Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury

Who can take part

• Age 18 or older
• Must provide and sign the Informed Consent Form prior to any study-related procedures
• Spinal cord injury lesion level above T11 (inclusive)
• SCI graded as AIS- B, C or D
• SCI ≥ 6 months
• Confirmed lower urinary tract dysfunction during urodynamic assessment (NDO, DSD)
• Intolerant, refractory or inefficient to conservative treatment options such as medications and behavioural management
• Using intermittent self-catheterization
• Stable medical, physical and psychological condition as considered by the investigators
• Able to understand and interact with the study team in French or English
• Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments

Who cannot take part

• Botulinum toxin vesical injections in the previous 6 months
• Previous lower urinary tract surgery
• Other clinically significant concomitant disease states (e.g., syringomyelia, bladder cancer, renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Participation in another study with investigational drug or device within the 30 days preceding and during the present study
• Recurrent and symptomatic urinary tract infection (more than 3 per year)
• Diseases and conditions that would increase the morbidity and mortality of spinal surgery
• Presence of pacemakers for cardiac conditions
• Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
• Inability to follow the procedures of the study, e.g. due to language problems, mental illness, psychological disorders, or dementia of the participant
• Presence of non-pharmacological treatments for lower urinary tract dysfunction (e.g. sacral nerve stimulation)
• Does have or needs a suprapubic catheter or bladder indwelling catheter
• Presence of upper urinary tract dilatation or bladder or renal stones
• Presence of urethral stricture or significant benign prostate hyperplasia
• Presence of significant pressure ulcers
• Presence of Autonomic Dysreflexia during urodynamic test
• Presence of intrathecal baclofen pump
• The inability to withhold antiplatelet/anticoagulation agents perioperatively
• Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding
• Lack of acceptable or highly effective method of contraception for women of childbearing capacity
• Intention to become pregnant during the course of the study
• Have any indication that would require Magnetic Resonance Imaging (MRI)
• Is the investigator himself, his/her family members, employees or other dependent persons