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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceNot yet recruiting
Raymond-Poincare Hospital
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GarchesFranceNot yet recruiting
Centre Hospitalier Universitaire De Lille
Coordinator of this site? Confirm its status
Lille CedexFranceNot yet recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceNot yet recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceNot yet recruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Paris Cedex 13FranceNot yet recruiting
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
Pierre-BéniteFranceNot yet recruiting
Centre Hospitalier Universitaire De Rennes
Coordinator of this site? Confirm its status
Rennes Cedex 9FranceNot yet recruiting
Centre Hospitalier Universitaire De Toulouse
Coordinator of this site? Confirm its status
Toulouse Cedex 9FranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.