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Recruiting
I'm InterestedTrial ID: NCT02978638
Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury
Inclusion Criteria:
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
Exclusion Criteria:
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
device: Finetech Vocare Bladder System
Recruiting
I'm Interested
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
SPECTRUM
6507042394