Functional Magnetic Micturition in Patients w/SCI

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00011557
First received: February 22, 2001
Last updated: January 20, 2009
Last verified: January 2001

February 22, 2001
January 20, 2009
January 1998
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Complete list of historical versions of study NCT00011557 on ClinicalTrials.gov Archive Site
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Functional Magnetic Micturition in Patients w/SCI
Functional Magnetic Micturition in Patients w/SCI

This project will determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinal Cord Injury
Device: Assistance in Voiding
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2000
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Patients with SCI above T10 level, six months post injury

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00011557
B1747R
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Department of Veterans Affairs
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Investigator: John Fryer, Ph.D. Asst. Director Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Investigator: Nancy Rocheleau, Program Analyst Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Department of Veterans Affairs
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP