Clinical trial NCT05665569: Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders
Official title: Effects of Flourish HEC Vaginal Care System in Postpartum Women Undergoing Pelvic Physical Therapy for Birth-Related Pelvic Floor Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Floor Disorders
Keywords: vaginal microbiome
vaginal pH
Lead sponsor: Vaginal Biome Science
Sponsor class: OTHER
Collaborators: name: Empower Yourself PT
First posted: 2022-12-27
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Detailed description: The vaginal microbiome interacts with vaginal epithelial cells and host immune cells in varying ways depending on the presence of particular species. Presence of high quantities of Lactobacillus species, which are considered healthy, downregulate pro-inflammatory markers and upregulate anti-inflammatory markers. On the other hand, BV-associated bacteria such as Gardnerella vaginalis, Atopobium (Fannyhessea) vaginae, Prevotella bivia, Mobiluncus curtisii and others are associated with increased pro-inflammatory markers and reduced anti-inflammatory molecules. The investigators predict that improving the vaginal microbiome by using an over-the-counter vaginal care system will increase levels of Lactobacillus species, reduce levels of BV-associated bacteria, and reduce overall tissue inflammation, thereby speeding tissue healing.

The original Flourish® Vaginal Care System, with slightly different vaginal moisturizer (with aloe), has recently been shown in a clinical study to reduce vaginal pH from 4.81 (unhealthy, elevated) to 4.05 (healthy) and prevent recurrence of bacterial vaginosis over a 10-week study period. The proposed study uses a newly formulated product that is gentler (no aloe) because the study population is likely to have high sensitivity based on inclusion criteria involving tissue trauma.

Pelvic floor disorders (or pelvic floor dysfunction) affect a large percentage of females around the globe that may manifest as vulvovaginal pain, pelvic/bladder pain, urinary or fecal incontinence, pelvic organ prolapse, urinary urgency, urinary frequency, and much more. It can take on several forms, including either weakness of pelvic floor muscles (causing incontinence or prolapse), or excessive tightness (hypertonia) of the same muscles; sometimes these occur simultaneously in the same individual. Pelvic floor disorders can significantly disrupt daily life, for example causing patients to wake up multiple times in the night to urinate, or causing leakage of urine or feces at inopportune times, causing women to make dramatic changes to their lives to avoid embarrassing situations or pain. In addition, incontinence may be responsible for urinary tract and vaginal infections.

Women who have given birth vaginally often experience trauma to the pelvic floor that results in pelvic floor disorders. They often seek treatment from physical therapists, which may begin as early as six weeks after delivery or may not occur until years after the initial trauma. Pelvic physical therapy interventions can include exercises, diaphragmatic breathing techniques, external and internal manual techniques, and other modalities to improve muscle strength, muscle tension, tissue inflammation, and reduce degree of symptoms.

Pelvic physical therapy often involves manual techniques such as myofascial release, soft tissue mobilization, and scar tissue mobilization in conjunction with dilator use at home to reduce tension in the muscles of the pelvic floor muscles. Lubricants are typically used on the finger or device to ease insertion. However, many lubricants, including some of those used clinically, have been shown to cause excessive exfoliation of vaginal epithelial cells and to induce dysbiosis. The most damaging lubricants are those that are hyperosmolar and those which contain specific antimicrobial ingredients, such as nonoxynol-9, chlorhexidine gluconate, polyquaternium-15, and parabens. The investigators hypothesize that use of lubricants such as these increase inflammation in the vagina, slowing the rate of progress in physical therapy and possibly causing conditions such as bacterial vaginosis, aerobic vaginitis, or vaginal yeast infections. The investigators predict that using a lubricant designed to closely match healthy vaginal secretions, along with a hygiene system that promotes healthy flora, will enable pelvic physical therapy patients to improve more quickly and/or more completely without complications. The investigators also hypothesize that there may be specific microbiome patterns observed in women with this type of pelvic floor disorder that are distinct from healthy women.

Together, it is hypothesized that using a specific over-the-counter commercially available vaginal hygiene system plus lubricant which have all been formulated with vaginal tissue and microbiome health in mind will improve the vaginal microbiome and help postpartum women achieve their pelvic physical therapy goals faster and/or more thoroughly.

Eligibility criteria: Inclusion Criteria:

1. Women over the age of 18
2. Vaginal delivery within the past year
3. 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.
4. Needing approximately three months of treatment sessions

Exclusion Criteria:

1. Known allergies or sensitivities to any ingredients of the Flourish HEC Vaginal Care System
2. Immunosuppressed or otherwise immunocompromised
3. Vaginal infection at the start of the study other than bacterial vaginosis or yeast infection (these may be treated prior to starting the protocol)
4. Current use of any antibiotics
5. Surgery within the past 3 months
6. Pregnant or trying to conceive during the trial
7. Recent (within past 6 months) usage of any Good Clean Love products
8. Psychiatric/mental disorders triggered by questions related to vulvar or vaginal health, by pelvic exams

Primary outcomes:
measure: Changes in vaginal microbiome over time
timeFrame: Baseline to 6 weeks
measure: Changes in vaginal microbiome over time
timeFrame: Baseline to 3 months
measure: Changes in vaginal pH over time
timeFrame: Baseline to 6 weeks
measure: Changes in vaginal pH over time
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Changes in pelvic floor muscle strength over time
timeFrame: Baseline to 6 weeks
measure: Changes in pelvic floor muscle strength over time
timeFrame: Baseline to 3 months
measure: Changes in pelvic floor muscle tension over time
timeFrame: Baseline to 6 weeks
measure: Changes in pelvic floor muscle tension over time
timeFrame: Baseline to 3 months
measure: Changes in vulvovaginal tissue inflammation over time
timeFrame: Baseline to 6 weeks
measure: Changes in vulvovaginal tissue inflammation over time
timeFrame: Baseline to 3 months
measure: Changes in vulvovaginal symptoms over time
timeFrame: Baseline to 6 weeks
measure: Changes in vulvovaginal symptoms over time
timeFrame: Baseline to 3 months
measure: Time to resolution of most bothersome symptom (MBS)
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: Empower Yourself PT
state: Texas
Study officials:
affiliation: Empower Yourself PT
name: Karen Kowenski, DPT
role: PRINCIPAL_INVESTIGATOR
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