Vaginal Care System for Menopausal Women With Urinary Tract Infections

NCT05573334 | Completed FDA Device

• 1 other identifier: MUTI0822
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Menopausal women have an increased risk of recurrent urinary tract infections. This is likely due in part to hormonal changes occurring during menopause. As estrogen falls, the vaginal microbiome shifts from a healthy one to a less healthy one. Because the vagina is close to the urethra, this vaginal microbiome shift contributes to a loss of protection against urinary tract infections (UTIs). The investigators are asking whether improving the vaginal microbiome using an over-the-counter vaginal hygiene system can reduce frequency of recurrent UTI in menopausal women.

Conditions

Urinary Tract Infections; Vaginal Flora Imbalance

Keywords

Recurrent urinary tract infection; Vaginal microbiome; Probiotic; Lactobacillus

Outcome Measures

Primary Outcomes (3)

• Change in vaginal microbiome composition

  The vaginal microbiome will be assessed using a whole-genome sequencing method at baseline, 3 months, and 6 months. Each measurement will be assigned to one of several "community state types" (CSTs). This outcome examines whether vaginal microbiome shifts from unhealth (CST IV) to intermediate (CST III) or healthy (CST I, II, or V) types over time. This is a three-way repeated measures analysis using study arm, time, and level of CST (healthy, intermediate, unhealthy) as factors.

  Baseline to 3 and 6 months in a repeated measures assessment.

• Change in vaginal pH

  The vaginal pH will be assessed using a colorimetric paper strip at baseline, 3 months, and 6 months. This outcome examines numeric changes in pH over time. This is a three-way repeated measures analysis using study arm, time, and pH level as factors.

  Baseline to 3 and 6 months in a repeated measures assessment.

• Frequency of UTI

  The mean number of UTIs experienced per participant during the 6-month study period will be compared between control and experimental arms using a Student's t-test.

  6 months duration of study

Secondary Outcomes (1)

• Frequency of UTI with estrogen-use covariate

  6 months duration of study

Study Arms (2)

Routine Care

NO INTERVENTION

The Routine Care arm is a control group receiving no study intervention. They receive whatever routine care is standard for the study PI's treatment of usual recurrent UTI patients, including antibiotics for active infections, estrogen and supplements for prevention of infection.

Flourish HEC

EXPERIMENTAL

The experimental (or intervention) arm uses 3 products in a vaginal hygiene system in addition to any routine care they would normally receive. These 3 products are a vulvar wash (for external use), a vaginal moisturizing gel (BioNourish), and a vaginal homeopathic suppository with probiotics. The vulvar wash is used daily or as often as a participant bathes/showers. The vaginal moisturizing gel, which is formulated to match healthy vaginal secretions for pH, osmolality, and lactic acid levels, is used every day before bed. The vaginal homeopathic suppository with probiotics is used every 3rd day before bed. This suppository contains native vaginal probiotic species associated with healthy vaginal microbiomes.

Device: BioNourish

Interventions

BioNourish DEVICE

BioNourish is a 510k-cleared class II medical device that has been on the market for over two years. It is a vaginal moisturizing gel that is designed with pH, osmolality, and lactic acid levels that match those observed in healthy vaginas. It does not have an "active ingredient", but only provides moisture in a formula that is matched for physicochemical characteristics to healthy vaginal fluid.

Flourish HEC

Eligibility Criteria

• Age: Up to 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal women who are in generally good health, including those with chronic conditions adequately controlled by common medications. Post-menopausal is defined as \>12 months since last menstrual period. Menopause may be natural or induced due to surgical or medical intervention.
• 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:

• Immunosuppressed
• Known allergies to aloe vera or to other components of BioNourish®, Balance, or BiopHresh®
• Known vaginal infection other than bacterial vaginosis (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 who wear a pessary
• Women who use catheters regularly
• Women with an obstruction or neurogenic bladder causing incomplete bladder emptying.

Sponsors & Collaborators

• Vaginal Biome Science: lead
• ChristianaCare: collaborator

Study Sites (1)

Center for Urogynecology & Pelvic Reconstructive Surgery

Newark, Delaware, 19713, 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

• Helen Cohen, MS, RN, WHNP-BC

  ChristianaCare

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Study Start: July 10, 2023
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)