Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale

Dysfunctional Voiding Clinical Trial

— NICNOC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01465581
• Other study ID #: 228683
• Status: Terminated
• Phase: N/A
• First received: October 26, 2011
• Last updated: April 16, 2015
• Start date: July 2011
• Est. completion date: April 2014

Study information

• Verified date: November 2011
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dysfunctional Voiding
• Neurogenic Incontinence

Intervention

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.

Locations

Country	Name	City	State
United States	A I duPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life		6-month follow up	No
Secondary	Change from baseline in a 24-hour voiding log		6-month follow up	No
Secondary	Change from baseline in the Dysfunctional Voiding Symptom Scale		6-month follow up	No
Secondary	Change from baseline urodynamic testing		6-month follow up	No