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

Pelvic Floor Disorders Clinical Trial

Official title:

Effects of Flourish HEC Vaginal Care System in Postpartum Women Undergoing Pelvic Physical Therapy for Birth-Related Pelvic Floor Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05665569
• Other study ID #: PPT0922
• Status: Terminated
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: March 29, 2023

Study information

• Verified date: July 2023
• Source: Vaginal Biome Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Device:
• Flourish HEC, which contains BioNourish
The Flourish HEC vaginal hygiene system comprises Balance intimate wash used daily, BioNourish vaginal moisturizing gel used daily, and BiopHresh homeopathic vaginal suppository containing probiotics, used once every 3 days. In addition, for all therapy requiring insertion in the clinic or at home, or for sex if desired, BioNude personal lubricant will be used. These four products are intended to allow the vaginal microbiome to self-correct by supporting the vaginal environment in terms of providing pH, osmolality, and lactic acid levels that match those in a healthy vagina.

Other:
• Routine pelvic physical therapy
Routine pelvic physical therapy may include external and internal manual techniques, exercises, diaphragmatic breathing exercises, and other modalities.

Locations

Country	Name	City	State
United States	Empower Yourself PT	Bellaire	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Vaginal Biome Science	Empower Yourself PT

Country where clinical trial is conducted

United States, 

References & Publications (8)

Ananthapadmanabhan KP, Moore DJ, Subramanyan K, Misra M, Meyer F. Cleansing without compromise: the impact of cleansers on the skin barrier and the technology of mild cleansing. Dermatol Ther. 2004;17 Suppl 1:16-25. doi: 10.1111/j.1396-0296.2004.04s1002.x. — View Citation

Chidawanyika T, Yi CHC, Kelly-Martin R, Cleland J, DuPriest E. Clinical trial to survey results of Flourish vaginal care system for recurrent BV [A80]. Obstet Gynecol. 2022;139:24S. doi:10.1097/01.AOG.0000826648.49549.01

Dezzutti CS, Brown ER, Moncla B, Russo J, Cost M, Wang L, Uranker K, Kunjara Na Ayudhya RP, Pryke K, Pickett J, Leblanc MA, Rohan LC. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One. 2012;7(11):e48328. doi: 10.1371/journal.pone.0048328. Epub 2012 Nov 7. — View Citation

France MT, Ma B, Gajer P, Brown S, Humphrys MS, Holm JB, Waetjen LE, Brotman RM, Ravel J. VALENCIA: a nearest centroid classification method for vaginal microbial communities based on composition. Microbiome. 2020 Nov 23;8(1):166. doi: 10.1186/s40168-020-00934-6. — View Citation

Laniewski P, Herbst-Kralovetz MM. Bacterial vaginosis and health-associated bacteria modulate the immunometabolic landscape in 3D model of human cervix. NPJ Biofilms Microbiomes. 2021 Dec 13;7(1):88. doi: 10.1038/s41522-021-00259-8. — View Citation

Ravel J, Gajer P, Abdo Z, Schneider GM, Koenig SS, McCulle SL, Karlebach S, Gorle R, Russell J, Tacket CO, Brotman RM, Davis CC, Ault K, Peralta L, Forney LJ. Vaginal microbiome of reproductive-age women. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4680-7. doi: 10.1073/pnas.1002611107. Epub 2010 Jun 3. — View Citation

Wilkinson EM, Laniewski P, Herbst-Kralovetz MM, Brotman RM. Personal and Clinical Vaginal Lubricants: Impact on Local Vaginal Microenvironment and Implications for Epithelial Cell Host Response and Barrier Function. J Infect Dis. 2019 Nov 6;220(12):2009-2018. doi: 10.1093/infdis/jiz412. — View Citation

