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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148005
First Posted: September 7, 2005
Last Update Posted: December 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Ghent
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00148005     History of Changes
Other Study ID Numbers: 2003/267
First Submitted: September 6, 2005
First Posted: September 7, 2005
Last Update Posted: December 28, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Disease
Urination Disorders
Pathologic Processes
Urologic Diseases
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs