Urinary Incontinence Clinical Trial
Official title:
Treatment of Persistent Urinary Incontinence in Children
Verified date | May 2016 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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 improvement in two main markers of incontinence within/at 12 months after treatment.
Status | Completed |
Enrollment | 14 |
Est. completion date | October 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 18 Years |
Eligibility |
Inclusion Criteria: Urologic Inclusion Criteria: - 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 Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Children's and Women's Health Centre of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Vancouver Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life, as measured by a validated enuresis-specific quality of life scale | Unknown | No | |
Secondary | Any of the following radiographic findings leads to improved response to section of the filum: fat in the filum terminale, thickened filum terminale, presence of bifid lamina | Unknown | No | |
Secondary | Presence of a growth spurt in the 6 months following the section of the filum compared to the 6 months prior | Unknown | No | |
Secondary | Duration of urinary symptoms is negatively associated with improvement in urinary function | Unknown | No | |
Secondary | The following subtle neurological abnormalities are predictors of good outcome following filum section: strength or sensory dysfunction, clinical symptoms of back or leg pain, inability to touch toes with forward flexion | Unknown | No | |
Secondary | Section of the filum terminale leads to reduced frequency of urinary infections in the 12 months following surgery | Unknown | No |
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