Flourish Vaginal Care System to Establish Neovaginal Microbiome

Study Overview
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Brief Summary
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This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.

Detailed Description
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Very little is known about the neovaginal microbiome, but it has been described as being a polymicrobial state similar to bacterial vaginosis (BV) in cis women. The Flourish Vaginal Care System is a commercially-available over-the-counter vaginal wellness kit that helps relieve symptoms of BV. This study is intended to determine whether that kit could also help transgender women who have recently undergone gender-confirming surgery to establish a neovaginal microbiome that is dominated by lactobacilli, as observed in healthy cis women. This could increase health and subjective satisfaction of the neovagina. This study examines the (neo)vaginal microbiome in transgender women with and without using Flourish, as well as a group of healthy cisgender women.

Official Title
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Pilot Study to Observe Effects of Using Flourish Vaginal Care System to Establish Neovaginal Microbiome After Gender-Confirmation Surgery

Conditions
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Neovaginal Microbiome

Intervention / Treatment
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* Device: Flourish Vaginal Care system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Transgender women over age 18 who are preparing to undergo gender-confirmation surgery. Healthy cisgender women ages 18-52 Exclusion Criteria: Immunosuppressed Known allergies or sensitivities to aloe vera or to other components of Restore®, Balance, or BiopHresh® Known (neo)vaginal infection that is not yeast or BV at start of protocol Inability to tolerate Restore gel by day 13 after surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups of transgender women who have undergone surgery plus a group of healthy cisgender women who have not undergone surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Transgender women using Flourish<br>After gender-confirming surgery, this group will use the Flourish Vaginal Care System for six months, ramping up usage with healing. They will use Balance external wash beginning day 6 after surgery; Restore® vaginal moisturizing gel on dilators beginning day 6 after surgery; Restore every other day at bedtime with BiopHresh homeopathic/probiotic suppository every 3rd day at bedtime beginning week 6 after surgery through end of study at 6 months. | Device: Flourish Vaginal Care system<br>* Flourish includes Restore® vaginal moisturizing gel, a Class II medical device cleared by the FDA, in addition to two other kit components<br>|
| No Intervention: Group 2: Transgender women not using Flourish<br>After gender-confirming surgery, this group will use only KY jelly on dilators beginning day 6 after surgery according to routine care; they will use any standard hygiene product (soap, body wash, etc) of their choice except products used by Group 1 through the end of the study at 6 months. | |
| Other: Group 3: Cisgender women<br>This group will use the Flourish Vaginal Care system for 6 months: Balance external wash daily; Restore intravaginal gel every other day at bedtime; BiopHresh homeopathic/probiotic suppository every 3rd day at bedtime through the end of study. | Device: Flourish Vaginal Care system<br>* Flourish includes Restore® vaginal moisturizing gel, a Class II medical device cleared by the FDA, in addition to two other kit components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal microbiome | Observation of changes in the composition of the vaginal fluid microbiome over six months using commercially available next-generation sequencing kit (16s rRNA). Biomes will be categorized to community state type (Ravel 2011), and genus- or species-level relative abundance will be compared. | Collections at time 0, 6 weeks, and 6 months | 
| Vaginal pH | Observation of changes in vaginal pH over six months by pH strip | Collections at time 0, 6 weeks, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VSQ | Responses to the Vulvovaginal Symptoms Questionnaire | Collections at time 0, 6 weeks, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neovagina, microbiome, lactobacillus, transgender, probiotic