Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2025-12-26 @ 1:54 AM
Study NCT ID:
NCT00148005
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014555', 'term': 'Urination Disorders'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D014554', 'term': 'Urination'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'lastUpdateSubmitDate': '2007-12-19', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of micturition disorders'}, {'measure': 'Etiology of micturition disorders after 10 weeks observation'}, {'measure': 'Influence of drinking scheme on bladder capacity and micturition continence after 10 weeks observation'}], 'secondaryOutcomes': [{'measure': 'Efficacy of the therapy after 3, 6, 9, 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Micturition Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': 'Investigation of the prevalence etiology and therapy of micturition disorders of children with a mental and/or motoric disability', 'detailedDescription': '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.\n\nInvestigation of the etiology by clinical and functional examination (uroflowmetry, bladder scan, video-urodynamic examination).\n\nFrequency:\n\n* Uroflowmetry: two periods of two weeks, with 6 weeks break between both periods. During the follow-up period every 3 months during 12 months\n* Bladder scan: once during the periods of the uroflowmetry\n* Video-urodynamic examination: once in selected participants, after consent of the parents\n* Adaptation of the drinking behaviour: start after two weeks of observation, after uroflowmetry and bladder scan. Continuous proces.\n* Therapeutic measures (medication, miction clock): start after 10 weeks of observation or after video-urodynamic examination.\n\nDevelopment of a therapeutic plan: adaptation of the micturition and drinking behaviour, anticholinergic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with a motoric and/or mental disability\n* 4-14 years\n\nExclusion Criteria:\n\n* Known neurogenic bladder disorder'}, 'identificationModule': {'nctId': 'NCT00148005', 'briefTitle': 'Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability', 'orgStudyIdInfo': {'id': '2003/267'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire and micturition and drinking diaries', 'type': 'PROCEDURE'}, {'name': 'Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination)', 'type': 'PROCEDURE'}, {'name': 'Adaptation of the drinking scheme', 'type': 'BEHAVIORAL'}, {'name': 'Anticholinergic therapy', 'type': 'DRUG'}, {'name': 'Micturition clock', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Erik Van Laecke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}}}}