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Electrical Control of Bladder in Spinal Cord Injury Patients

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bladder & Bowel Control
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring defecation, electrical stimulation, penile erection, Spinal cord injury, urology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Spinal cord injury with bowel & bladder problems Exclusion Criteria:

Sites / Locations

  • VA Medical Center, Cleveland

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 22, 2001
Last Updated
April 25, 2008
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00011570
Brief Title
Electrical Control of Bladder in Spinal Cord Injury Patients
Official Title
Electrical Control of Bladder in Spinal Cord Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
defecation, electrical stimulation, penile erection, Spinal cord injury, urology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Bladder & Bowel Control

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spinal cord injury with bowel & bladder problems Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Bodner, MD
Organizational Affiliation
VA Medical Center, Cleveland
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Electrical Control of Bladder in Spinal Cord Injury Patients

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