Electrical Control of Bladder in Spinal Cord Injury Patients

This study has been completed.

First Received: February 22, 2001 Last Updated: April 25, 2008 History of Changes

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00011570

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 II

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Electrical Control of Bladder in Spinal Cord Injury Patients

Further study details as provided by Department of Veterans Affairs:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Spinal cord injury with bowel & bladder problems

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011570

Locations

United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Donald Bodner, MD

VA Medical Center, Cleveland

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs ( Bodner, Donald - Principal Investigator )
Study ID Numbers:	B1770R
Study First Received:	February 22, 2001
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00011570 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

defecation
electrical stimulation
penile erection
Spinal cord injury
urology

Study placed in the following topic categories:

Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on May 06, 2009