AZTREONAM for Detrusor overactivity | Multiple sclerosis | Spinal cord injury

Inclusion criteria

• {"criterion_text":"- Female and male over 18 years-old\n- Multiple Sclerosis or Spinal Cord Injury (traumatic or non-traumatic)\n- Clean Intermittent Self-Catheterization as the exclusive bladder management\n- Refractory Detrusor Overactivity leading to urinary incontinence (failure, intolerance or contra-indication to anti-muscarinic therapy)\n- Treated with intra-vesical BoNTA injections having proved efficacy\n- Asymptomatic Bacteriuria (bacteriuria threshold ≥ 10² CFU/mL) on pre-operative urine analysis (performed 5 days (+/- 2 days) before intra-vesical BoNTA injections)\n- With a personal and functional e-mail address, a quasi-permanent Internet connection and a mobile phone."}

Exclusion criteria

• {"criterion_text":"- Contra-Indication to botulinum toxin a, and excipients included in study drugs\n- Ongoing cyclic antibiotic therapy\n- Ongoing corticosteroid therapy\n- Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion\n- Antibiotic therapy in the month before inclusion\n- Absence of use of any recognized contraceptive method (e.g. hormonal, barrier, IUD, sterilization) or of consistent sexual abstinence\n- Individuals especially in need of protection\n- No informed consent\n- Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on.\n- Immunocompromised patients\n- Patient without easy access to internet within 6 weeks of the injection\n- Surgical procedure in the 3 months before and the 6 weeks following inclusion\n- Symptomatic UTI at the time of inclusion\n- Associated neurologic disease\n- • Pregnancy or breast feeding\n- Having already participated to the study\n- Augmentation cystoplasty\n- Bladder compliance disorders (<20 mL/cmH2O)\n- Morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic UTI"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Occurrence of symptomatic UTI within 6 weeks after intra-vesical BoNTA injection; symptomatic UTI defined per NIDRR (1992) as significant bacteriuria with tissue invasion and resultant tissue response with signs and/or symptoms of UTI."}

Secondary endpoints

• {"endpoint_text":"- Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following intra-vesical BoNTA injection.","definition_or_measurement_approach":"Occurrence of febrile symptomatic UTI within 6 weeks after injection."}
• {"endpoint_text":"- Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following intra-vesical BoNTA injection.","definition_or_measurement_approach":"Occurrence of non-febrile symptomatic UTI within 6 weeks after injection."}
• {"endpoint_text":"- Rate of patients with symptomatic UTI within the 6 weeks following intra-vesical BoNTA injection finally needing the administration of an antibiotic therapy.","definition_or_measurement_approach":"Occurrence of symptomatic UTI within 6 weeks that required antibiotic treatment."}
• {"endpoint_text":"- Rate of patients with adverse events (other than symptomatic UTI) related to* intra-vesical BoNTA injections occurring within the 6 weeks following the injection.","definition_or_measurement_approach":"Rate of adverse events related to BoNTA within 6 weeks after injection."}
• {"endpoint_text":"- Rate of patients with adverse events not related to** intra-vesical BoNTA injection occurring within the 6 weeks following the injection","definition_or_measurement_approach":"Rate of adverse events not related to BoNTA within 6 weeks after injection."}
• {"endpoint_text":"- Rate of patients with admission to an emergency unit related to* intra-vesical BoNTA injection occurring within the 6 weeks following the injection.","definition_or_measurement_approach":"Rate of ED admissions related to BoNTA within 6 weeks after injection."}
• {"endpoint_text":"- Rate of patients with admission to an emergency unit not related** to intra-vesical BoNTA injection occurring within the 6 weeks following the injection","definition_or_measurement_approach":"Rate of ED admissions not related to BoNTA within 6 weeks after injection."}
• {"endpoint_text":"- Rate of patients with admission in a non-scheduled hospitalization related to* intra-vesical BoNTA injection occurring within the 6 weeks following the injection","definition_or_measurement_approach":"Rate of unscheduled hospitalizations related to BoNTA within 6 weeks after injection."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Rate of unscheduled hospitalizations not related to BoNTA within 6 weeks after injection."}
• {"endpoint_text":"- Maximal cystometric capacity (MCC) evaluated 6 weeks after BoNTA injection (UDS).","definition_or_measurement_approach":"MCC measured by urodynamic study (UDS) at 6 weeks post-injection."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"DO assessed by UDS at 6 weeks; if DO present record first uninhibited contraction volume (mL) and maximal detrusor pressure (cmH2O)."}
• {"endpoint_text":"- Number of CISC per day evaluated 6 weeks after BoNTA injection (3-day bladder diary).","definition_or_measurement_approach":"Number of clean intermittent self-catheterizations per day measured by 3-day bladder diary at 6 weeks."}
• {"endpoint_text":"- Number of urgency episodes evaluated 6 weeks after BoNTA injection (3-day bladder diary).","definition_or_measurement_approach":"Number of urgency episodes measured by 3-day bladder diary at 6 weeks."}
• {"endpoint_text":"- Number of urinary incontinence episodes per day evaluated 6 weeks after BoNTA injection (3-day bladder diary).","definition_or_measurement_approach":"Number of urinary incontinence episodes per day measured by 3-day bladder diary at 6 weeks."}
• {"endpoint_text":"- Functional bladder capacity evaluated 6 weeks after BoNTA injection (3-day bladder diary).","definition_or_measurement_approach":"Functional bladder capacity assessed via 3-day bladder diary at 6 weeks."}

France

Earliest CTIS Part Ii Submission Date

22-09-2025

Latest Decision Or Authorization Date

10-11-2025

Processing Time Days

49

Number Of Sites

9

Number Of Participants

526

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Lille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France