Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale

NCT ID: NCT01465581

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-04-30

Brief 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.

Conditions

Neurogenic Incontinence; Dysfunctional Voiding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Division of the filum terminal

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph H Piatt, MD

Role: PRINCIPAL_INVESTIGATOR

Alfred I. duPont Hospital for Children

Locations

A I duPont Hospital for Children

Wilmington, Delaware, United States

Countries

United States

Other Identifiers

228683

Identifier Type: -

Identifier Source: org_study_id