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

Primary Purpose

Micturition Disorder

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Questionnaire and micturition and drinking diaries

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

Adaptation of the drinking scheme

Anticholinergic therapy

Micturition clock

About this trial

This is an interventional treatment trial for Micturition Disorder

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children with a motoric and/or mental disability 4-14 years Exclusion Criteria: Known neurogenic bladder disorder

Sites / Locations

University Hospital Ghent

Outcomes

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

Full Information

NCT ID

NCT00148005

First Posted

September 6, 2005

Last Updated

December 19, 2007

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT00148005

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Micturition Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

250 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Questionnaire and micturition and drinking diaries

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Type

Behavioral

Intervention Name(s)

Adaptation of the drinking scheme

Intervention Type

Drug

Intervention Name(s)

Anticholinergic therapy

Intervention Type

Behavioral

Intervention Name(s)

Micturition clock

Primary Outcome Measure Information:

Title

Prevalence of micturition disorders

Title

Etiology of micturition disorders after 10 weeks observation

Title

Influence of drinking scheme on bladder capacity and micturition continence after 10 weeks observation

Secondary Outcome Measure Information:

Title

Efficacy of the therapy after 3, 6, 9, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Children with a motoric and/or mental disability 4-14 years Exclusion Criteria: Known neurogenic bladder disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erik Van Laecke, MD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Links:

URL

http://www.uzgent.be

Description

Website University Hospital Ghent

Learn more about this trial

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

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