Electrical Stimulation for Spinal Cord Injury

Not currently recruiting at 3 trial locations

Overseen By Reza Ehsanian, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Palo Alto Veterans Institute for Research

Must not be taking: Anticoagulants

Disqualifiers: Pelvic fracture, Immunosuppression, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

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. ^{1 2 3 4 5}

Why 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. ^{1 3 6 7 8}

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

I have a complete spinal cord injury below the neck for over 2 years.

I have bladder control issues due to overactive bladder muscles.

My bladder doesn't empty properly due to a muscle issue, confirmed by a special bladder test.

Exclusion Criteria

I have active or recurring bedsores, especially on my lower back or hips.

People whose immune system is weakened.

I am on blood thinners or have a blood clotting disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgical Implantation

Surgical implantation of the Vocare Bladder System without posterior rhizotomy

1 week

1 visit (in-person)

Post-Implantation Evaluation

Evaluation of bladder capacity and continence using the implanted stimulator

4 weeks

2 visits (in-person)

Continued Use and Monitoring

Participants continue to use the stimulator and are reviewed at three-month intervals

12 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

1 visit (in-person)

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?

Group I: Finetech Vocare Bladder System Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Palo Alto Veterans Institute for Research

Lead Sponsor

Trials

58

Recruited

8,800+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Santa Clara Valley Medical Center

Collaborator

Trials

17

Recruited

2,400+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02978638

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).

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/H980005b.pdf

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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8117184/

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 ...

4. nature.com nature.com/articles/3101278

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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999301789514

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 ...

6. mrisafety.com mrisafety.com/SafetyInformation_view.php?editid1=242

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 ...

7. anthem.com anthem.com/medpolicies/abc/active/gl_pw_d090058.html

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 ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/H980008c.pdf

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 ...