Status:
COMPLETED
Two Devices for Reflex Voiding Following Spinal Cord Injury
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Spinal Cord Injury
Urinary Incontinence
Eligibility:
MALE
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this investigation is to evaluate methods in spinal cord injured individuals to improve reflex urination. Anal dilation will be investigated to reduce high urethral resistance and a vib...
Detailed Description
Catheters are often used by individuals emptying their bladder following spinal cord injury. Reflex voiding is one of the bladder emptying methods, and it relies on spontaneous bladder contractions fo...
Eligibility Criteria
Inclusion
- Male Veterans using Hines VA Hospital SCI Service that have upper motor neuron injuries
Exclusion
- Can voluntarily control their urination
- Surgically removed external urethral sphincter in men or replaced bladder
- Any implanted devices in the lower urinary tract
- Female
- Urinary tract infection in the prior 3 months or untreated urinary tract infection, or bladder pathology such as a tumor or stones
- History of autonomic dysreflexia
- Anal inflammation or pathology
- Use of Indwelling (Foley) catheter as the primary method of bladder management; note patients will be included if they only occasionally use a Foley catheters; for example, during traveling
- Not under 18 or over 70 years old and in good health
- Less than 3-months after injury and before the return of bladder reflexes
- Lower motor neuron spinal cord injury
- Not competent to understand the study and the consent and willing to participate in study.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00662207
Start Date
October 1 2008
End Date
October 1 2009
Last Update
November 5 2014
Active Locations (1)
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1
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000