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Effects of Flourish on Recurrent Urinary Tract Infection

NCT05397782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-03-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Urology Associates, P.C., Tennessee

    collaborator OTHER

  • Vaginal Biome Science

    lead OTHER

Principal Investigators

  • Brooke Faught, DNP · Women's Institute of Sexual Health / Urology Associates

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2024-02-21
Completion
2024-02-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05397782 on ClinicalTrials.gov