This study is designed to determine whether improving the vaginal microbiome in women with localized provoked vulvodynia (LPV) may help improve pain better than routine care alone. The study randomizes women with LPV to either routine care or routine care plus a vaginal hygiene system designed to improve the vaginal microbiome. Women will be assessed for vaginal microbiome, vaginal pH, and pain before enrollment and after 6 weeks, and after 3 months. Women will also have pain assessed 2 weeks after enrollment without assessing vaginal microbiome and pH.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Vaginal microbiome in women with localized provoked vulvodynia (LPV)
Timeframe: Baseline
Changes in the vaginal microbiome in women with localized provoked vulvodynia (LPV) with and without Flourish HEC
Timeframe: Baseline to 6 weeks.
Changes in the vaginal microbiome in women with localized provoked vulvodynia (LPV) with and without Flourish HEC
Timeframe: Baseline to 3 months.
Changes in the vaginal microbiome in women with localized provoked vulvodynia (LPV) with and without Flourish HEC
Timeframe: 6 weeks to 3 months.
Pain intensity by cotton swab test
Timeframe: Baseline to 2 weeks to 6 weeks to 3 months.
Vulvovaginal symptoms questionnaire (VSQ) and addendum
Timeframe: Baseline to 2 weeks to 6 weeks to 3 months.