Effects of Flourish on Recurrent Urinary Tract Infection

Urinary Tract Infections Clinical Trial

Official title:

Pilot Study: Effects of Flourish Vaginal Care System in Women With Recurrent Symptomatic Urinary Tract Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05397782
• Other study ID #: rUTI0522
• Status: Completed
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: February 21, 2024

Study information

• Verified date: March 2024
• Source: Vaginal Biome Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 21, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Tract Infections

Intervention

Device:
• BioNourish, 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.

Locations

Country	Name	City	State
United States	WISH A Place for Women	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vaginal Biome Science	Urology Associates, P.C., Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal Microbiome	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).	Baseline to 3 months
Primary	Vaginal Microbiome	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).	Baseline to 6 months
Primary	Vaginal Microbiome	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).	3 months to 6 months
Primary	UTI recurrence	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).	Baseline to 6 months
Secondary	Associations between microbes and UTI	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.	Baseline to 6 months.
Secondary	Vaginal pH	Vaginal pH will be tested by pH strip.	Baseline to 6 months
Secondary	Vaginal pH	Vaginal pH will be tested by pH strip.	Baseline to 3 months
Secondary	Vaginal pH	Vaginal pH will be tested by pH strip.	3 months to 6 months
Secondary	Vulvovaginal symptoms questionnaire (VSQ) + addendum	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.	Baseline
Secondary	Vulvovaginal symptoms questionnaire (VSQ) + addendum	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.	3 months
Secondary	Vulvovaginal symptoms questionnaire (VSQ) + addendum	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.	6 months