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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
  Purpose
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.

Condition Intervention Phase
Spinal Cord Injury Device: Bladder & Bowel Control Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electrical Control of Bladder in Spinal Cord Injury Patients

Resource links provided by NLM:


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

Estimated Enrollment: 18
Study Start Date: April 1998
Study Completion Date: November 2007
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Device: Bladder & Bowel Control

  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

Inclusion Criteria:

Spinal cord injury with bowel & bladder problems

Exclusion Criteria:

  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): NCT00011570


Locations
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Donald Bodner, MD VA Medical Center, Cleveland
  More Information

Responsible Party: Bodner, Donald - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00011570     History of Changes
Other Study ID Numbers: B1770R
First Submitted: February 22, 2001
First Posted: February 26, 2001
Last Update Posted: April 28, 2008
Last Verified: April 2008

Keywords provided by VA Office of Research and Development:
defecation
electrical stimulation
penile erection
Spinal cord injury
urology

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