A MOBILE APPLICATION DEVELOPED FOR CHILDREN WITH URINARY INCONTINENCE

• Sponsor: Eskisehir Osmangazi University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05815940
• Collaborator: The Scientific and Technological Research Council of Turkey (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Behavioral: Mobile Application	N/A

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

1. Content Creation For Goals

2. Interface design development on MS Word and Photoshop

3. Evaluation by specialists for content and design

4. Converting to mobile application on Android and IOS platforms

5. A pilot study with 10 children to evaluate the usability and suitability of the application

6. Get feedback on the mobile app

7. Based on this feedback, the mobile application was revised.

8. Its final version was created

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A MOBILE APPLICATION DEVELOPED FOR CHILDREN WITH URINARY INCONTINENCE: PILOT STUDY
• Actual Study Start Date: Aug 15, 2020
• Actual Primary Completion Date: Feb 15, 2021
• Actual Study Completion Date: Aug 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pilot study 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; a mobile application was developed that can be used by children with urinary incontinence and their parents.

Outcome Measures

Primary Outcome Measures

1. mobile application development [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.

Secondary Outcome Measures

1. pilot tested [one month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eskisehir Osmangazi University	Eskisehir		Turkey

Sponsors and Collaborators

• Eskisehir Osmangazi University
• The Scientific and Technological Research Council of Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merve Çakırlı, Research Assisstant, Eskisehir Osmangazi University
• ClinicalTrials.gov Identifier: NCT05815940
• Other Study ID Numbers: EskisehirOU-cakirli-2
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Merve Çakırlı, Research Assisstant, Eskisehir Osmangazi University: Mobile Application; Child; Quality of Life
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis

Study Results

No Results Posted as of Apr 18, 2023