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Electrical Control of Bladder in Spinal Cord Injury Patients

NCT ID: NCT00011570

Last Updated: 2008-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury

Keywords

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defecation electrical stimulation penile erection Spinal cord injury urology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Bladder & Bowel Control

Intervention Type DEVICE

Interventions

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Bladder & Bowel Control

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Spinal cord injury with bowel \& bladder problems
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Department of Veterans Affairs

Principal Investigators

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Donald Bodner, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center-Cleveland

Locations

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VA Medical Center, Cleveland

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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B1770R

Identifier Type: -

Identifier Source: org_study_id