Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders
Stopped early · Not applicable
Conditions studied: Pelvic Floor Disorders
In brief
The goal of this clinical trial is to learn about how the vaginal microbiome affects pelvic floor disorders in women who have recently given birth. The main question it aims to answer is: • Can improving the vaginal microbiome allow women to improve muscle strength, improve muscle tone, and reduce tissue inflammation faster than women who do not use a vaginal hygiene system to improve their microbiome? Over a 3-month period, participants will be assessed three times for: * vaginal microbiome * vaginal pH * pelvic muscle strength * pelvic muscle tension * vulvovaginal tissue color At each of these 3 assessments, women will answer questions on a questionnaire. Half of the women will be asked to use a vaginal hygiene system at home during these 3 months. Researchers will compare use of a three-product vaginal hygiene system plus a specific vaginal lubricant to see if using these products improves the vaginal microbiome and the pelvic floor outcomes listed above.
Key facts
- Study ID
- NCT05665569
- Run by
- Vaginal Biome Science
- People needed
- 1
- Starts
- 2023-01-30
- Expected to finish
- 2023-03-29
- Last updated by the study team
- 2023-07-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women over the age of 18
- Vaginal delivery within the past year
- Attending a pelvic physical therapy clinic treatment of birth-related pelvic floor disorder with one or more of the following symptoms: vulvovaginal pain, pelvic/bladder pain, urinary or fecal incontinence, or dyspareunia.
- Needing approximately three months of treatment sessions
You may not qualify if…
- Known allergies or sensitivities to any ingredients of the Flourish HEC Vaginal Care System
- Immunosuppressed or otherwise immunocompromised
- Vaginal infection at the start of the study other than bacterial vaginosis or yeast infection (these may be treated prior to starting the protocol)
- Current use of any antibiotics
- Surgery within the past 3 months
- Pregnant or trying to conceive during the trial
- Recent (within past 6 months) usage of any Good Clean Love products
- Psychiatric/mental disorders triggered by questions related to vulvar or vaginal health, by pelvic exams
Where it is running
- Empower Yourself PT — Bellaire, Texas, United States
Full record on ClinicalTrials.gov
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