NCT00124046

Brief Summary

The purpose of this study is to determine whether surgical section of the filum terminale in children, when added to standard medical therapy, will result in a reliable and clinically-significant improvement in two main markers of incontinence within/at 12 months after treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

9.3 years

First QC Date

July 22, 2005

Last Update Submit

May 30, 2016

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence in ChildrenSurgical Section of the Filum TerminaleOccult Tethered Cord SyndromeUrodynamic ScaleEnuresis-Specific Quality of Life Scale

Outcome Measures

Primary Outcomes (1)

  • Quality of life, as measured by a validated enuresis-specific quality of life scale

Secondary Outcomes (5)

  • Any of the following radiographic findings leads to improved response to section of the filum: fat in the filum terminale, thickened filum terminale, presence of bifid lamina

  • Presence of a growth spurt in the 6 months following the section of the filum compared to the 6 months prior

  • Duration of urinary symptoms is negatively associated with improvement in urinary function

  • The following subtle neurological abnormalities are predictors of good outcome following filum section: strength or sensory dysfunction, clinical symptoms of back or leg pain, inability to touch toes with forward flexion

  • Section of the filum terminale leads to reduced frequency of urinary infections in the 12 months following surgery

Study Arms (2)

Surgical

ACTIVE COMPARATOR
Procedure: Surgery

Medical Treatment

ACTIVE COMPARATOR
Procedure: Medical Treatment

Interventions

SurgeryPROCEDURE

Surgery for this diagnosis is a standard of care, as is the medical treatment. We are comparing the two

Surgical
Medical TreatmentPROCEDURE

Surgery for this diagnosis is a standard of care, as is the medical treatment. We are comparing the two

Medical Treatment

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primary or secondary daytime urinary incontinence, persistent over 12 months of medical treatment
  • An abnormal 3 day voiding diary compiled over a 3 week voiding period completed after 12 months of medical treatment
  • Normal bladder ultrasound (if bladder ultrasound shows more than minimal bladder thickening \[\>3.0mm at 50% filling of expected capacity or less\] then a voiding cystourethrogram \[VCUG\] will be required to rule out bladder outlet obstruction)
  • Abnormal urodynamic testing
  • Normal position conus medullaris
  • Any size filum terminale
  • Any amount of fat in the filum terminale
  • Terminal syringomyelia of less than one bony level is acceptable
  • Lumbar bifid spinal lamina is acceptable

You may not qualify if:

  • Patients with evidence of significant, progressive, lower extremity motor or sensory deficits, with evidence of progression over the previous 6 months
  • The presence of cutaneous markings on the back, in the absence of confirmatory magnetic resonance imaging (MRI) findings of a specific spinal dysraphism does not exclude the patient from participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's and Women's Health Centre of British Columbia

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (1)

  • Steinbok P, MacNeily AE, Hengel AR, Afshar K, Landgraf JM, Hader W, Pugh J. Filum Section for Urinary Incontinence in Children with Occult Tethered Cord Syndrome: A Randomized, Controlled Pilot Study. J Urol. 2016 Apr;195(4 Pt 2):1183-8. doi: 10.1016/j.juro.2015.09.082. Epub 2016 Feb 28.

    PMID: 26926544DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Steinbok, MB, BS, FRCSC

    Children's and Women's Health Centre of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2005

First Posted

July 26, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2014

Study Completion

October 1, 2015

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

CA(1)