Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale (NICNOC)

A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus

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.

Study Overview

• Status: Terminated
• Conditions: Dysfunctional Voiding; Neurogenic Incontinence
• Intervention / Treatment: Procedure: Division of the filum terminal

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • A I duPont Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 medullaris of the spinal cord is at a normal position and that there is no other significant dysraphic lesion present. The entry criteria are designed to separate this very specific subset of patients from the much larger, more general group of children presenting for evaluation and management of incontinence.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in a 24-hour voiding log	6-month follow up
Change from baseline in the Dysfunctional Voiding Symptom Scale	6-month follow up
Change from baseline urodynamic testing	6-month follow up

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: October 26, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (ESTIMATE): November 6, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 16, 2015
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: incontinence; dysfunctional voiding; neurogenic bladder disturbance; filum terminale; spinal cord tethering; conus
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urinary Bladder, Neurogenic
• Other Study ID Numbers: 228683