Clinical trial NCT03478813: Voiding School as a Treatment of Children's Day-time Incontinence or Enuresis
Official title: Voiding School as a Treatment of Children's Functional Incontinence - Evaluation and Implementation of the Intervention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Daytime Wetting
Enuresis
Functional Incontinence
Keywords: Intervention
Implementation
Children
Urotherapy
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Turku
name: Southern Health and Social Care Trust
First posted: 2018-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel randomized trial conducted in 9 Child welfare clinics in one City in southern Finland. The study subjects are randomly allocated into intervention and control groups.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Children under school age attend to regular visits in Child welfare clinics for health examination and guidance. If the child have daytime incontinence or enuresis during the yearly visit at the age of 5 or 6, he or she is eligible for participating the study aiming to implement and evaluate the Voiding school intervention.

In the Voiding school the children are educated in groups of 4-6 children with child-oriented methods highlighting learning by doing in order to achieve better bladder control. Usual care includes individual advice concerning voiding habits and general life-style advice.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in wetting episodes
timeFrame: at baseline, after intervention (3 months), follow-up 6 months after baseline
Secondary outcomes:
measure: Changes in symptoms accosiated with incontinence
timeFrame: at baseline, after intervention (3 months), follow-up 6 months after baseline
measure: Changes in quality of life
timeFrame: at baseline, after intervention (3 months), follow-up 6 months after baseline
Other outcomes:
measure: Questionnaire of the background information of the child
timeFrame: at baseline
Locations:
city: Helsinki
country: Finland
facility: Child welfare clinics
Study officials:
affiliation: Helsinki University Central Hospital
name: Anneli Saarikoski
role: PRINCIPAL_INVESTIGATOR
References: