Micturition DisorderNCT00148005
Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
A study testing Questionnaire and micturition and drinking diaries, Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination) and Adaptation of the drinking scheme in people with Micturition Disorder, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Investigation of the prevalence etiology and therapy of micturition disorders of children with a mental and/or motoric disability Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Micturition Disorder
- What is being tested?
- Questionnaire and micturition and drinking diaries, Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination) and Adaptation of the drinking scheme
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2004to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a motoric and/or mental disability
- 4-14 years
Who cannot join
- Known neurogenic bladder disorder
Trial locations and contacts
1 site in 1 country.
About this study
Investigation of the prevalence etiology and therapy of micturition disorders of children with a mental and/or motoric disability
Read the 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.
- Conditions
- Micturition Disorder
- Being tested
- 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
- Medical subject headings
- Urination Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and micturition and drinking diariesProcedure or surgery
Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination)Procedure or surgery
Adaptation of the drinking schemeBehavioural
Anticholinergic therapyDrug
Micturition clockBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Efficacy of the therapy after 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Micturition DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Erik Van Laecke, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148005
- Sponsor's protocol ID
- 2003/267
- Status last verified
- Dec 2007
- First submitted
- 6 Sep 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
- ClinicalTrials.gov ID
- NCT00148005
- Acronym / sponsor ID
- 2003/267
- Conditions
- Micturition Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2004
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with a motoric and/or mental disability
- 4-14 years
Key exclusion criteria (1 listed)
- Known neurogenic bladder disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and micturition and drinking diaries | Procedure or surgery | – |
| Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination) | Procedure or surgery | – |
| Adaptation of the drinking scheme | Behavioural | – |
| Anticholinergic therapy | Drug | – |
| Micturition clock | Behavioural | – |
Primary outcome
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
1 secondary outcome
Efficacy of the therapy after 3, 6, 9, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
- Website University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Van Laecke, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and micturition and drinking diaries, Clinical and functional examination (uroflowmetry, bladder scan and video-urodynamic examination) and Adaptation of the drinking scheme in people with Micturition Disorder, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of micturition disorders. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2007.