Electrical Control of Bladder in Spinal Cord Injury Patients

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 2

Conditions: Spinal Cord Injury

Treatments: Device: Bladder & Bowel Control

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00011570

B1770R

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Spinal cord injury with bowel & bladder problems

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

1

Other group

Treatment:

Device: Bladder & Bowel Control