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

Enuresis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03478813
• Other study ID #: Voiding School
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn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.

Related Conditions & MeSH terms

• Daytime Wetting
• Diurnal Enuresis
• Enuresis
• Functional Incontinence
• Nocturnal Enuresis
• Urinary Incontinence

Intervention

Behavioral:
• Voiding 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.

Locations

Country	Name	City	State
Finland	Child welfare clinics	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Southern Health and Social Care Trust, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

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