Effects of Flourish on Recurrent Urinary Tract Infection

NCT ID: NCT05397782

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2024-02-21

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.

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.

Conditions

Urinary Tract Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BioNourish, a component of Flourish HEC

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Urology Associates, P.C., Tennessee

OTHER

Sponsor Role: collaborator

Vaginal Biome Science

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brooke Faught, DNP

Role: PRINCIPAL_INVESTIGATOR

Women's Institute of Sexual Health / Urology Associates

Locations

WISH A Place for Women

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

rUTI0522

Identifier Type: -

Identifier Source: org_study_id