Urinary Incontinence Clinical Trial
Official title:
Treatment of Persistent Urinary Incontinence in Children
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 within/at 12 months after treatment.
Eight % to sixteen % of school-aged children or approximately 50,000 children in British
Columbia (BC) suffer from persistent urinary incontinence (i.e., 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 and/or prescription use. Each year in BC, family
doctors refer about 4500 children to pediatric urologists at BC Children's 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 (e.g., 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 child's
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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