Effects of Flourish on Recurrent Urinary Tract Infection

Vaginal Biome Science14 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Urinary Tract Infections

Interventions

BioNourish, a component of Flourish HECDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 52 Years

Medical Language ↔ Plain English

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

Locations (1)

WISH A Place for Women

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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).

Time frame: Baseline to 3 months

Vaginal Microbiome

Time frame: Baseline to 6 months

Vaginal Microbiome

Time frame: 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).

Time frame: Baseline to 6 months

Secondary Outcomes

Associations between microbes and UTI

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.

Time frame: Baseline to 6 months.

Data from ClinicalTrials.gov

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