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Antibiotic-Free UTI shield after BOTOX-A? a new trial tests methenamine

NCT ID NCT06953271

Prevention Sponsor: Women and Infants Hospital of Rhode Island Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests whether methenamine hippurate, a non-antibiotic antiseptic, can prevent urinary tract infections (UTIs) as effectively as standard antibiotics in women receiving BOTOX-A injections for overactive bladder. Participants will be randomly assigned to take either methenamine or a typical antibiotic for three days after the procedure. The study tracks UTI rates within 30 days and compares patient satisfaction with each medication.

What this could mean

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

Active substance
Methenamine hippurate (an antiseptic) compared to typical oral antibiotics (like nitrofurantoin) taken after BOTOX-A injections.
What this could lead to
If methenamine works as well as antibiotics, it could offer a non-antibiotic option to prevent UTIs after BOTOX-A, reducing antibiotic overuse and resistance.
What could go wrong
This is a single trial with 164 women, and methenamine may not be as effective as antibiotics. Also, it only applies to this specific procedure and population.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 164 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

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

18 years and older

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: * 18 years of age or older * undergoing intradetrusor BOTOX-A injections in the office setting for overactive bladder Exclusion Criteria: * cisgender male individuals * neurogenic reasons for bladder symptoms (i.e. spinal cord injury, multiple sclerosis, etc.) * known allergy and/or contraindication to methenamine hippurate * currently already taking methenamine hippurate at the time of the procedure * taking antibiotics for any reason on the day of their BOTOX-A procedure * positive UTI at time of procedure (positive dip at time of procedure) * history of bladder cancer * history of pelvic radiation * surgically altered detrusor muscle * pre-procedural need for catheterization * diagnosis of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) * pregnant or lactating individuals

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Conditions

The condition(s) this trial relates to.

disease overactive bladder urinary tract infection prevention target

As listed by the trial registrant

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

Overactive bladder (OAB) Urinary tract infection (diagnosis)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Women & Infants Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

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