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

NCT03478813 | Withdrawn

• 1 other identifier: Voiding School
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Daytime Wetting; Enuresis; Functional Incontinence

Keywords

Intervention; Implementation; Children; Urotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in symptoms accosiated with incontinence

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

• Changes in quality of life

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

Other Outcomes (1)

• Questionnaire of the background information of the child

  at baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

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.

Interventions

Voiding school BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Turku: collaborator
• Southern Health and Social Care Trust: collaborator

Study Sites (1)

Child welfare clinics

Helsinki, Finland

Location

MeSH Terms

Conditions

Diurnal Enuresis; Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Anneli Saarikoski

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MNSc, RN

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: January 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)