NCT00148005

Brief Summary

Investigation of the prevalence etiology and therapy of micturition disorders of children with a mental and/or motoric disability

Trial Health

80
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at 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

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

September 6, 2005

Last Update Submit

December 19, 2007

Conditions

Micturition Disorder

Outcome Measures

Primary Outcomes (3)

  • Prevalence of micturition disorders

  • Etiology of micturition disorders after 10 weeks observation

  • Influence of drinking scheme on bladder capacity and micturition continence after 10 weeks observation

Secondary Outcomes (1)

  • Efficacy of the therapy after 3, 6, 9, 12 months

Interventions

Questionnaire and micturition and drinking diariesPROCEDURE
Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination)PROCEDURE
Adaptation of the drinking schemeBEHAVIORAL
Anticholinergic therapyDRUG
Micturition clockBEHAVIORAL

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with a motoric and/or mental disability
  • years

You may not qualify if:

  • Known neurogenic bladder disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Urination Disorders

Interventions

Surveys and QuestionnairesUrination

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Erik Van Laecke, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

September 1, 2004

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

BE(1)