Effects of Flourish on Recurrent Urinary Tract Infection

NCT05397782 | Completed FDA Device

• 1 other identifier: rUTI0522
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infections

Keywords

vaginal microbiome; microbiome; probiotic; lactobacillus; vulvovaginal symptoms questionnaire; vaginal pH

Outcome Measures

Primary Outcomes (4)

• Vaginal Microbiome

  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

  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

  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

  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 Outcomes (7)

• Associations between microbes and UTI

  Baseline to 6 months.

• Vaginal pH

  Baseline to 6 months

• Vaginal pH

  Baseline to 3 months

• Vaginal pH

  3 months to 6 months

• Vulvovaginal symptoms questionnaire (VSQ) + addendum

  Baseline

Study Arms (1)

Pilot Group: Flourish HEC

EXPERIMENTAL

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

Interventions

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.

Pilot Group: Flourish HEC

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vaginal Biome Science: lead
• Urology Associates, P.C., Tennessee: collaborator

Study Sites (1)

WISH A Place for Women

Nashville, Tennessee, 37209, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Brooke Faught, DNP

  Women's Institute of Sexual Health / Urology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single group of women with recurrent symptomatic UTI will be studied longitudinally while using the intervention system. Results will be compared with historical controls.

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: May 31, 2022
• Study Start: September 26, 2022
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)