ABSTRACT:

Objective: Bacterial vaginosis (BV) remains a significant challenge in menopausal women, where physiological changes from the genitourinary syndrome of menopause (GSM) result in an increased vaginal p Hand shifts in the vaginal microbiota. Recent studies reveal BV prevalence rates ranging between 2%-57% among postmenopausal women, often complicated by diagnostic challenges due to the physiological changes of menopause and the similarity with BV symptoms. Traditional diagnostic methods for BV may be inadequate to determine BV prevalence in this group, as most were validated predominantly in premenopausal populations. Current data suggest significant differences in the vaginal microbiota of postmenopausal women compared to their premenopausal counterparts, which may influence disease presentation and management. The ability to manage vaginal pH is particularly critical in this demographic, as elevated pH is a risk factor for the development of BV as well as the acquisition of other vaginal infections.

Design: We conducted three longitudinal pilot studies enrolling pre- and post-menopausal women aged 17-68 with recurrent BV following their use of a novel vaginal hygiene system comprising a vulvar wash, avaginal lactic acid gel, and a probiotic suppository over periods of 11 to 24 weeks. Assessments included changes in vaginal pH, BV recurrence rates determined through clinical and microbiome testing, Nugent scores, and self-reported symptoms.

Results: The intervention led to a statistically significant reduction in vaginal pH across all studies. Vaginal pH was assessed at baseline, week 11 (Study 1) and week 24 (Studies 2 and 3). In Study 1, vaginal pH fell from 4.56 ± 0.15 at baseline to 4.00 ± 0.12 at Week 11 (P=0.021). In Studies 2 and 3, vaginal pH fell from 4.66 ± 0.21 at baseline to 4.08 ± 0.13 at 12 weeks and remained lower at 4.33 ± 0.097 at 24 weeks(P=0.0135). Application of the vaginal hygiene system was associated with reduced BV recurrence rates (7.7% in the first pilot study and 17.6% in subsequent studies), even in the absence of microbiome community shifts. Importantly, the intervention ameliorated symptoms of vaginal discomfort, indicating an improved vulvovaginal health state associated with a reduction in vaginal pH. These outcomes highlight the potential of this hygiene system to modify the vaginal environment by lowering the pH to support the health of the vaginal microbiome. Indeed, biofilm formation by the BV-associated bacterium (BVAB)Gardnerella vaginalis is enhanced at pH 5 to 6.5, the typical vaginal pH range during BV. A higher vaginal pH is thought to potentiate G. vaginalis adhesion to the vaginal epithelia and result in less interference byLactobacillus species. Gardnerella biofilm formation is the foundation for other BVAB to colonize and facilitates the BV-associated microbial communities that are associated with BV. In contrast, lower pH (<4.5)typically seen in lactobacilli-dominant states result in weak Gardnerella biofilms in vitro.

Conclusion: Based on the findings in these pilot studies, the use of a vaginal hygiene system has demonstrated promise in supporting optimal vaginal health and managing recurrent BV in pre- and post-menopausal women. By lowering vaginal pH and supporting a health-associated vaginal environment, this approach addresses a critical gap in the management of BV, particularly in menopause, where the lack of estrogen is already associated with an elevated vaginal pH. This strategy is crucial for creating a vaginal environment less susceptible to pathogens and more supportive of lactobacilli and their metabolism,directly addressing the challenges posed by the increased vaginal pH typically seen in menopause. Further research is warranted to explore the longer-term effects of the hygiene system and to refine diagno sticand management strategies for BV in the menopausal demographic.