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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Nemours Children's Clinic.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01465581
First received: October 26, 2011
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Neurogenic Incontinence
Dysfunctional Voiding
Procedure: Division of the filum terminal

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus

Resource links provided by NLM:


Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in a 24-hour voiding log [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
  • Change from baseline in the Dysfunctional Voiding Symptom Scale [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
  • Change from baseline urodynamic testing [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: July 2011
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465581

Locations
United States, Delaware
A I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Joseph H Piatt, MD    302-651-5994    jpiatt@nemours.org   
Principal Investigator: Joseph H Piatt, MD         
Sub-Investigator: Jennifer Hagerty, DO         
Sub-Investigator: Ernesto Figueroa, MD         
Sub-Investigator: Ahmad Bani Hani, MD         
Sub-Investigator: Julia Barthold, MD         
Sub-Investigator: Jeffrey Campbell, MD         
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
Principal Investigator: Joseph H Piatt, MD Alfred I. duPont Hospital for Children
  More Information

No publications provided

Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01465581     History of Changes
Other Study ID Numbers: 228683
Study First Received: October 26, 2011
Last Updated: November 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Nemours Children's Clinic:
incontinence
dysfunctional voiding
neurogenic bladder disturbance
filum terminale
spinal cord tethering
conus

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014