AuthorisedTherapeutic confirmatory (Phase III)Interventional

ANTIBIOBONTA - Assessment of the interest of a peri-operative antibiotic strategy applied to patients with asymptomatic bacteriuria undergoing intra-vesical botulinum toxin A injections

This research is investigating if a special plan of antibiotics given around the time of bladder botulinum toxin A injections can help stop urine infections. It's for adult patients aged 18 and over who have overactive bladder due to multiple sclerosis (MS) or a spinal cord injury. These patients also have bacteria in their urine but don't currently have any infection symptoms, which is called 'asymptomatic bacteriuria'. The study aims to find out how many people get a urine infection in the six weeks after their injection and whether this antibiotic strategy makes a difference. It's an important step to improve care for people with these conditions.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Lille

Enrolment target

526

Start

10 Nov 2025

Patients (male or female) ≥18 years old with Detrusor overactivity (DO) in multiple sclerosis (MS) or spinal cord injured (SCI).

What is this study about?

This study, called ANTIBIOBONTA, is designed to look closely at how we can prevent urinary tract infections (UTIs) in certain patients. We're focusing on adults who have an overactive bladder because of conditions like multiple sclerosis (MS) or a spinal cord injury. These patients sometimes have a common procedure where a medicine called botulinum toxin A (often known by brand names like Botox) is injected into their bladder to help control their bladder problems.

A key challenge some of these patients face is that they might have bacteria in their urine without actually feeling sick or having UTI symptoms – this is called 'asymptomatic bacteriuria'. Historically, doctors might have given antibiotics around the time of the injection to try and prevent an infection, but we need more clear evidence to know the best approach. This study is testing a specific plan of antibiotics given before and after the bladder injection to see if it reduces the number of patients who develop a full-blown, symptomatic UTI in the following six weeks.

By carefully tracking how many patients get UTIs and how severe they are, as well as looking at any other side effects, this research aims to find the most effective and safest way to manage these patients. The ultimate goal is to improve the comfort and health of people undergoing these important bladder treatments.

Key takeaways

It's about preventing urine infections after bladder injections.
Specifically for adults with MS or spinal cord injury with overactive bladders.
It focuses on patients who have bacteria in their urine without symptoms.
The study tests an antibiotic plan given around the time of the injection.
It aims to make the bladder injection procedure safer.

Who may be eligible?

This study is looking for adults aged 18 and over, both men and women.

To be considered for this study, you must have an overactive bladder due to either multiple sclerosis (MS) or a spinal cord injury.

Crucially, you would also need to have bacteria found in your urine, but without any symptoms of a urinary tract infection. This condition is sometimes called 'asymptomatic bacteriuria'.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have an overactive bladder due to multiple sclerosis or a spinal cord injury?
Have you been told you have bacteria in your urine, but don't currently have UTI symptoms?
Are you due to have a botulinum toxin A injection into your bladder?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would receive specific antibiotics around the time of your bladder botulinum toxin A injection. The study will track whether you develop a urine infection in the six weeks following your injection. This involves monitoring your symptoms closely and potentially providing urine samples. There will be planned check-ups to assess your bladder function and general well-being after the injection. The total duration of active follow-up for the main goals of the study is six weeks after your bladder injection.

Potential risks and benefits

Participating in this study might offer the benefit of receiving an antibiotic strategy designed to reduce your risk of post-procedure urine infections. However, like all medications, the antibiotics used in the study have potential side effects, such as allergic reactions or stomach upset. There's also a chance the antibiotic strategy might not prevent a UTI. You are free to withdraw from the study at any time without giving a reason, and this decision will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'asymptomatic bacteriuria'?

It means you have bacteria in your urine, but you don't feel sick or have any symptoms of a urine infection.

What is botulinum toxin A injection for the bladder?

It's a treatment where a small amount of medicine is injected into your bladder wall to help with overactive bladder symptoms, such as urgency and leakage.

What type of antibiotics are being used?

The study involves several common antibiotics that doctors prescribe, some taken by mouth and others given as an injection, depending on the specific plan being studied.

How long will I be monitored for?

The main part of the study will follow you closely for six weeks after your bladder injection to check for any urine infections or other issues.

Will this study cure my bladder problems?

This study isn't designed to cure your bladder problems, but to find the best way to prevent infections after a common treatment for them.