Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124046
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2005-07-22
Brief Title:
Treatment of Persistent Urinary Incontinence in Children
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Treatment of Persistent Urinary Incontinence in Children
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether surgical section of the filum terminale in children when added to standard medical therapy will result in a reliable and clinically-significant improvement in two main markers of incontinence withinat 12 months after treatment
Detailed Description:
Eight to sixteen of school-aged children or approximately 50000 children in British Columbia BC suffer from persistent urinary incontinence ie beyond age 5 years when continence is usually achieved Prevalence decreases with age yet studies indicate that 10-25 of healthy adolescents and young adults also suffer from incontinence Persistent incontinence has profound social emotional and behavioral impacts and adversely affects the quality of life of affected children and their families
Typical management of incontinence in these patients includes repeated visits to the family doctor and long-term lifestyle changes andor prescription use Each year in BC family doctors refer about 4500 children to pediatric urologists at BC Childrens Hospital BCCH BCCH is the only tertiary care facility for children and youth in the province so that children and parents come from all over BC for these appointments and for diagnostic urodynamics testing Of these children who are evaluated by pediatric urologists each year approximately 900 20 are designated as having dysfunctional voiding In this group following one year of non-responsiveness to medical treatment medication lifestyle the urologist may refer the child to neurosurgery for assessment and possible surgery
In recent years the referral rate of children with incontinence to BCCH Neurosurgery has increased markedly from 1-2 to 12-15 children per year This referral is because urinary incontinence in children is one of the clinical features of a tethered cord syndrome In this syndrome the lower end of the spinal cord the conus is pulled down lower than normal by a thickened band of tissue called the filum terminale which runs inferiorly from the bottom of the spinal cord This tethered condition can be treated by surgical section of the filum terminale More recently the concept of an occult tethered cord syndrome OTCS has been proposed in OTCS clinical symptoms eg incontinence are consistent with a tethered cord syndrome but the conus ends at a normal location The concept of the OTCS is controversial and it is not yet clear whether or not section of the filum is appropriate Filum section is a relatively minor procedure akin to appendectomy that requires general anesthesia during day surgery In uncontrolled case series section of the filum terminale in children with OTCS resulted in a 60-97 improvement in symptoms
Given this evidence that section of the filum may improve incontinence symptoms urologists are keen to refer more patients to neurosurgeons Furthermore families are demanding more tests and options and are ready to pursue surgery as treatment of their childs incontinence This suggests that the referral rate to Neurosurgery will continue to increase and there will be a crucial requirement to develop standard policies and procedures related to offering this surgery to children with incontinence As yet however the effectiveness and appropriateness of the surgery have not been evaluated systematically
To investigate this matter a comparison will be made between two randomized groups One group will undergo early tethered cord release by section of the filum terminale through a limited posterior lumbar spinal exposure and continued medical therapy for 12 months This group will be compared to a second that has continued standard medical therapy without surgical intervention for a further 12 months This comparison will be made based on physiological markers of urinary incontinence as measured by a urodynamic scale and quality of life as measured by a validated enuresis-specific quality of life scale The intervention will be considered to be successful if it improves the urodynamic score by 20 and the quality of life of the child and his family are significantly improved
Typical management of incontinence in these patients includes repeated visits to the family doctor and long-term lifestyle changes andor prescription use Each year in BC family doctors refer about 4500 children to pediatric urologists at BC Childrens Hospital BCCH BCCH is the only tertiary care facility for children and youth in the province so that children and parents come from all over BC for these appointments and for diagnostic urodynamics testing Of these children who are evaluated by pediatric urologists each year approximately 900 20 are designated as having dysfunctional voiding In this group following one year of non-responsiveness to medical treatment medication lifestyle the urologist may refer the child to neurosurgery for assessment and possible surgery
In recent years the referral rate of children with incontinence to BCCH Neurosurgery has increased markedly from 1-2 to 12-15 children per year This referral is because urinary incontinence in children is one of the clinical features of a tethered cord syndrome In this syndrome the lower end of the spinal cord the conus is pulled down lower than normal by a thickened band of tissue called the filum terminale which runs inferiorly from the bottom of the spinal cord This tethered condition can be treated by surgical section of the filum terminale More recently the concept of an occult tethered cord syndrome OTCS has been proposed in OTCS clinical symptoms eg incontinence are consistent with a tethered cord syndrome but the conus ends at a normal location The concept of the OTCS is controversial and it is not yet clear whether or not section of the filum is appropriate Filum section is a relatively minor procedure akin to appendectomy that requires general anesthesia during day surgery In uncontrolled case series section of the filum terminale in children with OTCS resulted in a 60-97 improvement in symptoms
Given this evidence that section of the filum may improve incontinence symptoms urologists are keen to refer more patients to neurosurgeons Furthermore families are demanding more tests and options and are ready to pursue surgery as treatment of their childs incontinence This suggests that the referral rate to Neurosurgery will continue to increase and there will be a crucial requirement to develop standard policies and procedures related to offering this surgery to children with incontinence As yet however the effectiveness and appropriateness of the surgery have not been evaluated systematically
To investigate this matter a comparison will be made between two randomized groups One group will undergo early tethered cord release by section of the filum terminale through a limited posterior lumbar spinal exposure and continued medical therapy for 12 months This group will be compared to a second that has continued standard medical therapy without surgical intervention for a further 12 months This comparison will be made based on physiological markers of urinary incontinence as measured by a urodynamic scale and quality of life as measured by a validated enuresis-specific quality of life scale The intervention will be considered to be successful if it improves the urodynamic score by 20 and the quality of life of the child and his family are significantly improved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None