No registrations found.
ID
Source
Brief title
Health condition
Dysfunctional voiding.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Internal consistency is the main study endpoint. Total scores of the patient and control group will be used to determine this endpoint.
Secondary outcome
For 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
Background summary
Children 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.
Study objective
To validate the Vancouver Symptom Score for Dysfunctional Elimination Syndrome in Dutch.
Study design
Patient group: baseline, 1 week after baseline, and after treatment.
Control group: baseline only
Intervention
Not applicable: study is observational.
L.A. Hoen, 't
Dept. Urology, room Na-17
Erasmus MC
Wytemaweg 80
Rotterdam 3015 CN
The Netherlands
010 - 703 65 59
l.thoen@erasmusmc.nl
L.A. Hoen, 't
Dept. Urology, room Na-17
Erasmus MC
Wytemaweg 80
Rotterdam 3015 CN
The Netherlands
010 - 703 65 59
l.thoen@erasmusmc.nl
Inclusion criteria
Patient 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4529 |
| NTR-old | NTR4664 |
| Other | METC 2014-290 : OZBS62.14018 |