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Could skipping antibiotics before bladder botox be safe? new trial aims to find out

NCT ID NCT05534399

Disease control Sponsor: University Hospital, Lille 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether it is safe to avoid antibiotics before bladder Botox injections in people with multiple sclerosis or spinal cord injury who have bacteria in their urine but no symptoms. About 526 participants will be randomly assigned to receive either antibiotics or no antibiotics around the time of the procedure. The goal is to see if skipping antibiotics leads to more urinary tract infections in the six weeks after the injection.

What this could mean

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

Active substance
antibiotic therapy (or no antibiotic therapy)
What this could lead to
If successful, this could show that many patients can safely avoid antibiotics before bladder Botox injections, reducing antibiotic overuse and side effects.
What could go wrong
This is a relatively small, early-stage trial. It may find that skipping antibiotics increases the risk of symptomatic urinary tract infections, and results may not apply to all patients.

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

About 526 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 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

Anyone

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: * MS or SCI (traumatic or non-traumatic) * Refractory OAB and/or DO (failure, intolerance or contra-indication to anti-muscarinic therapy) * Treated with intra-vesical botulinum toxin A injections having proved efficacy * CISC as the exclusive bladder management * AB on pre-operative urine analysis (performed 10 days (+/- 2 days) before intra-vesical BoNTA injections) * Exclusion of morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic UTI. Exclusion Criteria: * Having already participated to the study * Augmentation cystoplasty * Bladder compliance disorders (\<20 mL/cmH2O) * Ongoing cyclic antibiotic therapy * Ongoing corticosteroid therapy * Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion (MS patients) * Antibiotic therapy in the month before inclusion * Surgical procedure in the 3 months before and the 6 weeks following inclusion * Symptomatic UTI at the time of inclusion * Associated neurologic disease * Pregnancy or breast feeding * Individuals especially in need of protection * No informed consent * Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on * Immunocompromised patients

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Conditions

The condition(s) this trial relates to.

bacteriuria multiple sclerosis spinal cord injury urinary system disorder

As listed by the trial registrant

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

Urinary tract disease

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

  • Hop Claude Huriez Chu Lille

    Lille, 59037, France

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