Vaginal care system for menopausal women with urinary tract infections
Effects of Flourish HEC Vaginal Care System in Menopausal Women With Recurrent Urinary Tract Infections
This study is testing if a new vaginal care system can help post-menopausal women with frequent urinary tract infections by improving their vaginal health without using antibiotics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 89 Years |
| Sex | Female |
| Sponsor | Vaginal Biome Science Academic / other |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT05573334 on ClinicalTrials.gov |
What this trial studies
This study investigates whether an over-the-counter vaginal hygiene system can improve the vaginal microbiome in post-menopausal women, potentially reducing the frequency of recurrent urinary tract infections (UTIs). It focuses on women who have experienced multiple UTIs, as hormonal changes during menopause can disrupt the vaginal flora, leading to increased susceptibility to infections. The intervention involves the use of BioNourish, a product designed to restore healthy vaginal flora. The study aims to provide an alternative to antibiotic treatments, which can have undesirable side effects and contribute to antibiotic resistance.
Who should consider this trial
Good fit: Ideal candidates for this study are post-menopausal women in generally good health with a documented history of recurrent UTIs.
Not a fit: Patients who are immunosuppressed or have known allergies to components of the intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of recurrent UTIs in menopausal women, improving their quality of life.
How similar studies have performed: While the approach of using vaginal microbiome interventions is gaining interest, this specific application is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Newark, Delaware
- Center for Urogynecology & Pelvic Reconstructive Surgery — Newark, Delaware, United States (Recruiting)
Study contacts
- Principal investigator: Helen Cohen, MS, RN, WHNP-BC — ChristianaCare
- Study coordinator: Shanya San
- Email: shanya@vaginalbiomescience.com
- Phone: 541-658-2610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.