Vaginal Care System for Menopausal Women With Urinary Tract Infections

Launched by VAGINAL BIOME SCIENCE · Oct 6, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help menopausal women who often suffer from urinary tract infections (UTIs). As women go through menopause, hormonal changes can disturb the natural balance of bacteria in the vagina, which can lead to more frequent UTIs. The researchers want to find out if using a special over-the-counter vaginal care system can help restore that balance and reduce the number of UTIs in women who have had recurrent infections.

To participate in this study, women need to be post-menopausal (meaning it has been more than a year since their last period) and generally healthy, even if they have well-managed chronic conditions. They should have experienced at least two UTIs in the past six months or three in the past year, with at least one confirmed by lab tests. Women with certain health issues or those who have had recent medical procedures may not be eligible. If you join the trial, you can expect to use the vaginal care system and share your experiences with the researchers to help improve care for women facing this issue.

Gender

FEMALE

Eligibility criteria

• 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.