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

NCT05665569 | Terminated FDA Device

• 1 other identifier: PPT0922
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders

Keywords

vaginal microbiome; vaginal pH

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (9)

• Changes in pelvic floor muscle strength over time

  Baseline to 6 weeks

• Changes in pelvic floor muscle strength over time

  Baseline to 3 months

• Changes in pelvic floor muscle tension over time

  Baseline to 6 weeks

• Changes in pelvic floor muscle tension over time

  Baseline to 3 months

• Changes in vulvovaginal tissue inflammation over time

  Baseline to 6 weeks

Study Arms (2)

Routine Care

ACTIVE COMPARATOR

Women will undergo routine pelvic physical therapy for birth-related pelvic floor disorders as determined by their physical therapist who is also the Principal Investigator.

Other: Routine pelvic physical therapy

Flourish HEC

EXPERIMENTAL

In addition to routine physical therapy, women will use a 3-component vaginal hygiene system, "Flourish HEC" (HEC = hydroxyethylcellulose to differentiate this system from a prior Flourish system based in aloe) plus a personal lubricant called BioNude.

Device: Flourish HEC, which contains BioNourish; Other: Routine pelvic physical therapy

Interventions

Flourish HEC, which contains BioNourish DEVICE

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.

Flourish HEC

Routine pelvic physical therapy OTHER

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

Flourish HEC; Routine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vaginal Biome Science: lead
• Empower Yourself PT: collaborator

Study Sites (1)

Empower Yourself PT

Bellaire, Texas, 77401, United States

Location

Related Publications (8)

• 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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 34903740 BACKGROUND

• 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.

  PMID: 33228810 BACKGROUND

• 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.

  PMID: 23144863 BACKGROUND

• 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.

  PMID: 31539059 BACKGROUND

• 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.

  PMID: 20534435 BACKGROUND

• 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.

  PMID: 14728695 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Karen Kowenski, DPT

  Empower Yourself PT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: January 30, 2023
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)