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

NCT ID: NCT00148005

Last Updated: 2007-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Micturition Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Questionnaire and micturition and drinking diaries

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Adaptation of the drinking scheme

Intervention Type BEHAVIORAL

Anticholinergic therapy

Intervention Type DRUG

Micturition clock

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children with a motoric and/or mental disability
* 4-14 years

Exclusion Criteria

* Known neurogenic bladder disorder
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Principal Investigators

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Erik Van Laecke, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2003/267

Identifier Type: -

Identifier Source: org_study_id