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Trial record 1 of 1 for:    NCT02978638
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Electrical Stimulation for Continence After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02978638
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
VA Palo Alto Health Care System
Stanford University
Case Western Reserve University
Information provided by (Responsible Party):
Graham Creasey, Palo Alto Veterans Institute for Research

Brief Summary:

This study aims to improve continence 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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Neurogenic Bladder Incontinence Device: Finetech Vocare Bladder System Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Finetech Vocare Bladder System
This is a pilot study of the Finetech Vocare Bladder System to improve continence 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.
Device: Finetech Vocare Bladder System
Participants will be implanted with the existing FDA-approved Finetech Vocare Bladder System stimulator and electrodes.




Primary Outcome Measures :
  1. Bladder capacity [ Time Frame: Change from baseline bladder capacity at 12-month follow-up visit ]
    Bladder capacity (ml.) measured during filling cystometry


Secondary Outcome Measures :
  1. Frequency of incontinence of urine [ Time Frame: Change from baseline frequency of incontinence of urine at 12-month follow-up visit ]
    Frequency of incontinence determined from diary data collected by the subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects will be included if they meet all of the following criteria:

  • 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 (unco-ordinated contraction of bladder and external urethral sphincter) as shown on video-urodynamic testing. The criteria for DESD diagnosis will be the presence of an open bladder neck without stress incontinence, with a closed external urethral sphincter during the filling or voiding phase of fluoroscopic assisted urodynamic studies.
  • Impaired continence due to detrusor hyper-reflexia

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

  • Absence of reflex contractions of the bladder as shown on urodynamic testing
  • Absence of reflex contractions of the external urethral sphincter as shown on urodynamic testing with EMG
  • External sphincterotomy, urethral stricture or previous urethral or sphincter or bladder or prostate surgery
  • History of pelvic fracture
  • Subjects on anticoagulants or with coagulation disorders
  • Immunosuppressed subjects
  • Active or recurrent pressure ulcers, particularly in sacral, ischial or trochanteric areas
  • Active untreated infection
  • Active implanted medical device such as cardiac pacemaker or defibrillator
  • Progressive spinal cord injury
  • Pregnancy
  • Mechanical ventilator dependency
  • Any other significant co-morbidity or illness that would preclude their participation or increase the risk to them of participating in the study
  • Inability or unwillingness to follow study protocol or give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978638


Contacts
Contact: Graham H. Creasey, MD 650-493-5000 ext 65040
Contact: Zoia Latev, PhD 650-493-5000 ext 63048

Locations
United States, California
Palo Alto Vetaran Institute for Research Recruiting
Palo Alto, California, United States, 94304
Contact: Graham Creasey, MD    650-493-5000 ext 65040      
Contact: Zoia Latev, PhD    650-493-5000 ext 63048      
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
VA Palo Alto Health Care System
Stanford University
Case Western Reserve University
Investigators
Principal Investigator: Graham H. Creasey, MD Palo Alto Vetarn Institute for Research

Publications:

Responsible Party: Graham Creasey, Professor, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT02978638     History of Changes
Other Study ID Numbers: CRE0004AGG
W81XWH-14-2-0132 ( Other Grant/Funding Number: Department of Defense )
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Graham Creasey, Palo Alto Veterans Institute for Research:
Spinal cord injury
Bladder capacity
Electrical stimulation
Continence
Urodynamics

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms