Urinary Tract Infections
Conditions
Keywords
vaginal microbiome, microbiome, probiotic, lactobacillus, vulvovaginal symptoms questionnaire, vaginal pH
Brief summary
An over-the-counter vaginal care system is being tested to see if it may be effective in preventing recurrence of symptomatic urinary tract infection (UTI) in women who have had multiple UTIs within the past year.
Detailed description
Women who have a urinary tract infection (UTI) may experience a recurrence within weeks or months of treatment. Some women may experience 8 or more UTIs in a single year, leading to multiple rounds of antibiotics, with the individual risks to organs and risk of antibiotic resistance growing with each round. Alternative methods for prevention of recurrent UTI is therefore desirable. This study will test whether women who use a commercially available, over-the-counter vaginal care system may be able to reduce recurrences of UTI over a six-month period. This is a pilot study designed to determine whether a larger randomized controlled trial in the future would be justified.
Interventions
DEVICEBioNourish, a component of Flourish HEC
BioNourish, one of three parts of the Flourish HEC system, is a vaginal moisturizing gel - a Class II medical device with FDA 510k clearance obtained in 2020.
Sponsors
Urology Associates, P.C., Tennessee
Vaginal Biome Science
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A single group of women with recurrent symptomatic UTI will be studied longitudinally while using the intervention system. Results will be compared with historical controls.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
No
Inclusion criteria
1. Premenopausal cis women aged 18-52 who are in generally good health 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. Pregnant or trying to become pregnant 2. Lactating 3. Immunosuppressed 4. Known allergies to aloe vera or to other components of Restore®, Balance or BiopHresh® 5. Known vaginal infection other than BV or yeast infection at time of screening 6. Women who have needed changes to medical intervention or in-office procedures in the last 3 months 7. Women using vaginal acidifying agents or spermicides for contraception 8. Women who wear a pessary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Microbiome | Baseline to 3 months | The vaginal microbiome will be assessed using next-generation sequencing (NGS) technology to assign the biome to one of 5 community state types (CST). The outcome will examine whether the vaginal microbiome changes from an unhealthy one (IV or III) to a healthy one (I, II, or V). |
| UTI recurrence | Baseline to 6 months | Frequency of symptomatic UTI over study duration will be assessed (number of occurrences per person). UTI will be diagnosed when one or more symptoms is present (urinary urgency, frequency, sense of burning, pelvic pain, fever, flank pain) along with one or more confirming lab tests (positive culture, urine nitrites or leukocytes). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Associations between microbes and UTI | Baseline to 6 months. | Using the NGS sequencing data from primary outcomes 1, 2, and 3, statistical modeling will be used to determine if the presence of specific individual bacteria or combinations of two or more species are associated with increased frequency of UTI. |
| Vaginal pH | Baseline to 6 months | Vaginal pH will be tested by pH strip. |
| Vulvovaginal symptoms questionnaire (VSQ) + addendum | Baseline | Vulvovaginal symptoms will be assessed by questionnaire. Both the validated VSQ and additional questions not previously validated will be used. Most questions will be asked using a 4-point Likert scale (0=not at all, 4 = all the time), except those which are binary in nature. |
Countries
United States
Outcome results
None listed