Medico-economical Impact of the Brindley Neurosurgical Technique in France (BRINDLEY)
Spinal Cord Injuries, Neurogenic Bladder Disorder, Paraplegia
About this trial
This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Neurogenic bladder, electric stimulation therapy, urinary tract infection, urinary incontinence, spinal cord injuries, spinal nerve roots, nonRandomized Controlled Trials, open Study
Eligibility Criteria
Inclusion Criteria: Patient with a complete suprasacral spinal cord injury proved by a clinical exam (perineal reflex preserved) and MRI. Clinically stable spinal cord injury for at least 6 months (verified by MRI) Patient with an overactive neurogenic bladder (urodynamic testing), incontinence (specific patient diary) and/or risk for the bladder/kidney (intravenous urography, cystography) signed informed consent Exclusion Criteria: Injured sacral medullar centers or injured sacral roots Non contractile bladder Pregnancy or breast feeding Contraindication linked to neurostimulator implantation: unwounded cutaneous lesion, prolonged septic state, blood coagulation deficiency, known allergy to one component of the implanted medical device (silicone, platinum, iridium) Incapacity to receive an informed consent, incapacity to follow all the study schedule, patient not protected by social security
Sites / Locations
- Neurochirurgie A - Hôpital Pellegrin , Place Amélie Raba-Léon
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
1
2
Brindley technique (bladder system)
Reference group