Effects of Flourish on Recurrent Urinary Tract Infection

Vaginal Biome Science

Status: Completed

Conditions: Urinary Tract Infections

Treatments: Device: BioNourish, a component of Flourish HEC

Study type: Interventional

Funder types: Other

Identifiers

NCT05397782

rUTI0522

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: Female

Ages: 18 to 52 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Pilot Group: Flourish HEC

Experimental group

Description:

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.

Treatment:

Device: BioNourish, a component of Flourish HEC