Electrical Control of Bladder in Spinal Cord Injury Patients

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00011570
First received: February 22, 2001
Last updated: April 25, 2008
Last verified: April 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Donald Bodner, MD VA Medical Center, Cleveland
  More Information

No publications provided

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

Keywords provided by Department of Veterans Affairs:
defecation
electrical stimulation
penile erection
Spinal cord injury
urology

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

ClinicalTrials.gov processed this record on September 18, 2014