World Health Organization. Use and Procurement of Additional Lubricants for Male and Female Condoms: WHO/UNFPA/FHI360 Advisory Note.; 2012:1-8.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in vaginal microbiome over time	Vaginal microbiome composition will be assessed by whole-genome sequencing at three timepoints; this outcome assesses the initial 6-week time period. Individual biomes will be categorized as healthy, intermediate, or unhealthy using the VALENCIA model to assign community state types (CSTs). CSTs I, II, and V are "healthy"; CST III is "intermediate"; CST IV is "unhealthy". Changes over time will be analyzed by Krusal-Wallis.	Baseline to 6 weeks
Primary	Changes in vaginal microbiome over time	Vaginal microbiome composition will be assessed by whole-genome sequencing at three timepoints; this outcome assesses the entire duration of the study. Individual biomes will be categorized as healthy, intermediate, or unhealthy using the VALENCIA model to assign community state types (CSTs). CSTs I, II, and V are "healthy"; CST III is "intermediate"; CST IV is "unhealthy". Changes over time will be analyzed by Krusal-Wallis.	Baseline to 3 months
Primary	Changes in vaginal pH over time	Vaginal pH will be assessed using colorimetric pH test strips at three timepoints; this outcome assesses the initial 6-week period. Data will be analyzed by repeated measures ANOVA.	Baseline to 6 weeks
Primary	Changes in vaginal pH over time	Vaginal pH will be assessed using colorimetric pH test strips at three timepoints; this outcome assesses the entire study duration. Data will be analyzed by repeated measures ANOVA.	Baseline to 3 months
Secondary	Changes in pelvic floor muscle strength over time	Changes in pelvic floor muscle strength will be assessed by vaginal palpation using the Modified Oxford Grading System, a Likert scoring system on a scale of 0 to 5, with 0 being no contraction, and 5 being strong contraction. This outcome assesses the initial 6-week period. Data will be analyzed by Kruskal-Wallis.	Baseline to 6 weeks
Secondary	Changes in pelvic floor muscle strength over time	Changes in pelvic floor muscle strength will be assessed by vaginal palpation using the Modified Oxford Grading System, a Likert scoring system on a scale of 0 to 5, with 0 being no contraction, and 5 being strong contraction. This outcome assesses the entire study duration. Data will be analyzed by Kruskal-Wallis.	Baseline to 3 months
Secondary	Changes in pelvic floor muscle tension over time	Changes in pelvic floor muscle tension will be assessed by vaginal palpation using a Likert scoring system on a scale of 0 to 5, with 0 being no muscle tension, and 5 being high muscle tension. This outcome assesses the initial 6-week period. Data will be analyzed by Kruskal-Wallis.	Baseline to 6 weeks
Secondary	Changes in pelvic floor muscle tension over time	Changes in pelvic floor muscle tension will be assessed by vaginal palpation using a Likert scoring system on a scale of 0 to 5, with 0 being no muscle tension, and 5 being high muscle tension. This outcome assesses the entire study duration. Data will be analyzed by Kruskal-Wallis.	Baseline to 3 months
Secondary	Changes in vulvovaginal tissue inflammation over time	Changes in vulvovaginal tissue inflammation will be assessed by assigning tissue color using a Likert scoring system on a scale of 0 to 3, with 0 being blanched tissue, 1 being healthy pink tissue, 2 being dark pink, and 3 being red inflamed tissue. This outcome assesses the initial 6-week period. Data will be analyzed by Kruskal-Wallis.	Baseline to 6 weeks
Secondary	Changes in vulvovaginal tissue inflammation over time	Changes in vulvovaginal tissue inflammation will be assessed by assigning tissue color using a Likert scoring system on a scale of 0 to 3, with 0 being blanched tissue, 1 being healthy pink tissue, 2 being dark pink, and 3 being red inflamed tissue. This outcome assesses the entire study duration. Data will be analyzed by Kruskal-Wallis.	Baseline to 3 months
Secondary	Changes in vulvovaginal symptoms over time	Changes in vulvovaginal symptoms will be assessed by questionnaires using either yes/no (Vulvovaginal Symptoms Questionnaire) or Likert-based scoring (scale of 0 to 3, where 0 is no symptom and 3 is severe or all the time). This outcome assesses the initial 6-week period. Data will be analyzed by Mann-Whitney U or Kruskal-Wallis as appropriate per question.	Baseline to 6 weeks
Secondary	Changes in vulvovaginal symptoms over time	Changes in vulvovaginal symptoms will be assessed by questionnaires using either yes/no (Vulvovaginal Symptoms Questionnaire) or Likert-based scoring (0 to 3, with 0 being no symptom and 3 being severe or all the time). This outcome assesses the entire study duration. Data will be analyzed by Mann-Whitney U or Kruskal-Wallis as appropriate per question.	Baseline to 3 months
Secondary	Time to resolution of most bothersome symptom (MBS)	Each participant's MBS will be tracked to determine which week of the study the participant no longer reported experiencing that symptom. Time to resolution of the MBS will be analyzed by Kaplan-Meier.	Baseline to 3 months