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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00011557
Other study ID # B1747R
Secondary ID
Status Completed
Phase Phase 2
First received February 22, 2001
Last updated January 20, 2009
Start date January 1998
Est. completion date December 2000

Study information

Verified date January 2001
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Patients with SCI above T10 level, six months post injury

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Assistance in Voiding


Locations

Country Name City State
United States VAMC, Long Beach Long Beach California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

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