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Voiding School as a Treatment of Children's Day-time Incontinence or Enuresis

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03478813
Enrollment
0
Registered
2018-03-27
Start date
2018-01-01
Completion date
2019-05-31
Last updated
2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Daytime Wetting, Enuresis, Functional Incontinence

Keywords

Intervention, Implementation, Children, Urotherapy

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.

Interventions

BEHAVIORALVoiding school

Children are educated on the kidneys, bladder and bowel function, the importance of regular voiding and drinking habits, and avoidance of constipation. Balloons, books, videos, animations, the pictures of a satisfied and irritated bladder and a poo-cars formula track are used to exemplify the function of urinary and defecation systems. During toilet visits children are given advise about an adequate and relaxed toilet posture with the help of little bench under the feet if needed. Each child also make their own timetable for peeing, pooing, and water drinking times, which they then should learn to follow in day-care, pre-school and at home. At the end of each session child, parent and public health nurse/urotherapist discuss any individual advice and the homework for the next time.

Sponsors

University of Turku
CollaboratorOTHER
Southern Health and Social Care Trust
CollaboratorOTHER_GOV
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
5 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in wetting episodesat baseline, after intervention (3 months), follow-up 6 months after baselineChanges 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

MeasureTime frameDescription
Changes in symptoms accosiated with incontinenceat baseline, after intervention (3 months), follow-up 6 months after baselineSymptom 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.
Changes in quality of lifeat baseline, after intervention (3 months), follow-up 6 months after baselineQuality 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).

Other

MeasureTime frameDescription
Questionnaire of the background information of the childat baselineBackground information of the participated children (age, sex, dg, duration of incontinence, earlier treatment, constipation) is collected with developed questionnaire.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026