ANTIBIOBONTA - Assessment of the interest of a peri-operative antibiotic strategy applied to patients with asymptomatic bacteriuria undergoing intra-vesical botulinum toxin A injections
Key facts
- Where
- Bordeaux, Garches, Lille Cedex, Nantes, Paris, Paris Cedex 13, Pierre-Bénite, Rennes Cedex 9, and Toulouse Cedex 9, FranceSee the 9 sites
- Phase
- Phase 3
Where in France
- Centre hospitalier Universitaire de BordeauxBordeaux, FranceNot yet recruiting
- Raymond-Poincare HospitalGarches, FranceNot yet recruiting
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceNot yet recruiting
- Centre Hospitalier Universitaire de NantesNantes, FranceNot yet recruiting
- Assistance Publique Hopitaux de ParisParis, FranceNot yet recruiting
- Assistance Publique Hopitaux De ParisParis Cedex 13, FranceNot yet recruiting
- Hospices Civils de LyonPierre-Bénite, FranceNot yet recruiting
- Centre Hospitalier Universitaire De RennesRennes Cedex 9, FranceNot yet recruiting
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire De Lille
- Trial code
- NCT05534399EU 2024-515107-19-00
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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; 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.