Effects of Flourish on Recurrent Urinary Tract Infection

March 6, 2024 updated by: Vaginal Biome Science

Pilot Study: Effects of Flourish Vaginal Care System in Women With Recurrent Symptomatic Urinary Tract Infections

An over-the-counter vaginal care system is being tested to see if it may be effective in preventing recurrence of symptomatic urinary tract infection (UTI) in women who have had multiple UTIs within the past year.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Women who have a urinary tract infection (UTI) may experience a recurrence within weeks or months of treatment. Some women may experience 8 or more UTIs in a single year, leading to multiple rounds of antibiotics, with the individual risks to organs and risk of antibiotic resistance growing with each round. Alternative methods for prevention of recurrent UTI is therefore desirable. This study will test whether women who use a commercially available, over-the-counter vaginal care system may be able to reduce recurrences of UTI over a six-month period. This is a pilot study designed to determine whether a larger randomized controlled trial in the future would be justified.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • WISH A Place for Women

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Premenopausal cis women aged 18-52 who are in generally good health
  2. History of at least 2 UTIs in the past six months, or three prior UTIs in the past year, documented in the medical record. At least one must be culture-proven.

Exclusion Criteria:

  1. Pregnant or trying to become pregnant
  2. Lactating
  3. Immunosuppressed
  4. Known allergies to aloe vera or to other components of Restore®, Balance or BiopHresh®
  5. Known vaginal infection other than BV or yeast infection at time of screening
  6. Women who have needed changes to medical intervention or in-office procedures in the last 3 months
  7. Women using vaginal acidifying agents or spermicides for contraception
  8. Women who wear a pessary

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilot Group: Flourish HEC
All women in the study will use the Flourish HEC Vaginal Care System for 6 months. Flourish HEC consists of 3 products: 1) Balance, an external feminine wash; 2) BioNourish, a vaginal moisturizing gel; and 3) BiopHresh, a homeopathic vaginal suppository with probiotics. Products are pH-balanced to match healthy vaginal pH (3.5-4.5). BioNourish is formulated to be iso-osmotic with vaginal fluid. Balance and BioNourish contain lactic acid. BiopHresh contains 7 strains of lactobacilli, including Lactobacillus crispatus and other species found in healthy vaginas or shown to be effective probiotics strains.
Device: BioNourish, a component of Flourish HEC
BioNourish, one of three parts of the Flourish HEC system, is a vaginal moisturizing gel - a Class II medical device with FDA 510k clearance obtained in 2020.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vaginal Microbiome
Time Frame: Baseline to 3 months
The vaginal microbiome will be assessed using next-generation sequencing (NGS) technology to assign the biome to one of 5 "community state types" (CST). The outcome will examine whether the vaginal microbiome changes from an unhealthy one (IV or III) to a healthy one (I, II, or V).
Baseline to 3 months
Vaginal Microbiome
Time Frame: Baseline to 6 months
The vaginal microbiome will be assessed using next-generation sequencing (NGS) technology to assign the biome to one of 5 "community state types" (CST). The outcome will examine whether the vaginal microbiome changes from an unhealthy one (IV or III) to a healthy one (I, II, or V).
Baseline to 6 months
Vaginal Microbiome
Time Frame: 3 months to 6 months
The vaginal microbiome will be assessed using next-generation sequencing (NGS) technology to assign the biome to one of 5 "community state types" (CST). The outcome will examine whether the vaginal microbiome changes from an unhealthy one (IV or III) to a healthy one (I, II, or V).
3 months to 6 months
UTI recurrence
Time Frame: Baseline to 6 months
Frequency of symptomatic UTI over study duration will be assessed (number of occurrences per person). UTI will be diagnosed when one or more symptoms is present (urinary urgency, frequency, sense of burning, pelvic pain, fever, flank pain) along with one or more confirming lab tests (positive culture, urine nitrites or leukocytes).
Baseline to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Associations between microbes and UTI
Time Frame: Baseline to 6 months.
Using the NGS sequencing data from primary outcomes 1, 2, and 3, statistical modeling will be used to determine if the presence of specific individual bacteria or combinations of two or more species are associated with increased frequency of UTI.
Baseline to 6 months.
Vaginal pH
Time Frame: Baseline to 6 months
Vaginal pH will be tested by pH strip.
Baseline to 6 months
Vaginal pH
Time Frame: Baseline to 3 months
Vaginal pH will be tested by pH strip.
Baseline to 3 months
Vaginal pH
Time Frame: 3 months to 6 months
Vaginal pH will be tested by pH strip.
3 months to 6 months
Vulvovaginal symptoms questionnaire (VSQ) + addendum
Time Frame: Baseline
Vulvovaginal symptoms will be assessed by questionnaire. Both the validated VSQ and additional questions not previously validated will be used. Most questions will be asked using a 4-point Likert scale (0=not at all, 4 = all the time), except those which are binary in nature.
Baseline
Vulvovaginal symptoms questionnaire (VSQ) + addendum
Time Frame: 3 months
Vulvovaginal symptoms will be assessed by questionnaire. Both the validated VSQ and additional questions not previously validated will be used. Most questions will be asked using a 4-point Likert scale (0=not at all, 4 = all the time), except those which are binary in nature.
3 months
Vulvovaginal symptoms questionnaire (VSQ) + addendum
Time Frame: 6 months
Vulvovaginal symptoms will be assessed by questionnaire. Both the validated VSQ and additional questions not previously validated will be used. Most questions will be asked using a 4-point Likert scale (0=not at all, 4 = all the time), except those which are binary in nature.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vaginal Biome Science

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Urology Associates, P.C., Tennessee

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brooke Faught, DNP, Women's Institute of Sexual Health / Urology Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • rUTI0522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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