Vaginal Care System for Menopausal Women With Urinary Tract Infections (NCT05573334) | Clinical Trial Compass
CompletedNot Applicable
Vaginal Care System for Menopausal Women With Urinary Tract Infections
United States8 participantsStarted 2023-07-10
Plain-language 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.
Who can participate
Age range89 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
✕
What they're measuring
1
Change in vaginal microbiome composition
Timeframe: Baseline to 3 and 6 months in a repeated measures assessment.
2
Change in vaginal pH
Timeframe: Baseline to 3 and 6 months in a repeated measures assessment.