Pelvic Floor DisordersNCT05665569
Effects of Flourish HEC Vaginal Care System on Birth-Related Pelvic Floor Disorders
A study testing Flourish HEC, which contains BioNourish and Routine pelvic physical therapy in people with Pelvic Floor Disorders, run by Vaginal Biome Science at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Floor Disorders
- What is being tested?
- Flourish HEC, which contains BioNourish and Routine pelvic physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2023to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Flourish HEC Vaginal Care System in Postpartum Women Undergoing Pelvic Physical Therapy for Birth-Related Pelvic Floor Disorders
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?
Read more
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.
Read the 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.
- Conditions
- Pelvic Floor Disorders
- Being tested
- Flourish HEC, which contains BioNourish, Routine pelvic physical therapy
- Keywords
- vaginal microbiome, vaginal pH
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flourish HEC, which contains BioNourishDevice
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.
Routine pelvic physical therapyOther
Routine pelvic physical therapy may include external and internal manual techniques, exercises, diaphragmatic breathing exercises, and other modalities.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Flourish HEC, which contains BioNourish; Other: Routine pelvic physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 months
Secondary outcomes (9)
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.
Measured: Baseline to 6 weeks
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 6 weeks
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 6 weeks
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 6 weeks
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start30 Jan 2023
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaginal Biome Science
- Sponsor type
- University, hospital or other
- Collaborators
- Empower Yourself PT
- Responsible party
- Sponsor
- Investigators
- Karen Kowenski, DPT, Principal investigator, Empower Yourself PT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665569
- Sponsor's protocol ID
- PPT0922
- Status last verified
- Jul 2023
- First submitted
- 16 Dec 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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
World Health Organization. Use and Procurement of Additional Lubricants for Male and Female Condoms: WHO/UNFPA/FHI360 Advisory Note.; 2012:1-8.
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.
PubMed 34903740France 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.
PubMed 33228810Dezzutti 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.
PubMed 23144863Wilkinson 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.
PubMed 31539059Ravel 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.
PubMed 20534435Ananthapadmanabhan 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.
PubMed 14728695
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flourish HEC Vaginal Care System in Postpartum Women Undergoing Pelvic Physical Therapy for Birth-Related Pelvic Floor Disorders
- ClinicalTrials.gov ID
- NCT05665569
- Acronym / sponsor ID
- PPT0922
- Conditions
- Pelvic Floor Disorders
- Keywords
- vaginal microbiome, vaginal pH
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vaginal Biome ScienceUniversity, hospital or other
- Collaborators
- Empower Yourself PT
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | Active comparator | Other: Routine pelvic physical therapyWomen will undergo routine pelvic physical therapy for birth-related pelvic floor disorders as determined by their physical therapist who is also the Principal Investigator. |
| Flourish HEC | Experimental | Device: Flourish HEC, which contains BioNourish, Other: Routine pelvic physical therapyIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flourish HEC, which contains BioNourishThe 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. | Device | Flourish HEC |
| Routine pelvic physical therapyRoutine pelvic physical therapy may include external and internal manual techniques, exercises, diaphragmatic breathing exercises, and other modalities. | Other | Flourish HEC, Routine Care |
Primary outcome
Changes in vaginal microbiome over time
Time frame: Baseline to 6 weeks
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.
Changes in vaginal microbiome over time
Time frame: Baseline to 3 months
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.
Changes in vaginal pH over time
Time frame: Baseline to 6 weeks
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.
Changes in vaginal pH over time
Time frame: Baseline to 3 months
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.
9 secondary outcomes
Changes in pelvic floor muscle strength over time
Time frame: Baseline to 6 weeks
Changes in pelvic floor muscle strength over time
Time frame: Baseline to 3 months
Changes in pelvic floor muscle tension over time
Time frame: Baseline to 6 weeks
Changes in pelvic floor muscle tension over time
Time frame: Baseline to 3 months
Changes in vulvovaginal tissue inflammation over time
Time frame: Baseline to 6 weeks
Changes in vulvovaginal tissue inflammation over time
Time frame: Baseline to 3 months
Changes in vulvovaginal symptoms over time
Time frame: Baseline to 6 weeks
Changes in vulvovaginal symptoms over time
Time frame: Baseline to 3 months
Time to resolution of most bothersome symptom (MBS)
Time frame: Baseline to 3 months
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- BackgroundChidawanyika 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
- BackgroundWorld Health Organization. Use and Procurement of Additional Lubricants for Male and Female Condoms: WHO/UNFPA/FHI360 Advisory Note.; 2012:1-8.
- Background: PubMed 34903740Laniewski 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.
- Background: PubMed 33228810France 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.
- Background: PubMed 23144863Dezzutti 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.
- Background: PubMed 31539059Wilkinson 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.
- Background: PubMed 20534435Ravel 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.
- Background: PubMed 14728695Ananthapadmanabhan 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.
- Individual participant dataSharing planned: No
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Urinary Incontinence (UI)
Not yet recruiting
Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
Vestibulodynia, Vulvodynia
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Kowenski, DPT principal investigator
Empower Yourself PT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flourish HEC, which contains BioNourish and Routine pelvic physical therapy in people with Pelvic Floor Disorders, run by Vaginal Biome Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in vaginal microbiome over time (time frame: Baseline to 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665569, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.