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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515107-19-00
Acronym
DRI_2020/03
Enrollment
526
Registered
2025-11-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

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).

Interventions

DRUGClamoxyl 1 g
DRUGcomprimés dispersibles
DRUGOFLOCET 200 mg
DRUG5 ml
DRUGROCEPHINE 1 g/10 ml
DRUGpoudre et solvant pour solution injectable (IV)
DRUGTAVANIC 500 mg
DRUG5 mg
DRUGSELEXID 200 mg
DRUGcomprimé pelliculé
DRUGDELPRIM 300 mg comprimé sécable
DRUGCIFLOX 500 mg
DRUGBACTRIM FORTE
DRUGcomprimé
DRUGMONURIL 3 g
DRUGOROKEN 200 mg

Sponsors

Centre Hospitalier Universitaire De Lille
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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 injectio

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026