Urinary IncontinenceNCT05815940
A MOBILE APPLICATION DEVELOPED FOR CHILDREN WITH URINARY INCONTINENCE
A study testing Mobile Application in people with Urinary Incontinence, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The study included 2 stages: In the first, a mobile application with content including urotherapy training and patient follow-up was developed. In the second, a pilot study with the developed mobile application was carried out with 10 children. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2020to 15 Aug 2021
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child has day and/or night urinary incontinence,
- The child is between 7-12 years of age,
- Family members and children can use mobile applications,
- Family members have a smartphone,
- The child and family members volunteers to participate in the study.
Who cannot join
- The child has a mental or neurological disability,
- The child has a developmental delay,
- The child has previously received treatment for urinary incontinence,
- The child has a communication problem,
- The child has a history of surgery related to the urinary tract,
- The child has a psychiatric diagnosis,
Show all 9Show fewer
- The child has a urinary tract infection,
- The child has a radiological pathology on ultrasound,
- The child has a diagnosis of neurogenic bladder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A MOBILE APPLICATION DEVELOPED FOR CHILDREN WITH URINARY INCONTINENCE: PILOT STUDY
The study included 2 stages: In the first, a mobile application with content including urotherapy training and patient follow-up was developed. In the second, a pilot study with the developed mobile application was carried out with 10 children.
Read the detailed description
The study include two stages. In the first, a mobile application was developed that can be used by children with urinary incontinence and their parents. The mobile application includes the training on urinary incontinence and urotherapy in children as well as all the test results of the child and ensures the follow-up of the children's compliance with the treatment. The developed mobile application is operatable on smartphones and tablets with Android and IOS operating systems.
This was followed by the second phase, during which the mobile application developed was pilot tested with 10 children. Based on the feedback received from the users, the mobile application was finalized.
Mobile application development process
- Content Creation For Goals
- Interface design development on MS Word and Photoshop
- Evaluation by specialists for content and design
- Converting to mobile application on Android and IOS platforms
- A pilot study with 10 children to evaluate the usability and suitability of the application
- Get feedback on the mobile app
- Based on this feedback, the mobile application was revised.
- Its final version was created
- Conditions
- Urinary Incontinence
- Being tested
- Mobile Application
- Keywords
- Mobile Application, Child, Quality of Life
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationBehavioural
a mobile application was developed that can be used by children with urinary incontinence and their parents.
| Study group | Role | What they receive |
|---|---|---|
| pilot study | Experimental | This was followed by the second phase, during which the mobile application developed was pilot tested with 10 children. Based on the feedback received from the users, the mobile application was finalized. Receives: Behavioral: Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
mobile application development
a mobile application was developed that can be used by children with urinary incontinence and their parents. The mobile application includes the training on urinary incontinence and urotherapy in children as well as all the test results of the child and ensures the follow-up of the children's compliance with the treatment. The developed mobile application is operatable on smartphones and tablets with Android and IOS operating systems.
Measured: six months
Secondary outcomes (1)
pilot tested
This was followed by the second phase, during which the mobile application developed was pilot tested with 10 children. Based on the feedback received from the users, the mobile application was finalized.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Aug 2020
- Primary completion15 Feb 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Merve Çakırlı, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815940
- Sponsor's protocol ID
- EskisehirOU-cakirli-2
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acikgoz A, Cakirli M, Tokar B, Celik O. SunCloud: A mobile application for children with urinary incontinence. J Eval Clin Pract. 2025 Feb;31(1):e14122. doi: 10.1111/jep.14122. Epub 2024 Aug 7.
PubMed 39113266
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MOBILE APPLICATION DEVELOPED FOR CHILDREN WITH URINARY INCONTINENCE: PILOT STUDY
- ClinicalTrials.gov ID
- NCT05815940
- Acronym / sponsor ID
- EskisehirOU-cakirli-2
- Conditions
- Urinary Incontinence
- Keywords
- Mobile Application, Child, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 18 Apr 2023 (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 study included 2 stages: In the first, a mobile application with content including urotherapy training and patient follow-up was developed. In the second, a pilot study with the developed mobile application was carried out with 10 children.
Detailed description
The study include two stages. In the first, a mobile application was developed that can be used by children with urinary incontinence and their parents. The mobile application includes the training on urinary incontinence and urotherapy in children as well as all the test results of the child and ensures the follow-up of the children's compliance with the treatment. The developed mobile application is operatable on smartphones and tablets with Android and IOS operating systems.
This was followed by the second phase, during which the mobile application developed was pilot tested with 10 children. Based on the feedback received from the users, the mobile application was finalized.
Mobile application development process
- Content Creation For Goals
- Interface design development on MS Word and Photoshop
- Evaluation by specialists for content and design
- Converting to mobile application on Android and IOS platforms
- A pilot study with 10 children to evaluate the usability and suitability of the application
- Get feedback on the mobile app
- Based on this feedback, the mobile application was revised.
- Its final version was created
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pilot study | Experimental | Behavioral: Mobile ApplicationThis was followed by the second phase, during which the mobile application developed was pilot tested with 10 children. Based on the feedback received from the users, the mobile application was finalized. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child has day and/or night urinary incontinence,
- The child is between 7-12 years of age,
- Family members and children can use mobile applications,
- Family members have a smartphone,
- The child and family members volunteers to participate in the study.
Key exclusion criteria (9 listed)
- The child has a mental or neurological disability,
- The child has a developmental delay,
- The child has previously received treatment for urinary incontinence,
- The child has a communication problem,
- The child has a history of surgery related to the urinary tract,
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 |
|---|---|---|
| Mobile Applicationa mobile application was developed that can be used by children with urinary incontinence and their parents. | Behavioural | pilot study |
Primary outcome
mobile application development
Time frame: six months
a mobile application was developed that can be used by children with urinary incontinence and their parents. The mobile application includes the training on urinary incontinence and urotherapy in children as well as all the test results of the child and ensures the follow-up of the children's compliance with the treatment. The developed mobile application is operatable on smartphones and tablets with Android and IOS operating systems.
1 secondary outcome
pilot tested
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39113266Acikgoz A, Cakirli M, Tokar B, Celik O. SunCloud: A mobile application for children with urinary incontinence. J Eval Clin Pract. 2025 Feb;31(1):e14122. doi: 10.1111/jep.14122. Epub 2024 Aug 7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application in people with Urinary Incontinence, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 18 Apr 2023. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mobile application development (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05815940, which also lists 1 linked publication.
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 18 Apr 2023.