Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05397782
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2022-05-26
Brief Title:
Effects of Flourish on Recurrent Urinary Tract Infection
Sponsor:
Vaginal Biome Science
Organization:
Vaginal Biome Science
Study Overview
Official Title:
Pilot Study Effects of Flourish Vaginal Care System in Women With Recurrent Symptomatic Urinary Tract Infections
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None