Electrical Stimulation for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen ByGraham H. Creasey, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Palo Alto Veterans Institute for Research

No Placebo Group

Trial Summary

What is the purpose of this trial?This study aims to improve continence and voiding of patients with spinal cord injury using electrical stimulation. The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving bladder and bowel function in patients with spinal cord injury (SCI). It has been commercially available in Britain and other countries since 1982, and has been used in thousands of patients with SCI to improve bladder, bowel and sexual function. It received FDA approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing urination on demand and to aid in bowel evacuation. Electrical stimulation to produce bladder contraction and improve bladder voiding after spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex contraction of the bladder, which improves continence. However, cutting these nerves has undesirable side effects. This study will not cut any sensory nerve. This study is testing the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to improve continence after spinal cord injury, and for blocking sphincter contraction to improve voiding.

Eligibility Criteria

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.

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

I have bladder control issues due to overactive bladder muscles.

Exclusion Criteria

I have had surgery on my bladder, prostate, urethra, or sphincter.

I have had a pelvic fracture in the past.

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

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

I have an infection that hasn't been treated yet.

My spinal cord injury is getting worse.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Finetech Vocare Bladder SystemExperimental Treatment1 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.