NCT02364063

Brief Summary

This study evaluates the effectiveness of a voiding reeducation program as treatment for incontinence in children with a brain injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration 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

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

February 9, 2015

Last Update Submit

January 3, 2017

Conditions

Daytime Urinary Incontinence

Keywords

Urinary incontinencecerebral palsyurotherapychild

Outcome Measures

Primary Outcomes (1)

  • Subjective report of change in urinary incontinence measured by questionnaire

    Baseline and 3-6-12 months + follow-up

Secondary Outcomes (4)

  • Lower urinary tract symptoms (LUTS) measured by questionnaire

    baseline and 6-12 months

  • Drinking behaviour measured by drinking and voiding charts

    Baseline and 6-12 months

  • Constipation/fecal incontinence measured by ROME III criteria

    Baseline and 6-12 months

  • voiding variables and pelvic floor activity during micturition measured by uroflow/EMG

    Baseline and 3-6-12 months

Study Arms (3)

Children with CP - Therapy

EXPERIMENTAL

Children receive incontinence treatment during one year, after which a follow-up period of 6 months will be applied. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy

Other: urotherapy with or without pharmacotherapy

Children with CP - Control

NO INTERVENTION

Children are followed for 6 months, not receiving any treatment. After this follow-up period, children also receive incontinence treatment for 6 months.

Children without CP

ACTIVE COMPARATOR

Children receive incontinence treatment during 1 year. Intervention includes standard urotherapy with or without pharmacotherapy/specific urotherapy

Other: urotherapy with or without pharmacotherapy

Interventions

urotherapy with or without pharmacotherapyOTHER

Individualized

Children with CP - TherapyChildren without CP

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Daytime urinary incontinence with or without enuresis and/or fecal incontinence
  • Cerebral palsy (Arms of children with CP)
  • Normal development (Arms of children without CP)

You may not qualify if:

  • Isolated urinary tract infections
  • Isolated enuresis
  • Isolated dysfunctional voiding
  • Isolated fecal incontinence
  • Anatomical abnormalities
  • History of genitourinary or renal surgery
  • Medication for incontinence during the last 3 months
  • Pelvic reeducation during the last 6 months
  • other neurologic problems influencing continence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

  • Samijn B, Van den Broeck C, Plasschaert F, Pascal A, Deschepper E, Hoebeke P, Van Laecke E. Incontinence training in children with cerebral palsy: A prospective controlled trial. J Pediatr Urol. 2022 Aug;18(4):447.e1-447.e9. doi: 10.1016/j.jpurol.2022.05.014. Epub 2022 May 25.

    PMID: 35732572DERIVED

MeSH Terms

Conditions

Diurnal EnuresisUrinary IncontinenceCerebral Palsy

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental DisordersLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Erik Van Laecke, PhD MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 16, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

BE(1)