Overactive bladder (OAB) and/or detrusor overactivity (DO) in multiple sclerosis (MS) MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: BOTOX
Product Name: botulinum toxin A
Pharmaceutical Form: Powder and solution for solution for injection
Trade Name: BOTOX
Product Name: botulinum toxin A
Pharmaceutical Form: Powder a
Sponsors
Centre Hospitalier Universitaire de Lille
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Female and male over 18 years-old -MS or SCI (traumatic or non-traumatic) -Refractory OAB and/or DO (failure, intolerance or contra-indication to anti-muscarinic therapy) -Treated with intra-vesical botulinum toxin A injections having proved efficacy -CISC as the exclusive bladder management -AB on pre-operative urine analysis (performed 10 days (+/- 2 days) before intra-vesical BoNTA injections) -Exclusion of morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic UTI. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 226
Exclusion criteria
Exclusion criteria: - Having already participated to the study - Augmentation cystoplasty - Bladder compliance disorders (<20 mL/cmH2O) - Ongoing cyclic antibiotic therapy - Ongoing corticosteroid therapy - Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion (MS patients) - Antibiotic therapy in the month before inclusion - 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 - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of “antibiotic saving strategy” compared to peri-operative antibiotic strategy (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injections in the management of asymptomatic bacteriuria (AB) among multiple sclerosis (MS) and spinal cord injured (SCI) patients undergoing clean intermittent self-catheterization (CISC). ;Secondary Objective: In the management of AB in the context of intra-vesical BoNTA injections, in MS and SCI patients undergoing CISC: - To compare between antibiotic saving strategy and peri-operative antibiotic strategy the others safety and efficacy outcomes. - To study the risk factors associated with post-injection symptomatic UTI. - To carry out an ad-hoc health-economic analysis aiming to compare current recommendations (peri-operative antibiotic strategy) with the “antibiotic saving strategy”. ;Primary end point(s): Rate of patients with symptomatic UTI occurring within the 6 weeks following intra-vesical BoNTA injections.;Timepoint(s) of evaluation of this end point: 6 weeks following | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: -Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections. -Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections. -Rate of patients with symptomatic UTI within the 6 weeks following BoNTA injections finally needing the administration of an antibiotic therapy. -Rate of patients with complication (other than symptomatic UTI) related to BoNTA injections occurring within the 6 weeks following the injections. -Rate of patients with complication not related to BoNTA injections occurring within the 6 weeks following the injections. -Rate of patients with admission to an emergency unit related to BoNTA injections occurring within the 6 weeks following the injections. -Rate of patients with admission to an emergency unit not related to BoNTA occurring within the 6 weeks following the injections. -Rate of patients with admission in a non-scheduled hospitalization related to BoNTA injections occurring within the 6 weeks following the injections. -Rate of patients with admission in a non-scheduled hospitalization not related to BoNTA injections occurring within the 6 weeks following the injections. Efficacy: -Maximal cystometric capacity (MCC) evaluated 6 weeks after BoNTA injections. -Rate of patients with DO (non-voiding detrusor contractions during feeling phase) evaluated 6 weeks after BoNTA injections. oIf DO: volume at the first uninhibited detrusor contraction oIf DO: maximal detrusor pressure -Number of CISC per day evaluated 6 weeks after BoNTA injections. -Number of urgency episodes evaluated 6 weeks after BoNTA injections. -Number of urinary incontinence episodes per day evaluated 6 weeks after BoNTA injections. -Functional bladder capacity evaluated 6 weeks after BoNTA injections. Risk factors associated with post-operative symptomatic UTI: -Diabetes mellitus -History of recurrent symptomatic UTI in the year pre | — |
Countries
France
Outcome results
None listed