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 range
5 Years – 18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of life, as measured by a validated enuresis-specific quality of life scale