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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT00148005
• Collaborator: (none)
• Enrollment: 250
• Location: 1

Study Details

Study Description

Brief Summary

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

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	N/A

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 Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
• Study Start Date: Sep 1, 2004

Outcome Measures

Primary Outcome Measures

1. Prevalence of micturition disorders []

2. Etiology of micturition disorders after 10 weeks observation []

3. Influence of drinking scheme on bladder capacity and micturition continence after 10 weeks observation []

Secondary Outcome Measures

1. Efficacy of the therapy after 3, 6, 9, 12 months []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children with a motoric and/or mental disability

• 4-14 years

Exclusion Criteria:

• Known neurogenic bladder disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Erik Van Laecke, MD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website University Hospital Ghent

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00148005
• Other Study ID Numbers: 2003/267
• First Posted: Sep 7, 2005
• Last Update Posted: Dec 28, 2007
• Last Verified: Dec 1, 2007

• Additional relevant MeSH terms: Urination Disorders; Cholinergic Antagonists

Study Results

No Results Posted as of Dec 28, 2007