Daytime WettingNCT03478813
Voiding School as a Treatment of Children's Day-time Incontinence or Enuresis
A study testing Voiding school in people with Daytime Wetting and Enuresis, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Daytime Wetting, Enuresis, Functional Incontinence
- What is being tested?
- Voiding school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- No specified exclusion criteria were set.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Daytime Wetting, Enuresis, Functional Incontinence
- Being tested
- Voiding school
- Keywords
- Intervention, Implementation, Children, Urotherapy
- Medical subject headings
- Diurnal Enuresis, Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voiding schoolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, after intervention (3 months), follow-up 6 months after baseline
Secondary outcomes (2)
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.
Measured: 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).
Measured: at baseline, after intervention (3 months), follow-up 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Jan 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: The study was withdrawn because of too few eligible participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Daytime WettingStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, Southern Health and Social Care Trust
- Responsible party
- Principal investigator, Anneli Saarikoski, Helsinki University Central Hospital
- Investigators
- Anneli Saarikoski, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478813
- Sponsor's protocol ID
- Voiding School
- Status last verified
- May 2021
- First submitted
- 20 Mar 2018
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be reported in articles including in summary of master thesis
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voiding School as a Treatment of Children's Functional Incontinence - Evaluation and Implementation of the Intervention
- ClinicalTrials.gov ID
- NCT03478813
- Acronym / sponsor ID
- Voiding School
- Conditions
- Daytime Wetting, Enuresis, Functional Incontinence
- Keywords
- Intervention, Implementation, Children, Urotherapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn because of too few eligible participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Turku, Southern Health and Social Care Trust
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Voiding schoolVoiding 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. |
| 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. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- No specified exclusion criteria were set.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voiding schoolChildren 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. | Behavioural | Intervention group |
Primary outcome
Changes in wetting episodes
Time frame: at baseline, after intervention (3 months), follow-up 6 months after baseline
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.
2 secondary outcomes
Changes in symptoms accosiated with incontinence
Time frame: at baseline, after intervention (3 months), follow-up 6 months after baseline
Changes in quality of life
Time frame: at baseline, after intervention (3 months), follow-up 6 months after baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: No. The data will be reported in articles including in summary of master thesis
Related trials for Daytime Wetting
RecruitingPhase 3
Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
Urinary Incontinence in Children
Recruiting
Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children
Urinary Incontinence, Daytime Wetting
RecruitingObservational study
The Voided Urinary, Perineal, and Faecal Microbiota Among Children and Adolescents - the PpUF-study.
Urinary Incontinence, Daytime Wetting
Recruiting
Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children
Daytime Urinary Incontinence, Urinary Frequency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anneli Saarikoski principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voiding school in people with Daytime Wetting and Enuresis, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in wetting episodes (time frame: at baseline, after intervention (3 months), follow-up 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.