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Could a vaginal gel cut recurrent UTIs in menopause?

NCT ID NCT05573334

Disease control Sponsor: Vaginal Biome Science Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether an over-the-counter vaginal moisturizing gel, called BioNourish, could reduce recurrent urinary tract infections (UTIs) in menopausal women. The idea is that the gel helps restore a healthy vaginal microbiome, which may protect against UTIs. Eight post-menopausal women with a history of repeat UTIs used the product for six months, and researchers tracked changes in vaginal bacteria, pH, and UTI frequency. Because it's a very small pilot, the results are preliminary and need larger studies to confirm.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BioNourish vaginal moisturizing gel (device)
What this could lead to
If it works, this could offer a non-hormonal, over-the-counter option to help menopausal women reduce recurrent urinary tract infections.
What could go wrong
This is a very small pilot study with only 8 participants, so results may not apply widely. The device is already on the market, but its effect on UTI frequency is still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

8 people

The number who actually took part.

Started

Jul 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 89 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Post-menopausal women who are in generally good health, including those with chronic conditions adequately controlled by common medications. Post-menopausal is defined as \>12 months since last menstrual period. Menopause may be natural or induced due to surgical or medical intervention. 2. 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. Exclusion Criteria: 1. Immunosuppressed 2. Known allergies to aloe vera or to other components of BioNourish®, Balance, or BiopHresh® 3. Known vaginal infection other than bacterial vaginosis (BV) or yeast infection at time of screening 4. Women who have needed changes to medical intervention or in-office procedures in the last 3 months 5. Women who wear a pessary 6. Women who use catheters regularly 7. Women with an obstruction or neurogenic bladder causing incomplete bladder emptying.

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Conditions

The condition(s) this trial relates to.

urinary tract infection urinary tract infections, recurrent, susceptibility to

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary tract infections Vaginal flora imbalance

Contacts and locations

Locations

  • Center for Urogynecology & Pelvic Reconstructive Surgery

    Newark, Delaware, 19713, United States

More trials for these conditions

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