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Electrical Control of Bladder in Spinal Cord Injury Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00011570
First Posted: February 26, 2001
Last Update Posted: April 28, 2008
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
February 22, 2001
February 26, 2001
April 28, 2008
April 1998
October 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00011570 on ClinicalTrials.gov Archive Site
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Electrical Control of Bladder in Spinal Cord Injury Patients
Electrical Control of Bladder in Spinal Cord Injury Patients
The investigators will continue their work with implanted stimulators to improve bladder and bowel function. Electrical stimulation produces simultaneous contraction of sphincters with the target organs, making emptying difficult. By optimizing electrode placement, employing a new electrode design and waveform choice, it is hoped to improve the 50% of subjects able to defecate with existing approaches. This is part of a multi-center study with multiple support sources, including Rehab R&D, PVA and a commercial stimulator company.
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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Spinal Cord Injury
Device: Bladder & Bowel Control
1
Intervention: Device: Bladder & Bowel Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
November 2007
October 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Spinal cord injury with bowel & bladder problems

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00011570
B1770R
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Bodner, Donald - Principal Investigator, Department of Veterans Affairs
VA Office of Research and Development
Not Provided
Principal Investigator: Donald Bodner, MD VA Medical Center, Cleveland
VA Office of Research and Development
April 2008

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