Clinical trial NCT01465581: Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale
Official title: A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neurogenic Incontinence
Dysfunctional Voiding
Keywords: incontinence
dysfunctional voiding
neurogenic bladder disturbance
filum terminale
spinal cord tethering
conus
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life
timeFrame: 6-month follow up
Secondary outcomes:
measure: Change from baseline in a 24-hour voiding log
timeFrame: 6-month follow up
measure: Change from baseline in the Dysfunctional Voiding Symptom Scale
timeFrame: 6-month follow up
measure: Change from baseline urodynamic testing
timeFrame: 6-month follow up
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: A I duPont Hospital for Children
state: Delaware
Study officials:
affiliation: Alfred I. duPont Hospital for Children
name: Joseph H Piatt, MD
role: PRINCIPAL_INVESTIGATOR
References: