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NEDERLANDS





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Het toetsen van een vragenlijst voor kinderen met plasproblemen in het Nederlands.


- candidate number18260
- NTR NumberNTR4664
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jul-2014
- Secondary IDsOZBS62.14018 METC 2014-290
- Public TitleHet toetsen van een vragenlijst voor kinderen met plasproblemen in het Nederlands.
- Scientific TitleValidation of the Vancouver Symptom Score for Dysfunctional Elimination Syndrome in Dutch
- ACRONYMVancouver SSDES validation in Dutch
- hypothesisTo validate the Vancouver Symptom Score for Dysfunctional Elimination Syndrome in Dutch.
- Healt Condition(s) or Problem(s) studiedDysfunctional voiding
- Inclusion criteriaPatient group:
Male or female children aged 6 16 years
Has DV
Child and at least one parent fluent in the Dutch language
Signed informed consent

Control group:
Male or female children aged 6 16 years
Has no urinary tract symptoms
Child and at least one parent fluent in the Dutch language
Signed informed consent
- Exclusion criteria Has a neurogenic disease
Has anatomic abnormalities of the urinary tract
Has received previous urological surgery
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-aug-2014
- planned closingdate1-aug-2015
- Target number of participants100
- InterventionsNot applicable: study is observational.
- Primary outcomeInternal consistency is the main study endpoint. Total scores of the patient and control group will be used to determine this endpoint.
- Secondary outcomeFor the following secondary endpoint scores from patient and control group will be used:
Construct validity

For the following secondary endpoints scores from the patient group will be used:
Reproducibility
Content validity
Responsiveness
Interpretability
- TimepointsPatient group: baseline, 1 week after baseline, and after treatment.

Control group: baseline only
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs L.A. Hoen, 't
- CONTACT for SCIENTIFIC QUERIESDrs L.A. Hoen, 't
- Sponsor/Initiator Erasmus Medical Center, Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryChildren with dysfunctional voiding suffer from both urinary and bowel symptoms. A scoring system to quantify these symptoms and detect improvement is the Vancouver symptom score for dysfunctional elimination syndrome. This questionnaire enables us to assess the effectiveness of treatment in children with dysfunctional voiding.

Children with dysfunctional voiding are asked to fill out the Vancouver SSDES at three time-points. They are also asked to fill out an extra questionnaire at two time-points, in order to validate the Vancouver SSDES. They will also be asked to fill out a voiding diary for two days at two time points, which is part of standard care. Children in the control group are asked to fill out the two questionnaires only once. No extra outpatient visit is required. The questions in the questionnaires are similar to the medical history during an outpatient visit. The burden is therefore minimal for these children. Participation in this study will not influence patient treatment.
- Main changes (audit trail)
- RECORD2-jul-2014 - 1-aug-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl