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

Condition studied

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

Investigational medicinal product(s)

Eligibility

Primary endpoint

Rate of patients with symptomatic UTI occurring within the 6 weeks following intra-vesical BoNTA injection. Symptomatic UTI will be defined according to the National Institute on Disability and Rehabilitation Research (NIDRR, 1992) as a significant bacteriuria with tissue invasion and resultant tissue response with signs and/or symptoms of UTI

Endpoint detail

Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following intra-vesical BoNTA injection., Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following intra-vesical BoNTA injection., Rate of patients with symptomatic UTI within the 6 weeks following intra-vesical BoNTA injection finally needing the administration of an antibiotic therapy., Rate of patients with adverse events (other than symptomatic UTI) related to* intra-vesical BoNTA injections occurring within the 6 weeks following the injection., Rate of patients with adverse events not related to** intra-vesical BoNTA injection occurring within the 6 weeks following the injection, Rate of patients with admission to an emergency unit related to* intra-vesical BoNTA injection occurring within the 6 weeks following the injection., Rate of patients with admission to an emergency unit not related** to intra-vesical BoNTA injection occurring within the 6 weeks following the injection, Rate of patients with admission in a non-scheduled hospitalization related to* intra-vesical BoNTA injection occurring within the 6 weeks following the injection, Rate of patients with admission in a non-scheduled hospitalization not related to* intra-vesical BoNTA injection occurring within the 6 weeks following the injection., Maximal cystometric capacity (MCC) evaluated 6 weeks after BoNTA injection (UDS)., Rate of patients with DO (unhibited detrusor contraction(s) occurring during feeling phase) evaluated 6 weeks after BoNTA injection (UDS). o If DO: Volume at the first uninhibited detrusor contraction (ml) o If DO: Maximal detrusor pressure (cmH2O), Number of CISC per day evaluated 6 weeks after BoNTA injection (3-day bladder diary)., Number of urgency episodes evaluated 6 weeks after BoNTA injection (3-day bladder diary)., Number of urinary incontinence episodes per day evaluated 6 weeks after BoNTA injection (3-day bladder diary)., Functional bladder capacity evaluated 6 weeks after BoNTA injection (3-day bladder diary).