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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

DRUGOFLOCET 200 mg
DRUG5 ml
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