- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00148005
Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ghent, Belgium, 9000
- University Hospital Ghent
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children with a motoric and/or mental disability
- 4-14 years
Exclusion Criteria:
- Known neurogenic bladder disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Prevalence of micturition disorders
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Etiology of micturition disorders after 10 weeks observation
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Influence of drinking scheme on bladder capacity and micturition continence after 10 weeks observation
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Secondary Outcome Measures
Outcome Measure |
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Efficacy of the therapy after 3, 6, 9, 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erik Van Laecke, MD, University Hospital, Ghent
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003/267
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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