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

Nemours Children's Health

Status: Terminated

Conditions: Dysfunctional Voiding; Neurogenic Incontinence

Treatments: Procedure: Division of the filum terminal

Study type: Observational

Funder types: Other

Identifiers

NCT01465581

228683

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 1 patient group

Neurogenic incontinence

Description:

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.

Treatment:

Procedure: Division of the filum terminal