Treatment of Persistent Urinary Incontinence in Children (NCT00124046) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Persistent Urinary Incontinence in Children
Canada14 participantsStarted 2005-09
Plain-language 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 improvement in two main markers of incontinence within/at 12 months after treatment.
Who can participate
Age range5 Years – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Quality of life, as measured by a validated enuresis-specific quality of life scale