Enuresis Clinical Trial
Official title:
Voiding School as a Treatment of Children's Functional Incontinence - Evaluation and Implementation of the Intervention
Verified date | May 2021 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Voiding School is a simple educational intervention to treat children with daytime incontinence or enuresis.The purpose of this study is to implement the intervention in primary care, child welfare clinics. Half of the participated children will receive treatment according the Voiding School protocoll and half of them will receive treatment as usual. Patient outcomes are evaluated by measuring changes in wetting episodes. Aim is also to evaluate the implementation process.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 6 Years |
Eligibility | Inclusion Criteria: - The child is eligible for participating the study, if he or she has day-time incontinence or enuresis weekly, provided that following inclusion criteria are met: 1) there is no organic cause for incontinence, 2) he or she have no diagnosed behavioral disorders, and 3) the child and the parents are able to communicate in Finnish. Exclusion Criteria: - No specified exclusion criteria were set. |
Country | Name | City | State |
---|---|---|---|
Finland | Child welfare clinics | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | Southern Health and Social Care Trust, University of Turku |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Questionnaire of the background information of the child | Background information of the participated children (age, sex, dg, duration of incontinence, earlier treatment, constipation) is collected with developed questionnaire. | at baseline | |
Primary | Changes in wetting episodes | Changes of amount of dry days and nights, is performed with the modified Finnish version of the ICCS one-week voiding diary (©2015 International Children's Continence Society). Children with the help of their parents are asked to mark X in the diary every time they are voiding; M=a little amount of wetting, MM=a bigger amount of wetting, Y=night-time wetting. Bowel movements are marked with K. | at baseline, after intervention (3 months), follow-up 6 months after baseline | |
Secondary | Changes in symptoms accosiated with incontinence | Symptom score for dysfunctional elimination syndrome (NLUT-DES questionnaire) is used to evaluate children's voiding and defecation habits associated with incontinence. It is a 14-item 5-point Likert scale questionnaire (0=no symptoms 4=severe symptoms, except item 3: 0=5-6 times, 2= 3-4 or 7-8 times, 4= 1-2 or over 8 times). Official translation into Finnish was performed for this study. | at baseline, after intervention (3 months), follow-up 6 months after baseline | |
Secondary | Changes in quality of life | Quality of life of 5-6 years old children with incontinence is measured with Finnish version of Pediatric Quality of Life Inventory (PedsQL™ 4.0) Used version is intended for parents of 5-7 years old children. Generic score scales (physical, emotional, social, school functioning) consist of 21-item 5-point Likert scale (0=never 4=always). | at baseline, after intervention (3 months), follow-up 6 months after baseline |
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