Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011557
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-02-22
Brief Title:
Functional Magnetic Micturition in Patients wSCI
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Functional Magnetic Micturition in Patients wSCI
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project will determine the ultimate usefulness of functional magnetic stimulation FMS as an assistive device for voiding in patients with SCI
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 stimulationfurther 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
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 stimulationfurther 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None