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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.

Must not have

Women who use catheters regularly

Women who have needed changes to medical intervention or in-office procedures in the last 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 and 6 months in a repeated measures assessment.

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use a catheter.

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I have had changes in my treatment or procedures in the last 3 months.

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I do not have a vaginal infection other than BV or yeast.

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I am allergic to aloe vera or ingredients in BioNourish®, Balance, or BiopHresh®.

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I have bladder issues that prevent it from emptying completely.

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My immune system is weakened.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 and 6 months in a repeated measures assessment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vagina

Body Weight Changes

Frequency of UTI

Secondary study objectives

Urinary tract infection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met