Clinical trial NCT05397782: Effects of Flourish on Recurrent Urinary Tract Infection
Official title: Pilot Study: Effects of Flourish Vaginal Care System in Women With Recurrent Symptomatic Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: vaginal microbiome
microbiome
probiotic
lactobacillus
vulvovaginal symptoms questionnaire
vaginal pH
Lead sponsor: Vaginal Biome Science
Sponsor class: OTHER
Collaborators: name: Urology Associates, P.C., Tennessee
First posted: 2022-05-31
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vaginal Microbiome
timeFrame: Baseline to 3 months
measure: Vaginal Microbiome
timeFrame: Baseline to 6 months
measure: Vaginal Microbiome
timeFrame: 3 months to 6 months
measure: UTI recurrence
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Associations between microbes and UTI
timeFrame: Baseline to 6 months.
measure: Vaginal pH
timeFrame: Baseline to 6 months
measure: Vaginal pH
timeFrame: Baseline to 3 months
measure: Vaginal pH
timeFrame: 3 months to 6 months
measure: Vulvovaginal symptoms questionnaire (VSQ) + addendum
timeFrame: Baseline
measure: Vulvovaginal symptoms questionnaire (VSQ) + addendum
timeFrame: 3 months
measure: Vulvovaginal symptoms questionnaire (VSQ) + addendum
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: WISH A Place for Women
state: Tennessee
Study officials:
affiliation: Women's Institute of Sexual Health / Urology Associates
name: Brooke Faught, DNP
role: PRINCIPAL_INVESTIGATOR
References: