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Completed

NCT Number: NCT05397782

Effects of Flourish on Recurrent Urinary Tract Infection

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–52 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

WISH A Place for Women

Nashville, Tennessee, 37209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premenopausal cis women aged 18-52 who are in generally good health
  • 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

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

Treatment and study plan

BioNourish, a component of Flourish HEC

Device

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. 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.

  2. Vaginal pH

    Time frame: Baseline to 6 months

    Vaginal pH will be tested by pH strip.

  3. Vaginal pH

    Time frame: Baseline to 3 months

    Vaginal pH will be tested by pH strip.

  4. Vaginal pH

    Time frame: 3 months to 6 months

    Vaginal pH will be tested by pH strip.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Vaginal Biome Science

Other

Collaborators

  • Urology Associates, P.C., Tennessee

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 31, 2022
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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