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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bladder capacity

Secondary outcome measures

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Palo Alto Health Care SystemFED

87 Previous Clinical Trials

56,853 Total Patients Enrolled

University of New MexicoOTHER

372 Previous Clinical Trials

3,528,779 Total Patients Enrolled

Palo Alto Veterans Institute for ResearchLead Sponsor

52 Previous Clinical Trials

7,895 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographical scope of this medical experiment?

"There are 4 active sites for this trial, namely MetroHealth Medical Center in Cleveland, Palo Alto Veterans Institute for Research in Palo Alto and University of New mexico in Albuquerque. Additionally, there are other recruitment centers available."

Answered by AI

Is this research initiative actively recruiting participants?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial is presently recruiting volunteers, with the original posting date being September 1st 2014 and a subsequent update on April 18th 2022. 10 subjects are needed from 4 different healthcare facilities."

Answered by AI

What is the upper limit on participant recruitment for this trial?

"Affirmative. Based on the information hosted on clinicaltrials.gov, this study is actively seeking participants - it was initially posted in September of 2014 and has recently been updated in April 2022. A total of 10 volunteers from 4 distinct sites are desired for recruitment into the trial."

Answered by AI