TerminatedNot Applicable

Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale

Stopped: Insufficient patient accrual.

United States5 participantsStarted 2011-07

Plain-language 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.

Who can participate

Age range5 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 6-month follow up

Trial details

NCT IDNCT01465581

SponsorNemours Children's Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-04

View on ClinicalTrials.gov More Neurogenic Incontinence trials