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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:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00148005
First received: September 6, 2005
Last updated: December 19, 2007
Last verified: December 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   4 Years to 14 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00148005     History of Changes
Other Study ID Numbers: 2003/267
Study First Received: September 6, 2005
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014