Assess the Efficacy of OM-89 vs Placebo in Reducing Antibiotic Consumption Associated With the Treatment of Urinary Tract Infections in Patients With Neurogenic Bladder

Exclusion Criteria

• •Person who is not affiliated with the national health insurance system
• •Person subject to a measure of legal protection (guardianship, tutorship)
• •Person subject to a court order
• •Adults unable to express consent
• •Patients using a urinary drainage method other than CIC
• •Patients with urinary lithiasis at the time of inclusion (assessed by renal imaging in the previous year as part of routine management for patients with a history(s) of lithiasis or within 3 years for patients with no history)
• •Presence of an endo-urinary device (urinary prosthesis, ureteral stent)
• •Enterocystoplasty or irradiated bladder (past or present)
• •Known allergy or previous intolerance to the active substance or one of the excipients of OM-89 or placebo
• •Patient requiring ongoing or short-term prolonged antibiotic therapy (e.g. infected bedsore, etc.)
• •Patient treated with bacterial lysates (including OM-89) in the 6 months prior to randomisation
• •Unable or unwilling to stop prophylactic antibiotic therapy prior to randomisation
• •Patient with a known malignant tumour or neoplasia
• •Patient with an autoimmune disease
• •Patient treated with long-term or bolus corticosteroids, anti-CD20 and anti-rejection therapy in the 6 months prior to screening
• •Patient currently taking part in another study on an investigational device or drug related to urinary tract infections, or who has received another investigational treatment in the 30 days prior to screening.
• •Patient unable to collect information in a daily diary.
• •Patient unable to understand follow-up by telephone.
• •Patients planning to move to another residence in the year following randomisation
• •Non-menopausal women who are not surgically sterile (bilateral oophorectomy or hysterectomy) AND pregnant, breast-feeding who are declare that they are planning to conceive at inclusion, or not using effective\* contraception.