NCT05815940

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

April 3, 2023

Last Update Submit

April 14, 2023

Conditions

Keywords

Mobile ApplicationChildQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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.

    six months

Secondary Outcomes (1)

  • pilot tested

    one month

Study Arms (1)

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.

Behavioral: Mobile Application

Interventions

a mobile application was developed that can be used by children with urinary incontinence and their parents.

pilot study

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • The child has a urinary tract infection,
  • The child has a radiological pathology on ultrasound,
  • The child has a diagnosis of neurogenic bladder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 18, 2023

Study Start

August 15, 2020

Primary Completion

February 15, 2021

Study Completion

August 15, 2021

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations