Vaginal Care System for Menopausal Women With Urinary Tract Infections
Completed · Not applicable
Conditions studied: Urinary Tract Infections, Vaginal Flora Imbalance
In brief
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.
Key facts
- Study ID
- NCT05573334
- Run by
- Vaginal Biome Science
- People needed
- 8
- Starts
- 2023-07-10
- Expected to finish
- 2025-12-08
- Last updated by the study team
- 2026-01-28
Who can join
Age: any, up to 89. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- Center for Urogynecology & Pelvic Reconstructive Surgery — Newark, Delaware, United States
Full record on ClinicalTrials.gov
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