ACTIVE_NOT_RECRUITING

Electrical Stimulation for Continence After Spinal Cord Injury

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Conditions

Spinal Cord InjuryNeurogenic BladderIncontinenceBladder capacityElectrical stimulationContinenceUrodynamics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury

Quick Facts

Study Start:2014-09
Study Completion:2025-09-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02978638

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Complete spinal cord injury (AIS grade A) of at least 2 years duration with neurological level (ISNCSCI level) below C4
  2. * 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.
  3. * Impaired continence due to detrusor hyper-reflexia
  1. * Absence of reflex contractions of the bladder as shown on urodynamic testing
  2. * Absence of reflex contractions of the external urethral sphincter as shown on urodynamic testing with EMG
  3. * External sphincterotomy, urethral stricture or previous urethral or sphincter or bladder or prostate surgery
  4. * History of pelvic fracture
  5. * Subjects on anticoagulants or with coagulation disorders
  6. * Immunosuppressed subjects
  7. * Active or recurrent pressure ulcers, particularly in sacral, ischial or trochanteric areas
  8. * Active untreated infection
  9. * Active implanted medical device such as cardiac pacemaker or defibrillator
  10. * Progressive spinal cord injury
  11. * Pregnancy
  12. * Mechanical ventilator dependency
  13. * Any other significant co-morbidity or illness that would preclude their participation or increase the risk to them of participating in the study
  14. * Inability or unwillingness to follow study protocol or give informed consent

Contacts and Locations

Principal Investigator

Graham H. Creasey, MD
PRINCIPAL_INVESTIGATOR
Palo Alto Veterans Institute for Research
Reza Ehsanian, MD PhD
STUDY_DIRECTOR
University of New Mexico

Study Locations (Sites)

Palo Alto Veterans Institute for Research
Palo Alto, California, 94304
United States
Santa Clara Valley Medical Center
San Jose, California, 95128
United States
University of New Mexico
Albuquerque, New Mexico, 87106
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States

Collaborators and Investigators

Sponsor: Palo Alto Veterans Institute for Research

  • Graham H. Creasey, MD, PRINCIPAL_INVESTIGATOR, Palo Alto Veterans Institute for Research
  • Reza Ehsanian, MD PhD, STUDY_DIRECTOR, University of New Mexico

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-09
Study Completion Date2025-09-28

Study Record Updates

Study Start Date2014-09
Study Completion Date2025-09-28

Terms related to this study

Keywords Provided by Researchers

  • Spinal cord injury
  • Bladder capacity
  • Electrical stimulation
  • Continence
  • Urodynamics

Additional Relevant MeSH Terms

  • Spinal Cord Injury
  • Neurogenic Bladder
  • Incontinence