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Vaginal Care System for Menopausal Women With Urinary Tract Infections

NCT05573334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-01-28

No results posted yet for this study

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

Interventions

DEVICE

BioNourish

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.

Sponsors & Collaborators

  • ChristianaCare

    collaborator OTHER

  • Vaginal Biome Science

    lead OTHER

Principal Investigators

  • Helen Cohen, MS, RN, WHNP-BC · ChristianaCare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2025-12-08
Completion
2025-12-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573334 on ClinicalTrials.gov