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Vaginal Care System for Menopausal Women With Urinary Tract Infections
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
🗓️ Study Start (Actual) 10 July 2023
🗓️ Primary Completion (Estimated) February 2025
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Newark, Delaware, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. 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.
    • 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. Immunosuppressed
    • 2. Known allergies to aloe vera or to other components of BioNourish®, Balance, or BiopHresh®
    • 3. Known vaginal infection other than bacterial vaginosis (BV) or yeast infection at time of screening
    • 4. Women who have needed changes to medical intervention or in-office procedures in the last 3 months
    • 5. Women who wear a pessary
    • 6. Women who use catheters regularly
    • 7. Women with an obstruction or neurogenic bladder causing incomplete bladder emptying.
Ages Eligible for Study: N/A to 89 Years (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 October 2022
  • First Submitted that Met QC Criteria 6 October 2022
  • First Posted 10 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 July 2023
  • Last Update Posted 19 July 2023
  • Last Verified July 2023
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