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WithdrawnNCT03478813Updated May 26, 2021

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

An interventional study of Voiding school in Daytime Wetting, Enuresis and Functional Incontinence, sponsored by Helsinki University Central Hospital. Withdrawn at 1 site in Finland. Open to participants aged 5 Years to 6 Years. Per ClinicalTrials.gov, last updated 2021-05-26.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The study was withdrawn because of too few eligible participants.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
5 Years to 6 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Daytime Wetting
  • Enuresis
  • Functional Incontinence

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Keywords

  • Intervention
  • Implementation
  • Children
  • Urotherapy
03

In context

Enuresis

31 studies on the registry are indexed under Enuresis; 2 are open to participants now.

Browse Enuresis studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • No specified exclusion criteria were set.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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.

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.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

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

  2. 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).

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

Other outcomes

  1. 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.

    Time frame: at baseline

07

Study locations

1 site
  • Child welfare clinics
    Helsinki, Finland
08

References and documents

Individual participant data

Plan to share: No — The data will be reported in articles including in summary of master thesis

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in May 2019, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2018
First posted
Mar 27, 2018
StartActual
Jan 1, 2018
Primary completionActual
May 31, 2019
CompletionActual
May 31, 2019
Last update
May 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03478813
Collaborators
University of Turku, Southern Health and Social Care Trust
Responsible party
Anneli Saarikoski (MNSc, RN, Helsinki University Central Hospital) — Principal investigator
First posted
Mar 27, 2018
Start date
Jan 1, 2018
Primary completion
May 31, 2019
Completion
May 31, 2019
Last update
May 26, 2021

Study contacts

Anneli Saarikoski
principal investigator · Helsinki University Central Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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