Not yet recruitingPhase 3MS (type not specified)2024-515107-19-00

What it found

Still running

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.

    Safety
  • Rate of patients with adverse events not related to** intra-vesical BoNTA injection occurring within the 6 weeks following the injection

    Safety
  • 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).

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 registry

About 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.

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Related trials

History

    1. Started

      Sept 2025

    2. Finished

      Sept 2027

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