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Functional Magnetic Micturition in Patients w/SCI

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00011557
First Posted: February 26, 2001
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  Purpose
This project will determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.

Condition Intervention Phase
Spinal Cord Injury Device: Assistance in Voiding Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Magnetic Micturition in Patients w/SCI

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Estimated Enrollment: 36
Study Start Date: January 1998
Study Completion Date: December 2000
Detailed Description:

Investigators intend to determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.

Thirty six persons will be recruited and will undergo an 8 week protocol for conditioning of the bladder. The investigators propose to: investigate the changes in bladder function in response to long-term bladder conditioning by FMS; further optimize the FMS technology and parameters for effective bladder emptying in SCI; evaluate the role of the external sphincter muscle fatigue by FS in facilitating bladder emptying; critically evaluate the relative response of FMS data to existing information using functional electrical stimulation;further develop criteria that will be used to predict which SCI patients are optimally suitable for FMS; establish a comprehensive stimulation criteria that will reflect the safety and effectiveness of structures associated with the bladder that are exposed to the electro-myographic field.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Patients with SCI above T10 level, six months post injury
  Contacts and Locations
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): NCT00011557


Locations
United States, California
VAMC, Long Beach
Long Beach, California, United States
Sponsors and Collaborators
VA Office of Research and Development
Investigators
OverallOfficial: John Fryer, Ph.D. Asst. Director Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
OverallOfficial: Nancy Rocheleau, Program Analyst Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
  More Information

ClinicalTrials.gov Identifier: NCT00011557     History of Changes
Other Study ID Numbers: B1747R
First Submitted: February 22, 2001
First Posted: February 26, 2001
Last Update Posted: January 21, 2009
Last Verified: January 2001

Keywords provided by VA Office of Research and Development:
Bladder, electromagnetic fields, Spinal cord injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries