Electrical Stimulation for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment for individuals with spinal cord injuries to improve bladder control and function. It employs the Finetech Vocare Bladder System, an implant that sends electrical signals to specific nerves to enhance bladder and bowel functions. Unlike older methods, this approach avoids cutting sensory nerves, aiming to improve continence and ease of voiding. It suits those who have had a complete spinal cord injury for over two years, experience bladder coordination issues, and struggle with holding urine due to overactive bladder reflexes. As an unphased trial, this study offers patients a unique opportunity to contribute to groundbreaking research in spinal cord injury treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners) or have an active implanted medical device, you may not be eligible to participate.
What prior data suggests that the Finetech Vocare Bladder System is safe for improving continence and voiding in spinal cord injury patients?
Research has shown that the Finetech Vocare Bladder System is generally safe for people with spinal cord injuries. Since its introduction in 1982, this system has helped thousands of patients worldwide. It received FDA approval in 1998, meeting strict safety standards for improving bladder and bowel function.
Studies have found that the system uses low levels of electrical stimulation, which are safe for patients. No reports have indicated cutting sensory nerves, which can cause unwanted side effects. This method focuses on stimulating nerves to aid bladder control and emptying without invasive nerve cutting. Overall, the treatment is well-tolerated and has a proven record of helping people with spinal cord injuries manage bladder and bowel function.12345Why are researchers excited about this trial?
Unlike the standard treatments for spinal cord injury-related bladder issues, which often include medications or catheterization, the Finetech Vocare Bladder System uses electrical stimulation to improve bladder function. This system is unique because it directly stimulates the nerves controlling the bladder, potentially restoring natural continence and voiding. Researchers are excited about this approach because it offers a non-invasive way to enhance quality of life for individuals with chronic spinal cord injuries, by reducing reliance on catheters and minimizing complications associated with long-term catheter use.
What is the effectiveness track record for the Finetech Vocare Bladder System in improving continence and voiding for spinal cord injury patients?
Research has shown that the Finetech Vocare Bladder System can improve bladder and bowel function in people with spinal cord injuries. This system uses electrical signals to control bladder emptying and bowel movements. Studies have found that it can increase bladder capacity by stimulating certain nerves, potentially reducing the need for surgeries. Since the 1980s, many patients have successfully used it, and it is approved for specific uses in the U.S. In this trial, participants will test the system without cutting sensory nerves, aiming for better results with fewer side effects.13678
Who Is on the Research Team?
Reza Ehsanian, MD PhD
Principal Investigator
University of New Mexico
Graham H. Creasey, MD
Principal Investigator
Palo Alto Veterans Institute for Research
Are You a Good Fit for This Trial?
This trial is for adults with complete spinal cord injury below C4, lasting at least 2 years, who have trouble emptying their bladder or keeping urine in due to nerve issues. It's not for those without reflex bladder contractions, previous major pelvic surgeries, bleeding disorders, immune system problems, other serious illnesses or conditions like active infections or pressure ulcers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Implantation
Surgical implantation of the Vocare Bladder System without posterior rhizotomy
Post-Implantation Evaluation
Evaluation of bladder capacity and continence using the implanted stimulator
Continued Use and Monitoring
Participants continue to use the stimulator and are reviewed at three-month intervals
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Finetech Vocare Bladder System
Trial Overview
The study tests the Finetech Vocare Bladder System—an implantable device that stimulates sacral nerves to improve bladder and bowel control in spinal cord injury patients—without cutting sensory nerves. The goal is better continence and voiding without the side effects of nerve cutting.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This is a pilot study of the Finetech Vocare Bladder System to improve continence and voiding in human subjects with chronic spinal cord injury. Each subject will act as their own control, comparing function with the Finetech Vocare Bladder System in use and not in use.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Palo Alto Veterans Institute for Research
Lead Sponsor
VA Palo Alto Health Care System
Collaborator
University of New Mexico
Collaborator
Santa Clara Valley Medical Center
Collaborator
Stanford University
Collaborator
Case Western Reserve University
Collaborator
Citations
Electrical Stimulation for Continence After Spinal Cord Injury
The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving bladder and bowel function in patients with spinal cord injury (SCI).
SUMMARY OF SAFETY AND PROBABLE BENEFIT
It was concluded that the VOCARE Bladder System delivers safe electrical stimulation parameters to the Extradural Electrodes. 1.7 Animal Studies.
Translating promising strategies for bowel and bladder ...
Improvements in bladder, bowel and sexual outcomes following task-specific locomotor training in human spinal cord injury. PLoS One 13 (1), e0190998 ...
Neuromodulation through sacral nerve roots 2 to 4 with a ...
To use the established Finetech-Brindley sacral root stimulator to increase bladder capacity by neuromodulation, eliminating the need for posterior rhizotomy.
Economic consequences of an implanted neuroprosthesis ...
GH Creasey et al. An implantable neuroprosthesis for restoring bladder and bowel control to patients with spinal cord injuries: a multicenter trial. Arch ...
Safety Topic/Article:
The VOCARE Bladder System/Finetech-Brindley Bladder System (Vocare) delivers low levels of electrical stimulation to a spinal cord injured patient's intact ...
CG-SURG-95 Sacral Nerve Stimulation for Urinary ...
The Neurocontrol Vocare Bladder System is indicated for the treatment of patients who have clinically complete spinal cord lesions with intact parasympathetic ...
NeuroControl Corporation VOCARE Bladder System ...
The NeuroControl VOCARE Bladder System is indicated for the treatment of patients who have clinically complete spinal cord lesions (ASIA ...
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