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Enrolling By Invitation NCT05665569

Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders

Conditions: Pelvic Floor Disorders

Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 40
Sponsor: Sexual Health and Wellness Institute

Location: United States

Summary

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 microbiomevaginal pHpelvic muscle strengthpelvic muscle tensionvulvovaginal 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.

Eligibility Criteria

Inclusion Criteria:Women over the age of 18Vaginal delivery within the past yearAttending 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 sessionsExclusion Criteria:Known allergies or sensitivities to any ingredients of the Flourish HEC Vaginal Care SystemImmunosuppressed or otherwise immunocompromisedVaginal 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 antibioticsSurgery within the past 3 monthsPregnant or trying to conceive during the trialRecent (within past 6 months) usage of any Good Clean Love productsPsychiatric/mental disorders triggered by questions related to vulvar or vaginal health, by pelvic exams

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05665569). StuddyBuddy aggregates publicly available trial information.