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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01465581
Other study ID # 228683
Secondary ID
Status Terminated
Phase N/A
First received October 26, 2011
Last updated April 16, 2015
Start date July 2011
Est. completion date April 2014

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Division of the filum terminal
Division of the filum is performed through a 6cm incision over the lumbosacral junction that can be oriented either longitudinally or transversely - to be hidden beneath underclothes or swim wear. A single level laminectomy provides sufficient exposure. The dural opening can be as short as 1cm. Under the microscope the filum is identified visually and separated from lower sacral rootlets with the aid of microelectrode stimulation. When a segment of the filum has been excised and sent for laboratory examination, the dura is closed and reinforced with fibrin glue. The wound is closed in layers, and the patient is kept at bed rest horizontal for 2 nights to discourage CSF fistulization of the wound.

Locations

Country Name City State
United States A I duPont Hospital for Children Wilmington Delaware

Sponsors (1)

Lead Sponsor Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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Recruiting NCT06165731 - At-Home Diaphragmatic Interventions for Voiding Abnormalities (DIVA) N/A
Completed NCT06040333 - Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding N/A
Not yet recruiting NCT04147793 - Case Control Study to Investigate the Use of Urethral Pressure Profile Measurement in Children
Completed NCT05313984 - OptiLUTS Part C: The Development of a Symptom Assessment Tool in Sacral Neuromodulation.
Active, not recruiting NCT04490642 - Linguistic Validation of the Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ) for 5-12 Years Old in Korean
Completed NCT02806713 - The Effect of Oral PhenazopyrIdine on Perioperative Voiding After Mid-urethral sliNg (EPIPhANy Study) Phase 3