Improving bladder control after spinal cord injury using electrical stimulation
Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury
NA · Palo Alto Veterans Institute for Research · NCT02978638
This study is testing a new device that uses gentle electrical stimulation to help people with spinal cord injuries improve their bladder control.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Palo Alto Veterans Institute for Research (other) |
| Locations | 4 sites (Palo Alto, California and 3 other locations) |
| Trial ID | NCT02978638 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance bladder function in patients with spinal cord injury through the use of the Finetech Vocare Bladder System, an implantable sacral nerve stimulator. Unlike traditional methods that involve cutting sensory nerves, this approach utilizes low levels of electrical stimulation to improve bladder contraction and voiding without the associated side effects. Participants will undergo screening to determine their eligibility based on their reflex bladder contractions, followed by surgical implantation of the device if they qualify. The effectiveness of the stimulation will be evaluated through clinical urodynamic assessments.
Who should consider this trial
Good fit: Ideal candidates are individuals with complete spinal cord injury (AIS grade A) for at least two years, experiencing impaired bladder emptying and continence.
Not a fit: Patients who do not exhibit reflex bladder contractions or have undergone certain prior surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bladder control and quality of life for patients with spinal cord injuries.
How similar studies have performed: Previous studies using similar electrical stimulation techniques have shown promise, but this specific approach without nerve cutting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California and 3 other locations
- Palo Alto Veterans Institute for Research — Palo Alto, California, United States (RECRUITING)
- Santa Clara Valley Medical Center — San Jose, California, United States (RECRUITING)
- University of New Mexico — Albuquerque, New Mexico, United States (RECRUITING)
- MetroHealth Medical Center — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Graham H. Creasey, MD — Palo Alto Veterans Institute for Research
- Study coordinator: Graham H. Creasey, MD
- Email: gcreasey@stanford.edu
- Phone: 650-704-2394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injury, Neurogenic Bladder, Incontinence, Spinal cord injury, Bladder capacity, Electrical stimulation, Continence, Urodynamics