Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability

Micturition Disorder Clinical Trial

Official title:

Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148005
• Other study ID #: 2003/267
• Status: Completed
• Phase: N/A
• First received: September 6, 2005
• Last updated: December 19, 2007
• Start date: September 2004

Study information

• Verified date: December 2007
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Investigation of the prevalence etiology and therapy of micturition disorders of children with a mental and/or motoric disability

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 14 Years

Eligibility

Inclusion Criteria:

• Children with a motoric and/or mental disability

• 4-14 years

Exclusion Criteria:

• Known neurogenic bladder disorder

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Micturition Disorder
• Urination Disorders

Intervention

Procedure:
• Questionnaire and micturition and drinking diaries

• Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination)

Behavioral:
• Adaptation of the drinking scheme

Drug:
• Anticholinergic therapy

Behavioral:
• Micturition clock

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of micturition disorders
Primary	Etiology of micturition disorders after 10 weeks observation
Primary	Influence of drinking scheme on bladder capacity and micturition continence after 10 weeks observation
Secondary	Efficacy of the therapy after 3, 6, 9, 12 months

External Links

•   Website University Hospital Ghent