Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
Primary Purpose
Micturition Disorder
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Questionnaire and micturition and drinking diaries
Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination)
Adaptation of the drinking scheme
Anticholinergic therapy
Micturition clock
Sponsored by
About this trial
This is an interventional treatment trial for Micturition Disorder
Eligibility Criteria
Inclusion Criteria: Children with a motoric and/or mental disability 4-14 years Exclusion Criteria: Known neurogenic bladder disorder
Sites / Locations
- University Hospital Ghent
Outcomes
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
Full Information
NCT ID
NCT00148005
First Posted
September 6, 2005
Last Updated
December 19, 2007
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00148005
Brief Title
Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
Official Title
Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigation of the prevalence etiology and therapy of micturition disorders of children with a mental and/or motoric disability
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Micturition Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Questionnaire and micturition and drinking diaries
Intervention Type
Procedure
Intervention Name(s)
Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination)
Intervention Type
Behavioral
Intervention Name(s)
Adaptation of the drinking scheme
Intervention Type
Drug
Intervention Name(s)
Anticholinergic therapy
Intervention Type
Behavioral
Intervention Name(s)
Micturition clock
Primary Outcome Measure Information:
Title
Prevalence of micturition disorders
Title
Etiology of micturition disorders after 10 weeks observation
Title
Influence of drinking scheme on bladder capacity and micturition continence after 10 weeks observation
Secondary Outcome Measure Information:
Title
Efficacy of the therapy after 3, 6, 9, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with a motoric and/or mental disability
4-14 years
Exclusion Criteria:
Known neurogenic bladder disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Van Laecke, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
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