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| Name | Class |
|---|---|
| Center for Pelvic Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Women with recurrent BV use the Flourish HEC Vaginal Care System, consisting of three components: 1) "Balance" external wash; 2) BioNourish vaginal moisturizing gel (an FDA 510k cleared class II medical device); and 3) BiopHresh homeopathic vaginal suppository with probiotics. All system components are currently available to the public at national retailers. Women will use the system for six months. They will have vaginal microbiome composition (next-generation sequencing and Nugent score) and vaginal pH tested at baseline, 3 months, and 6 months. At each timepoint they will also complete the vulvovaginal symptoms questionnaire (VSQ). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components) | Device | see arm description |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in vaginal microbiome by next-generation sequencing (NGS) | Vaginal swab will be analyzed by commercially available NGS service | Baseline to 3 months |
| Change in vaginal microbiome by next-generation sequencing (NGS) | Vaginal swab will be analyzed by commercially available NGS service | Baseline to 6 months |
| Change in vaginal microbiome by next-generation sequencing (NGS) | Vaginal swab will be analyzed by commercially available NGS service | 3 months to 6 months |
| Change in vaginal microbiome by Nugent scoring | Vaginal smear slide will be Gram stained and Nugent scored | Baseline to 3 months |
| Change in vaginal microbiome by Nugent scoring | Vaginal smear slide will be Gram stained and Nugent scored | Baseline to 6 months |
| Change in vaginal microbiome by Nugent scoring | Vaginal smear slide will be Gram stained and Nugent scored | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Kellogg-Spadt, PhD, CRNP | Center for Pelvic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Pelvic Medicine | Rosemont | Pennsylvania | 19010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Chidawanyika, Tamutenda PhD; Cathy Yi, Chung Hwa MD; Kelly-Martin, Rachel; Cleland, Joshua PhD; DuPriest, Elizabeth PhD Preliminary Data from Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent BV [A80], Obstetrics & Gynecology: May 2022 - Volume 139 - Issue - p 24S doi: 10.1097/01.AOG.0000826648.49549.01 |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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A single group of women with recurrent bacterial vaginosis who elect to participate in the study will be assessed before and after using a vaginal care system.
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| 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. | 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. | 3 months to 6 months |
| Change in vaginal pH | Vaginal pH will be tested using pH strip | Baseline to 3 months |
| Change in vaginal pH | Vaginal pH will be tested using pH strip | Baseline to 6 months |
| Change in vaginal pH | Vaginal pH will be tested using pH strip | 3 months to 6 months |
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |