NCT05534399Not yet recruitingPhase 3
ANTIBIOBONTA - Assessment of the interest of a peri-operative antibiotic strategy applied to patients with asymptomatic bacteriuria undergoing intra-vesical botulinum toxin A injections
Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Sept 2026
Brief summary (registry, in English)
To demonstrate the non-inferiority of “antibiotic sparing strategy” compared to “peri-operative antibiotic strategy” (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injection in the management of asymptomatic bacteriuria (AB) among MS and SCI patients undergoing CISC.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 526 (estimated)
- First submitted
- 18 Jul 2025
- Start date
- 1 Sept 2025
- Lead sponsor
- Centre Hospitalier Universitaire De Lille
- Diseases
- Multiple sclerosis
- NCT number
- NCT05534399
- EU CT number
- 2024-515107-19-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 526
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contra-Indication to botulinum toxin a, and excipients included in study drugs
- Ongoing cyclic antibiotic therapy
- Ongoing corticosteroid therapy
- Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion
- Antibiotic therapy in the month before inclusion
- Surgical procedure in the 3 months before and the 6 weeks following inclusion
Other illness
- Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on.
- Associated neurologic disease
- Pregnancy or breast feeding
- Having already participated to the study
- Augmentation cystoplasty
- Bladder compliance disorders (<20 mL/cmH2O)
- Morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic UTI
Other
- Absence of use of any recognized contraceptive method (e.g. hormonal, barrier, IUD, sterilization) or of consistent sexual abstinence
- Individuals especially in need of protection
- No informed consent
- Immunocompromised patients
- Patient without easy access to internet within 6 weeks of the injection
- Symptomatic UTI at the time of inclusion
Who the study is looking for
- Female and male over 18 years-old
- Multiple Sclerosis or Spinal Cord Injury (traumatic or non-traumatic)
- Clean Intermittent Self-Catheterization as the exclusive bladder management
- Refractory Detrusor Overactivity leading to urinary incontinence (failure, intolerance or contra-indication to anti-muscarinic therapy)
- Treated with intra-vesical BoNTA injections having proved efficacy
- Asymptomatic Bacteriuria (bacteriuria threshold ≥ 10² CFU/mL) on pre-operative urine analysis (performed 5 days (+/- 2 days) before intra-vesical BoNTA injections)
- With a personal and functional e-mail address, a quasi-permanent Internet connection and a mobile phone.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Raymond-Poincare Hospital Coordinator of this site? Confirm its status | Garches | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Not yet recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Rennes Coordinator of this site? Confirm its status | Rennes Cedex 9 | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.