← Back to Search

Electrical Stimulation

Electrical Stimulation for Spinal Cord Injury

N/A

Recruiting

Led By Graham H. Creasey, MD

Research Sponsored by Palo Alto Veterans Institute for Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 as shown on video-urodynamic testing

Must not have

External sphincterotomy, urethral stricture or previous urethral or sphincter or bladder or prostate surgery

History of pelvic fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline frequency of incontinence of urine at 12-month follow-up visit

Awards & highlights

No Placebo-Only Group

Summary

This trial will test an electrical stimulator to help improve bladder and bowel function in people with spinal cord injury.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, changes in bowel or sexual function, infection risk from surgery to implant the device, and possible interference with other medical devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

I have bladder control issues due to overactive bladder muscles.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have had a pelvic fracture in the past.

Select...

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

Select...

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

Select...

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

Select...

My spinal cord injury is getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline bladder capacity at 12-month follow-up visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline bladder capacity at 12-month follow-up visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline bladder capacity at 12-month follow-up visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bladder capacity

Secondary study objectives

Frequency of incontinence of urine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 9Eligibility criteria met