Vaginal Care System for Menopausal Women With Urinary Tract Infections

Description

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 Overview

Study Details

Study overview

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.

Effects of Flourish HEC Vaginal Care System in Menopausal Women With Recurrent Urinary Tract Infections

Vaginal Care System for Menopausal Women With Urinary Tract Infections

Condition
Urinary Tract Infections
Intervention / Treatment

-

Contacts and Locations

Newark

Center for Urogynecology & Pelvic Reconstructive Surgery, Newark, Delaware, United States, 19713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

to 89 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vaginal Biome Science,

Helen Cohen, MS, RN, WHNP-BC, PRINCIPAL_INVESTIGATOR, ChristianaCare

Study Record Dates

2025-09