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

Nemours Children's Clinic1 site in 1 country5 target enrollmentJuly 2011

ConditionsNeurogenic Incontinence Dysfunctional Voiding

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neurogenic Incontinence
Sponsor: Nemours Children's Clinic
Enrollment: 5
Locations: 1
Primary Endpoint: Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

April 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Nemours Children's Clinic

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life

Time Frame: 6-month follow up

Secondary Outcomes

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)