Vaginal Care System for Menopausal Women With Urinary Tract Infections

What this trial studies

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).

Conditions in scope

• Urinary Tract Infections
• Vaginal Flora Imbalance

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…

Who can join

Women only · Up to 89 Years

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
• Women with an obstruction or neurogenic bladder causing incomplete bladder emptying.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2023-07-10
• Primary completion: 2025-12-08
• Last update posted: 2026-01-28
• First posted: 2022-10-10

Sponsor & contact

Lead sponsor: Vaginal Biome Science (Other)

Collaborators: ChristianaCare

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in vaginal microbiome composition (Baseline to 3 and 6 months in a repeated measures assessment.)
  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…
• Change in vaginal pH (Baseline to 3 and 6 months in a repeated measures assessment.)
  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.
• Frequency of UTI (6 months duration of study)
  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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.