Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale

Overview

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.

Full Title of Study: “A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2014

Interventions

  • 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.

Arms, Groups and Cohorts

  • Neurogenic incontinence
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life
    • Time Frame: 6-month follow up

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Primary or secondary daytime urinary incontinence, persistent over at least 6 months of medical treatment. – Abnormal urodynamic testing – Normal conus on magnetic resonance imaging of the spine – Dysfunctional Voiding Symptom Scale score greater than 6 for girls or greater than 9 for boys Exclusion Criteria:

  • Bladder outlet obstruction – Bladder atony – Congenital anorectal malformation – Additional diagnoses independently associated with neurogenic bladder dysfunction – Encephalopathy precluding reasonable expectation of attainment of continence – Inability to comply with medical management – Unwillingness to comply with initial or follow up urodynamic testing

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nemours Children’s Clinic
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joseph H Piatt, MD, Principal Investigator, Alfred I. duPont Hospital for Children

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