Botox for bladder: scientists probe hidden microbiome link
NCT ID NCT07025044
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
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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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
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55 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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MedStar Urogynecology Clinic
RECRUITINGWashington D.C., District of Columbia, 20010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A patch-like device zaps a leg nerve to calm an overactive bladder
- Can a nerve stimulation device outdo pelvic floor exercises for overactive bladder?
- Nerve zaps for bladder troubles: a hidden effect on heart rhythms?
- Shocking the saphenous nerve: a new way to calm an overactive bladder?
- Antibiotic-Free UTI shield after BOTOX-A? a new trial tests methenamine
- Blood test may predict bladder drug success