Status:
COMPLETED
Treatment of Persistent Urinary Incontinence in Children
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Vancouver Foundation
Conditions:
Urinary Incontinence
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether surgical section of the filum terminale in children, when added to standard medical therapy, will result in a reliable and clinically-significant impr...
Detailed Description
Eight % to sixteen % of school-aged children or approximately 50,000 children in British Columbia (BC) suffer from persistent urinary incontinence (i.e., beyond age 5 years, when continence is usually...
Eligibility Criteria
Inclusion
- Urologic
- Primary or secondary daytime urinary incontinence, persistent over 12 months of medical treatment
- An abnormal 3 day voiding diary compiled over a 3 week voiding period completed after 12 months of medical treatment
- Normal bladder ultrasound (if bladder ultrasound shows more than minimal bladder thickening \[\>3.0mm at 50% filling of expected capacity or less\] then a voiding cystourethrogram \[VCUG\] will be required to rule out bladder outlet obstruction)
- Abnormal urodynamic testing
- Radiologic
- Normal position conus medullaris
- Any size filum terminale
- Any amount of fat in the filum terminale
- Terminal syringomyelia of less than one bony level is acceptable
- Lumbar bifid spinal lamina is acceptable
Exclusion
- Patients with evidence of significant, progressive, lower extremity motor or sensory deficits, with evidence of progression over the previous 6 months
- The presence of cutaneous markings on the back, in the absence of confirmatory magnetic resonance imaging (MRI) findings of a specific spinal dysraphism does not exclude the patient from participation
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00124046
Start Date
September 1 2005
End Date
October 1 2015
Last Update
June 1 2016
Active Locations (1)
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1
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4