Intravaginal cooling provides symptom relief in women with vulvovaginal candidiasis and reduces immunopathology in an accompanying mouse model.

Background: Vulvovaginal candidiasis (VVC), caused primarily by Candida albicans, is currently treated with either prescription or over-the-counter antifungal drugs, often with variable efficacy and relapses. New and improved therapeutic strategies, including drug-free treatment alternatives, are needed. Upon overgrowth or environmental triggers, C. albicans yeast transitions into hyphae that results in an aberrant immunopathologic response by neutrophils, contributing to the characteristic vulvovaginal symptoms. The purpose of this study was to evaluate the efficacy of a patented intravaginal cooling device (Vlisse®) to provide symptom relief in women with VVC via putative reversal of C. albicans hyphae to the commensal yeast form, with additional proof of principle in an animal model.

Methods: This pilot clinical trial involved five women with VVC who used the device twice daily for three days. Vulvovaginal symptoms were monitored and scored for each use, followed by pelvic examination 30 days post-treatment. An established mouse model of VVC, using cooled magnetic micro stir rods for vaginal cooling, was employed to evaluate the effect on fungal morphology and vaginal immunopathology.

Results: Clinical cure, defined as complete reduction in symptoms without recurrence over a 30-day follow-up period, was achieved in all women. In the mouse model, the insertion of pre-cooled magnetic rods intravaginally for short periods, twice daily for 3 days, reduced the immunopathogenic neutrophil infiltration and hyphal presence.

Conclusions: Intravaginal cooling treatment provides clinical cure for VVC with strong proof of concept in an accompanying animal model. The therapeutic efficacy of Vlisse® warrants further testing in large-scale long-term clinical trials.