DRI_2020/03
What it found
No result yet.
What was tested
Treatment tested
- Levofloxacin anhydrous
- Sulfamethoxazole
Bacterial dihydropteroate synthase inhibitor
- Amdinocillin pivoxil
Bacterial penicillin-binding protein 2 inhibitor
- Aztreonam
Bacterial penicillin-binding protein inhibitor
- Cefixime
Bacterial penicillin-binding protein inhibitor
- Nitrofurantoin
DNA inhibitor
- Trimethoprim
Bacterial dihydrofolate reductase inhibitor
- Ciprofloxacin
Bacterial DNA gyrase inhibitor|Topoisomerase IV inhibitor
- Amoxicillin
Bacterial penicillin-binding protein inhibitor
- Ceftriaxone
- Fosfomycin
- Ofloxacin
Bacterial DNA gyrase inhibitor
- Lidocaine
Sodium channel alpha subunit blocker
What it measured
Main measures
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
Other measures (15)
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.
SafetyRate of patients with adverse events not related to** intra-vesical BoNTA injection occurring within the 6 weeks following the injection
SafetyRate 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).
Who could take part
MS (type not specified) · 18 and over
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 - 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 - Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on. - Immunocompromised patients - Patient without easy access to internet within 6 weeks of the injection - Surgical procedure in the 3 months before and the 6 weeks following inclusion - Symptomatic UTI at the time of inclusion - 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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Loading reviews and guidelines…
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History
Started
Sept 2025
Finished
Sept 2027
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