Treatment of Persistent Urinary Incontinence in Children
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

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 within/at 12 months
      after treatment.
    

Detailed description: 
      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.
    

Intervention name(s): Surgery; Medical Treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgery for this diagnosis is a standard of care, as is the medical treatment. We are comparing the two; Surgery for this diagnosis is a standard of care, as is the medical treatment. We are comparing the two
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary Incontinence in Children; Surgical Section of the Filum Terminale; Occult Tethered Cord Syndrome; Urodynamic Scale; Enuresis-Specific Quality of Life Scale