Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale (NICNOC)
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.
|Neurogenic Incontinence Dysfunctional Voiding||Procedure: Division of the filum terminal|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus|
- Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life [ Time Frame: 6-month follow up ]
- Change from baseline in a 24-hour voiding log [ Time Frame: 6-month follow up ]
- Change from baseline in the Dysfunctional Voiding Symptom Scale [ Time Frame: 6-month follow up ]
- Change from baseline urodynamic testing [ Time Frame: 6-month follow up ]
|Study Start Date:||July 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465581
|United States, Delaware|
|A I duPont Hospital for Children|
|Wilmington, Delaware, United States, 19803|
|Principal Investigator:||Joseph H Piatt, MD||Alfred I. duPont Hospital for Children|