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Botox for bladder: scientists probe hidden microbiome link

NCT ID NCT07025044

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at how Botox injections for overactive bladder affect the community of bacteria in the urinary tract of postmenopausal women. Researchers will collect urine samples before and after treatment to see if changes in the microbiome relate to treatment success or side effects like urinary tract infections. The goal is to learn more about who benefits most from Botox and why some women develop infections afterward.

What this could mean

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

Active substance
onabotulinum toxin type A (Botox)
What this could lead to
If successful, this study could help doctors understand why some women get urinary tract infections after Botox treatment for overactive bladder.
What could go wrong
This is a small, early feasibility study with only 40 participants, so results may not apply to all women. It is designed to test methods, not to prove treatment effectiveness.

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.

Participants

About 40 people

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

Started

Sep 2025

Expected to finish

Jun 2026

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.

Who is studied

Subjects from the patient population treated at a MedStar Urogynecology clinics located across DC, Maryland and Virginia will be recruited and eligible for enrollment. Potential subjects will be identified both via provider referral and through electronic medical record review to identify patients scheduled for onabotulinum toxin type A injection.

Ages

55 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: * Natal female \> 55 years old * English-speaking * Scheduled to undergo onabotulinum toxin type A for treatment of OAB * No menses for \>1 year if uterus in situ * Planning one dose nitrofurantoin for antibiotic prophylaxis at time of onabotulinum toxin type A injection per clinic protocol Exclusion Criteria: * Diagnosis of painful bladder syndrome * Current symptomatic or clinically-suspected UTI within 30 days prior to onabotulinum toxin type A injection procedure\* * Systemic antibiotic exposure within 30 days\^ * Prophylactic antibiotic treatment for recurrent UTI within the last 12 months * Current systemic immunosuppressive therapy (i.e. prednisone or immunomodulators) immunotherapy, chemotherapy or radiation treatment * Prior pelvic radiation * Indwelling catheter or intermittent catheterization

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Conditions

The condition(s) this trial relates to.

overactive bladder Urinary Incontinence, Urge

As listed by the trial registrant

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

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

  • MedStar Urogynecology Clinic

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

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