Functional Magnetic Micturition in Patients w/SCI

NCT ID: NCT00011557

Last Updated: 2009-01-21

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2000-12-31

Brief Summary

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This project will determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.

Detailed Description

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Investigators intend to determine the ultimate usefulness of functional magnetic stimulation (FMS) as an assistive device for voiding in patients with SCI.

Thirty six persons will be recruited and will undergo an 8 week protocol for conditioning of the bladder. The investigators propose to: investigate the changes in bladder function in response to long-term bladder conditioning by FMS; further optimize the FMS technology and parameters for effective bladder emptying in SCI; evaluate the role of the external sphincter muscle fatigue by FS in facilitating bladder emptying; critically evaluate the relative response of FMS data to existing information using functional electrical stimulation;further develop criteria that will be used to predict which SCI patients are optimally suitable for FMS; establish a comprehensive stimulation criteria that will reflect the safety and effectiveness of structures associated with the bladder that are exposed to the electro-myographic field.

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Assistance in Voiding

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients with SCI above T10 level, six months post injury
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

Principal Investigators

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John Fryer, Ph.D. Asst. Director

Role:

Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

Nancy Rocheleau, Program Analyst

Role:

Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

Locations

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VAMC, Long Beach

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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B1747R

Identifier Type: -

Identifier Source: org_study_id

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