Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale

Study Overview
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Brief Summary
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The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy. The study hypothesis is that patients who under go cutting the filum terminale - the string-like lower end of the spinal cord - will have improved bladder function at 6-month follow up. Bladder function and its effects on quality of life will be measured before surgery and at 6-month follow up.

Official Title
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A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus

Conditions
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Neurogenic Incontinence, Dysfunctional Voiding

Intervention / Treatment
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* Procedure: Division of the filum terminal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary or secondary daytime urinary incontinence, persistent over at least 6 months of medical treatment. Abnormal urodynamic testing Normal conus on magnetic resonance imaging of the spine Dysfunctional Voiding Symptom Scale score greater than 6 for girls or greater than 9 for boys Exclusion Criteria: Bladder outlet obstruction Bladder atony Congenital anorectal malformation Additional diagnoses independently associated with neurogenic bladder dysfunction Encephalopathy precluding reasonable expectation of attainment of continence Inability to comply with medical management Unwillingness to comply with initial or follow up urodynamic testing

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neurogenic incontinence<br>The target population of this study is children with primary or secondary daytime urinary incontinence, who have failed to improve adequately despite compliance with at least 6 months of standard medical therapy. These children will have abnormal urodynamics, a normal bladder ultrasound and an MR imaging showing that the conus of the spinal cord is at a normal position and that there is no other significant dysraphic lesion present. | Procedure: Division of the filum terminal<br>* Division of the filum is performed through a 6cm incision over the lumbosacral junction that can be oriented either longitudinally or transversely - to be hidden beneath underclothes or swim wear. A single level laminectomy provides sufficient exposure. The dural opening can be as short as 1cm. Under the microscope the filum is identified visually and separated from lower sacral rootlets with the aid of microelectrode stimulation. When a segment of the filum has been excised and sent for laboratory examination, the dura is closed and reinforced with fibrin glue. The wound is closed in layers, and the patient is kept at bed rest horizontal for 2 nights to discourage CSF fistulization of the wound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life |  | 6-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in a 24-hour voiding log |  | 6-month follow up | 
| Change from baseline in the Dysfunctional Voiding Symptom Scale |  | 6-month follow up | 
| Change from baseline urodynamic testing |  | 6-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incontinence, conus, dysfunctional voiding, neurogenic bladder disturbance, filum terminale, spinal cord tethering