Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
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|ClinicalTrials.gov Identifier: NCT00148005|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : December 28, 2007
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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).
- 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 :||Interventional (Clinical Trial)|
|Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability|
|Study Start Date :||September 2004|
- 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
- Efficacy of the therapy after 3, 6, 9, 12 months
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
|University Hospital Ghent|
|Ghent, Belgium, 9000|
|Principal Investigator:||Erik Van Laecke, MD||University Hospital, Ghent|