RECRUITING

Vaginal Care System for Menopausal Women With Urinary Tract Infections

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-07-10
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05573334

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.

Ages Eligible for Study:Not specified to 89 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 1. Immunosuppressed
  2. 2. Known allergies to aloe vera or to other components of BioNourish®, Balance, or BiopHresh®
  3. 3. Known vaginal infection other than bacterial vaginosis (BV) or yeast infection at time of screening
  4. 4. Women who have needed changes to medical intervention or in-office procedures in the last 3 months
  5. 5. Women who wear a pessary
  6. 6. Women who use catheters regularly
  7. 7. Women with an obstruction or neurogenic bladder causing incomplete bladder emptying.

Contacts and Locations

Study Contact

Shanya San
CONTACT
541-658-2610
shanya@vaginalbiomescience.com

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Vaginal Biome Science

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-10
Study Completion Date2025-09

Study Record Updates

Study Start Date2023-07-10
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Recurrent urinary tract infection
  • Vaginal microbiome
  • Probiotic
  • Lactobacillus

Additional Relevant MeSH Terms

  • Urinary Tract Infections
  • Vaginal Flora Imbalance