NCT05397782

Effects of Flourish on Recurrent Urinary Tract Infection

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Vaginal Biome Science · Academic / Other
• Sex: Female
• Age: 18 Years – 52 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-26
• Primary completion: 2024-02-21
• Completion: 2024-02-21
• First posted: 2022-05-31
• Last updated: 2024-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study