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Insufficient patient accrual.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurogenic incontinence | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Division of the filum terminal | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life | 6-month follow up |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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. These children will have abnormal urodynamics, a normal bladder ultrasound and an MR imaging showing that the conus medullaris of the spinal cord is at a normal position and that there is no other significant dysraphic lesion present. The entry criteria are designed to separate this very specific subset of patients from the much larger, more general group of children presenting for evaluation and management of incontinence.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph H Piatt, MD | Alfred I. duPont Hospital for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
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| 6-month follow up |