In a population of women with heightened vulvovaginal sensitivity and recurrent bacterial vaginosis (BV), the use of the Flourish HEC Vaginal Care System is being tested for prevention of BV recurrence over six months of use.
BV treated with metronidazole or clindamycin recurs within 3 months in at least 43% of women, requiring additional rounds of antibiotics. Preliminary data show that the use of a commercially available 3-component kit can dramatically reduce BV recurrence over 11 weeks of use. This study tests a similar kit with one component altered - the intravaginal gel is composed of hydroxyethylcellulose rather than aloe, making it less likely to trigger reactions in women with sensitive tissues. The study will examine recurrence of BV, vaginal pH, and vulvovaginal symptoms as in the prior study, though extended to 6 months. Additionally, this study examines changes in the vaginal microbiome using targeted next-generation sequencing with the use of the Flourish HEC system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
6
Center for Pelvic Medicine
Rosemont, Pennsylvania, United States
Change in vaginal microbiome by next-generation sequencing (NGS)
Vaginal swab will be analyzed by commercially available NGS service
Time frame: Baseline to 3 months
Change in vaginal microbiome by next-generation sequencing (NGS)
Vaginal swab will be analyzed by commercially available NGS service
Time frame: Baseline to 6 months
Change in vaginal microbiome by next-generation sequencing (NGS)
Vaginal swab will be analyzed by commercially available NGS service
Time frame: 3 months to 6 months
Change in vaginal microbiome by Nugent scoring
Vaginal smear slide will be Gram stained and Nugent scored
Time frame: Baseline to 3 months
Change in vaginal microbiome by Nugent scoring
Vaginal smear slide will be Gram stained and Nugent scored
Time frame: Baseline to 6 months
Change in vaginal microbiome by Nugent scoring
Vaginal smear slide will be Gram stained and Nugent scored
Time frame: 3 months to 6 months
BV recurrence
Percentage of women with recurrence of BV during the study after initial cure with routine care, if applicable
Time frame: 6 months
Change in vulvovaginal symptoms questionnaire (VSQ) self-report
Vaginal and vulvar symptoms will be self-reported using validated VSQ modified to 4-point Likert scores. VSQ consists of a series of questions, each of which is rated as 0 (never), 1(rarely), 2(sometimes), 3 (frequently). Lower scores are healthier. Each question is analyzed separately; there is no overall score reported.
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Time frame: Baseline to 3 months
Change in vulvovaginal symptoms questionnaire (VSQ) self-report
Vaginal and vulvar symptoms will be self-reported using validated VSQ modified to 4-point Likert scores. VSQ consists of a series of questions, each of which is rated as 0 (never), 1(rarely), 2(sometimes), 3 (frequently). Lower scores are healthier. Each question is analyzed separately; there is no overall score reported.
Time frame: Baseline to 6 months
Change in vulvovaginal symptoms questionnaire (VSQ) self-report
Vaginal and vulvar symptoms will be self-reported using validated VSQ modified to 4-point Likert scores. VSQ consists of a series of questions, each of which is rated as 0 (never), 1(rarely), 2(sometimes), 3 (frequently). Lower scores are healthier. Each question is analyzed separately; there is no overall score reported.
Time frame: 3 months to 6 months
Change in vaginal pH
Vaginal pH will be tested using pH strip
Time frame: Baseline to 3 months
Change in vaginal pH
Vaginal pH will be tested using pH strip
Time frame: Baseline to 6 months
Change in vaginal pH
Vaginal pH will be tested using pH strip
Time frame: 3 months to 6 months