Treatment of Neurogenic Incontinence by Surgery to Cut the Filum Terminale

Terminated

• Conditions: Neurogenic Incontinence; Dysfunctional Voiding
• Interventions: Procedure: Division of the filum terminal

• Registration Number: NCT01465581
• Lead Sponsor: Nemours Children's Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-10-26
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-06
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neurogenic incontinence	Division of the filum terminal	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 of the spinal cord is at a normal position and that there is no other significant dysraphic lesion present.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Pediatric Enuresis Module to Assess Quality of Life	6-month follow up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

A I duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States