Electrical Stimulation for Continence After Spinal Cord Injury

Launched by PALO ALTO VETERANS INSTITUTE FOR RESEARCH · Nov 30, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a device called the Finetech Vocare Bladder System, which uses electrical stimulation to help improve bladder control for people who have had a spinal cord injury. The goal is to help patients achieve better continence (the ability to control urination) and to make it easier for them to empty their bladders. Unlike some previous treatments that involved cutting nerves, this study focuses on using the device to stimulate the nerves without surgery, potentially leading to better outcomes and fewer side effects.

To be eligible for this study, participants must have a complete spinal cord injury (meaning they have no feeling or movement below the injury) for at least two years and experience problems with bladder emptying and control. Those interested should be aware that they will need to follow specific guidelines, and they will undergo assessments to ensure they qualify. Participants can expect to receive care and support throughout the trial, and their experiences may help improve treatments for others with similar conditions in the future.

Gender

ALL

Eligibility criteria

• 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