Dysfunctional Voiding Clinical Trial
— NICNOCOfficial title:
A Prospective Trial of Division of the Filum Terminale for Neurogenic Bladder Dysfunction With a Normal Conus
Verified date | November 2011 |
Source | Nemours Children's Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 5 Years to 16 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | A I duPont Hospital for Children | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Nemours Children's Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life | 6-month follow up | No | |
Secondary | Change from baseline in a 24-hour voiding log | 6-month follow up | No | |
Secondary | Change from baseline in the Dysfunctional Voiding Symptom Scale | 6-month follow up | No | |
Secondary | Change from baseline urodynamic testing | 6-month follow up | No |
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