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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

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
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I have a complete spinal cord injury below the neck for over 2 years.
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My bladder doesn't empty properly due to a muscle issue, confirmed by a special bladder test.
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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:
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I have had surgery on my bladder, prostate, urethra, or sphincter.
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I have had a pelvic fracture in the past.
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I am on blood thinners or have a blood clotting disorder.
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I have active or recurring bedsores, especially on my lower back or hips.
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I have an infection that hasn't been treated yet.
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My spinal cord injury is getting worse.

Timeline

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

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.

Find a Location

Who is running the clinical trial?

VA Palo Alto Health Care SystemFED
92 Previous Clinical Trials
58,149 Total Patients Enrolled
University of New MexicoOTHER
383 Previous Clinical Trials
3,523,184 Total Patients Enrolled
Palo Alto Veterans Institute for ResearchLead Sponsor
55 Previous Clinical Trials
8,342 Total Patients Enrolled
~0 spots leftby Sep 2024
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