candidiasis (VVC)5 and approximately half of them have two or more episodes. The most common pathogen is Candida albicans, which is isolated in 85% to 90% of all cases6.
International Health Science approached the development of a bacterial vaginosis product armed with an understanding of the markers of good vaginal health and the drivers of the condition. That understanding enabled IHS to identify the key functional ingredients needed for an effective treatment. IHS has responded to that need by developing a complete range for vaginal health, named RESPECTA: medical devices available for out-licensing under private label that addresses the core elements of vaginal health.
The RESPECTA line consists of three products: RESPECTA capsules, RESPECTA Balance Gel and RESPECTA Hydra Gel.
RESPECTA oral capsules is a clinically proven medical device recommended for the treatment of vaginitis and vaginosis and for restoring the balance of vaginal flora.
RESPECTA Balance Gel is a medical device adjuvant in the treatment of vaginitis and vaginosis specifically studied for rebalancing the physiological pH and vaginal microbiota.
RESPECTA Hydra Gel is a medical device with moisturising and lubricant action recommended for the treatment and prevention of vaginal dryness.
In particular, RESPECTA capsules acts on the vaginal microbial ecosystem thanks to the clinically proven ability of its probiotic strains to migrate from the intestinal lumen to the female genital apparatus. The product works in three ways:
1. Adheres to the epithelium of the vaginal mucosa resulting in a barrier effect.
2. Contrasts the attack of pathogenic bacteria and prevent their adhesion to the vaginal mucosa.
3. Protects against the infection creating a hostile environment for proliferation of opportunistic microorganisms through the production of lactic acid which maintains a healthy vaginal pH.
The functional substances contained inside them are Lactobacillus acidophilus LMG S-29159, Lactobacillus rhamnosus ATCC SD5675 and Lactoferrin RCX have been proven to act synergistically to restore and maintain healthy vaginal flora and promote genitourinary tract health.
Study description
International Health Science validated the efficacy of RESPECTA Balance Gel in an in vitro study that built on the positive findings of earlier clinical trials with the oral formulation (RESPECTA capsules). The in vitro study showed the medical device does not negatively affect the lactobacilli associated with good vaginal health. There was no dysbiosis or negative changes in the balance of the vaginal microbiome after treatment.
Rather, RESPECTA Balance Gel supported the proliferation of friendly bacteria. Lactobacilli were found on the tissue surface in large numbers in their active replicative phase, leading the researchers to conclude overnight treatment with RESPECTA Balance Gel boosts colonisation by the key bacteria.
Conclusion
Lactobacilli, the predominant bacteria in a healthy vaginal flora, play a key role in defending against urogenital infections. When the level of lactobacilli is disrupted and the vaginal flora becomes imbalanced, the risk of developing an infection may increase. Vaginal complaints such as itching, burning and discharge, can be signs of a bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC), the two most common reasons women visit their healthcare providers and need such a product. By working with IHS, private label distributors can address the needs of those women through the commercialisation of a safe, reliable and proven medical devices.
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1 Kairys, N. & Garg, M. Bacterial Vaginosis. in StatPearls (StatPearls Publishing, 2020).
2 Peebles, K., Velloza, J., Balkus, J. E., McClelland, R. S. & Barnabas, R. V. High Global Burden and Costs of Bacterial Vaginosis: A Systematic Review and Meta-Analysis. Sex. Transm. Dis. 46, 304–311 (2019).
3 Women of reproductive age (15-49 years) population (thousands). https://www.who.int/data/maternalnewborn-child-adolescent-ageing/indicator-explorer-new/mca/women-of-reproductive-age-(15-49-years)-population-(thousands) .
4 Dovnik A, Golle A, Novak D, Arko D, Takač I. Treatment of vulvovaginal candidiasis: a review of the literature. Acta Dermatovenerol Alp Pannonica Adriat. 2015;24(1):5‐7.
5 van Schalkwyk J, Yudin MH, Yudin MH, et al. Vulvovaginitis: screening for and management of trichomoniasis, vulvovaginal candidiasis, and bacterial vaginosis. J Obstet Gynaecol Can. 2015;37(3):266‐274.
6Linhares IM, Witkin SS, Miranda SD, et al. Differentiation between women with vulvovaginal symptoms who are positive or negative for Candida species by culture. Infect Dis Obstet Gynecol. 2001;9(4):221‐225.
