Dysfunctional Voiding, Neurogenic Incontinence
Conditions
Keywords
incontinence, dysfunctional voiding, neurogenic bladder disturbance, filum terminale, spinal cord tethering, conus
Brief summary
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.
Interventions
PROCEDUREDivision of the filum terminal
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.
Sponsors
Nemours Children's Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life | 6-month follow up |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline urodynamic testing | 6-month follow up |
| 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 |
Countries
United States
Outcome results
None listed