Functional Magnetic Micturition in Patients w/SCI
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|ClinicalTrials.gov Identifier: NCT00011557|
Recruitment Status : Completed
First Posted : February 26, 2001
Last Update Posted : January 21, 2009
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: Assistance in Voiding||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Functional Magnetic Micturition in Patients w/SCI|
|Study Start Date :||January 1998|
|Study Completion Date :||December 2000|
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
|United States, California|
|VAMC, Long Beach|
|Long Beach, California, United States|
|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|