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Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
This study has been completed.
Sponsored by: University Hospital, Ghent
Information provided by: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00148005
  Purpose

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


Condition Intervention
Micturition Disorder
Procedure: Questionnaire and micturition and drinking diaries
Procedure: Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination)
Behavioral: Adaptation of the drinking scheme
Drug: Anticholinergic therapy
Behavioral: Micturition clock

MedlinePlus related topics: Urine and Urination
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Efficacy of the therapy after 3, 6, 9, 12 months

Estimated Enrollment: 250
Study Start Date: September 2004
Detailed Description:

Overview of the problem by a questionnaire, diary of micturition and drinking behaviour, filled out by the parents or by the staff of the institution.

Investigation of the etiology by clinical and functional examination (uroflowmetry, bladder scan, video-urodynamic examination).

Frequency:

  • Uroflowmetry: two periods of two weeks, with 6 weeks break between both periods. During the follow-up period every 3 months during 12 months
  • Bladder scan: once during the periods of the uroflowmetry
  • Video-urodynamic examination: once in selected participants, after consent of the parents
  • Adaptation of the drinking behaviour: start after two weeks of observation, after uroflowmetry and bladder scan. Continuous proces.
  • Therapeutic measures (medication, miction clock): start after 10 weeks of observation or after video-urodynamic examination.

Development of a therapeutic plan: adaptation of the micturition and drinking behaviour, anticholinergic therapy.

  Eligibility

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with a motoric and/or mental disability
  • 4-14 years

Exclusion Criteria:

  • Known neurogenic bladder disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148005

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Erik Van Laecke, MD University Hospital, Ghent
  More Information

Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

Study ID Numbers: 2003/267
Study First Received: September 6, 2005
Last Updated: December 19, 2007
ClinicalTrials.gov Identifier: NCT00148005  
Health Authority: Belgium: Institutional Review Board

Study placed in the following topic categories:
Urologic Diseases
Urination Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009