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

NCT ID: NCT03478813

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-05-31

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.

Conditions

Daytime Wetting; Enuresis; Functional Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Voiding school

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turku

OTHER

Sponsor Role: collaborator

Southern Health and Social Care Trust

OTHER_GOV

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anneli Saarikoski

MNSc, RN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anneli Saarikoski

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Child welfare clinics

Helsinki, , Finland

Countries

Finland

Other Identifiers

Voiding School

Identifier Type: -

Identifier Source: org_study_id