Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale (NICNOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01465581|
Recruitment Status : Terminated (Insufficient patient accrual.)
First Posted : November 7, 2011
Last Update Posted : April 17, 2015
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.
|Condition or disease||Intervention/treatment|
|Neurogenic Incontinence Dysfunctional Voiding||Procedure: Division of the filum terminal|
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|