Electrical Stimulation for Continence After Spinal Cord Injury
Trial ID or NCT#
This study aims to improve continence and voiding of patients with spinal cord injury using electrical stimulation. The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving bladder and bowel function in patients with spinal cord injury (SCI). It has been commercially available in Britain and other countries since 1982, and has been used in thousands of patients with SCI to improve bladder, bowel and sexual function. It received FDA approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing urination on demand and to aid in bowel evacuation. Electrical stimulation to produce bladder contraction and improve bladder voiding after spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex contraction of the bladder, which improves continence. However, cutting these nerves has undesirable side effects. This study will not cut any sensory nerve. This study is testing the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to improve continence after spinal cord injury, and for blocking sphincter contraction to improve voiding.
Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury
- Subjects will be included if they meet all of the following criteria: - Complete spinal cord injury (AIS grade A) of at least 2 years duration with neurological level (ISNCSCI level) below C4 - Impaired bladder emptying due to Detrusor External Sphincter Dyssynergia-DESD (unco-ordinated contraction of bladder and external urethral sphincter) as shown on video-urodynamic testing. - Impaired continence due to detrusor hyper-reflexia
- Subjects will be excluded if they meet any of the following criteria: - Absence of reflex contractions of the bladder as shown on urodynamic testing - Absence of reflex contractions of the external urethral sphincter as shown on urodynamic testing with EMG - External sphincterotomy, urethral stricture or previous urethral or sphincter or bladder or prostate surgery - History of pelvic fracture - Subjects on anticoagulants or with coagulation disorders - Immunosuppressed subjects - Active or recurrent pressure ulcers, particularly in sacral, ischial or trochanteric areas - Active untreated infection - Active implanted medical device such as cardiac pacemaker or defibrillator - Progressive spinal cord injury - Pregnancy - Mechanical ventilator dependency - Any other significant co-morbidity or illness that would preclude their participation or increase the risk to them of participating in the study - Inability or unwillingness to follow study protocol or give informed consent
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