Your session is about to expire
← Back to Search
Behavioural Intervention
Vaginal Care System for Urinary Tract Infection
N/A
Recruiting
Led By Helen Cohen, MS, RN, WHNP-BC
Research Sponsored by Vaginal Biome Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 and 6 months in a repeated measures assessment.
Awards & highlights
Study Summary
This trial will study if improving the vaginal microbiome of menopausal women with an over-the-counter system can reduce risk of recurrent UTIs due to hormonal changes.
Who is the study for?
This trial is for post-menopausal women in good health who have had at least 2 UTIs in the last six months or 3 in the past year. They must be over 12 months since their last period, which can be due to natural or medical reasons. Women with immune issues, allergies to BioNourish® ingredients, recent medical changes, pessary use, catheter reliance, or certain bladder conditions cannot join.Check my eligibility
What is being tested?
The study tests if an over-the-counter vaginal hygiene system called BioNourish can help reduce recurrent urinary tract infections by improving the vaginal microbiome in menopausal women.See study design
What are the potential side effects?
Potential side effects are not detailed but may include reactions related to known allergies to aloe vera or other components of BioNourish®, such as skin irritation or discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least 2 UTIs in the last 6 months or 3 in the last year, with one confirmed by a lab test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 and 6 months in a repeated measures assessment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 and 6 months in a repeated measures assessment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Vagina
Body Weight Changes
Frequency of UTI
Secondary outcome measures
Urinary tract infection
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Flourish HECExperimental Treatment1 Intervention
The experimental (or intervention) arm uses 3 products in a vaginal hygiene system in addition to any routine care they would normally receive. These 3 products are a vulvar wash (for external use), a vaginal moisturizing gel (BioNourish), and a vaginal homeopathic suppository with probiotics.
The vulvar wash is used daily or as often as a participant bathes/showers. The vaginal moisturizing gel, which is formulated to match healthy vaginal secretions for pH, osmolality, and lactic acid levels, is used every day before bed.
The vaginal homeopathic suppository with probiotics is used every 3rd day before bed. This suppository contains native vaginal probiotic species associated with healthy vaginal microbiomes.
Group II: Routine CareActive Control1 Intervention
The Routine Care arm is a control group receiving no study intervention. They receive whatever routine care is standard for the study PI's treatment of usual recurrent UTI patients, including antibiotics for active infections, estrogen and supplements for prevention of infection.
Find a Location
Who is running the clinical trial?
Vaginal Biome ScienceLead Sponsor
8 Previous Clinical Trials
134 Total Patients Enrolled
ChristianaCareOTHER
3 Previous Clinical Trials
10,640 Total Patients Enrolled
Sexual Health and Wellness InstituteLead Sponsor
8 Previous Clinical Trials
134 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had at least 2 UTIs in the last 6 months or 3 in the last year, with one confirmed by a lab test.I regularly use a catheter.I have had changes in my treatment or procedures in the last 3 months.Women who use a pessary.I do not have a vaginal infection other than BV or yeast.I am allergic to aloe vera or ingredients in BioNourish®, Balance, or BiopHresh®.I have bladder issues that prevent it from emptying completely.I am a post-menopausal woman in good health, even with controlled chronic conditions.My immune system is weakened.
Research Study Groups:
This trial has the following groups:- Group 1: Routine Care
- Group 2: Flourish HEC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical experiment currently have any available openings for participants?
"According to clinicaltrials.gov, this medical study is no longer searching for participants as the last reported update was on October 6th 2022. However, there are currently 793 other trials that require volunteers."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger