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Clinical Trials/NCT03478813
NCT03478813
Withdrawn
N/A

Voiding School as a Treatment of Children's Functional Incontinence - Evaluation and Implementation of the Intervention

Helsinki University Central Hospital1 site in 1 countryJanuary 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Daytime Wetting
Sponsor
Helsinki University Central Hospital
Locations
1
Primary Endpoint
Changes in wetting episodes
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
May 31, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anneli Saarikoski

MNSc, RN

Helsinki University Central Hospital

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.

Outcomes

Primary Outcomes

Changes in wetting episodes

Time Frame: at baseline, after intervention (3 months), follow-up 6 months after baseline

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.

Secondary Outcomes

  • Changes in quality of life(at baseline, after intervention (3 months), follow-up 6 months after baseline)
  • Changes in symptoms accosiated with incontinence(at baseline, after intervention (3 months), follow-up 6 months after baseline)

Study Sites (1)

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