Functional Magnetic Micturition in Patients w/SCI

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00011557
First received: February 22, 2001
Last updated: January 20, 2009
Last verified: January 2001
  Purpose

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


Condition Intervention Phase
Spinal Cord Injury
Device: Assistance in Voiding
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: Functional Magnetic Micturition in Patients w/SCI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 36
Study Start Date: January 1998
Study Completion Date: December 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients with SCI above T10 level, six months post injury

  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: NCT00011557

Locations
United States, California
VAMC, Long Beach
Long Beach, California, United States
Sponsors and Collaborators
Investigators
Investigator: John Fryer, Ph.D. Asst. Director Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Investigator: Nancy Rocheleau, Program Analyst Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00011557     History of Changes
Other Study ID Numbers: B1747R
Study First Received: February 22, 2001
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Bladder, electromagnetic fields, Spinal cord injury

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

ClinicalTrials.gov processed this record on July 24, 2014