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

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.

Study Overview

• Status: Withdrawn
• Conditions: Enuresis; Daytime Wetting; Functional Incontinence
• Intervention / Treatment: Behavioral: Voiding school

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Child welfare clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; Voiding school (VS) is based on urotherapy guidelines for educating children with incontinence highlighting regular voiding habits and life-style advice. Learning by doing, understanding the body function by concrete example videos and pictures, and discussing are the main teaching methods.The intervention is delivered face-to-face in groups of 4-6 children. The VS includes three sessions one months apart. Duration of each VS session is three hours. The intervention is delivered with detailed manual. The intervention is provided by an urotherapist and a public-health nurse.	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.
NO_INTERVENTION: Usual care group; The control group receives treatment according to the new 2016 guidelines of incontinence care in child welfare clinics in the city concerning. Treatment is carried out by public health nurse individually in consulting hours or by telephone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Turku; Southern Health and Social Care Trust
• Investigators: Principal Investigator: Anneli Saarikoski, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): May 31, 2019
• Study Completion (ACTUAL): May 31, 2019

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (ACTUAL): March 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Implementation; Children; Intervention; Urotherapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Nocturnal Enuresis; Diurnal Enuresis
• Other Study ID Numbers: Voiding School

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be reported in articles including in summary of master thesis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No