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Neurogenic BladderNCT06429631

The Effects of CIC Training With a Mobile Application on Quality of Life and Compliance in Spinal Cord Injury Patients: a Single Blind Randomized Controlled Study

A study testing mobile application on telephone in people with Neurogenic Bladder and Spinal Cord Injury, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Neurogenic bladder is a condition that occurs due to nerve damage or congenital problems and causes urination disorders. Nowadays, in individuals diagnosed with neurogenic bladder, Clean Intermittent Catheterization is often used to evacuate the urine accumulated in the bladder. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
mobile application on telephone
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Aug 2023to 15 Nov 2024
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

The study inclusion criteria were (1) 18-65 years of age, (2) receiving CIC training for the first time, (3) having sufficient manual dexterity, (4) using a single-use hydrophilic catheter, (5) having an IOS/Android phone and internet access, (6) having no vision problems, (7) having a Body Mass Index (BMI) <30, (8) speaking Turkish.

Participants were excluded if (1) they wanted to withdraw from the study, (2) they did not complete the data collection forms, (3) the doctor decided they should stop CIC, (4) they did not use the mobile application in the intervention group, and (5) they had received CIC training more than one month ago.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

    Ankara, Çankaya, 0000000

  • Ankara Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

    Ankara, Çankaya, 680000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of CIC Training With a Mobile Application on Quality of Life and Compliance in Spinal Cord Injury Patients: a Single Blind Randomized Controlled Study (CIC: Clean Intermittent Catheterization)

Neurogenic bladder is a condition that occurs due to nerve damage or congenital problems and causes urination disorders. Nowadays, in individuals diagnosed with neurogenic bladder, Clean Intermittent Catheterization is often used to evacuate the urine accumulated in the bladder. Clean Intermittent Catheterization(CIC) is a simple, safe and effective method in which the catheter is placed through the meatus. In this application, the catheter is removed without waiting after urine drainage is achieved. This process is usually performed on its own. Since IC(Intermittent Catheterization) is a procedure performed on the bladder, it may cause some complications. IC application must be performed successfully to prevent or reduce complications. The success of the technique largely depends on patient education and follow-up. Sometimes patients may not be able to come to the hospital for follow-up and feedback after IC training.

Innovations are needed to ensure the continuation of distance education so that the education of patients who cannot come to the hospital is not incomplete. The literature includes brochures, videos, websites and some mobile applications for IC training. However, no application has been found that monitors patients' urine amounts.

This research was planned to examine the effect of clean intermittent catheterization training given via mobile application to individuals with spinal cord injury on their quality of life and compliance.

Read the detailed description

scales:

  1. Information form: Authors will ask to patients age, weight, height, gender, marital status, education level, diagnosis, time of injury, cause of injury, independence level, working or not working, presence of spasticity
  2. WHOQOL-BREF(World Health Organization Quality of Life Scale):The WHO Quality of Life Assessment (WHOQOL) is a generic quality of life instrument that was designed to be applicable to people living under different circumstances, conditions, and cultures. The short version known as WHOQOL-BREF with 27 itemsin Turkish version. It is based on a Likert-type scale and is scored from 1 to 5, with higher scores indicating a better quality of life.
  3. Intermittent Self-Catheterization Questionnaire (ISC-Q): This is a 24-item self-administered questionnaire. Each item is scored on a 5-point Likert-type scale ranging from 0 (strongly disagree) to 4 (strongly agree), and after the conversion of the 14 reverse-coded items to give a common range of 0-100, the scores are calculated by multiplying the mean value of all items within each domain by 25. The total ISC-Q score is then calculated from the simple average from across the four domains (0-100), with higher scores indicating a higher quality of life.
  4. Intermittent Catheterization Adherence Scale (ICAS): ICAS (IntermittentCatheterization Adherence Scale) is used to assess long-term patient adherence to prescribed ISC treatment. Binary answers were used for the first seven questions:yes = 1, no = 0, whereas the response options for the eighth question were graded on a 5-point Likert-type scale: 0 indicating "never," 0.25 "sometimes," 0.5 "often,"0.75 "regularly," and 1 "always," leading to a maximum possible score of 8. A patient's score is empirically classified into three intervals: strong adherence = 0; average adherence = 1-2; low adherence = 3-8.
  5. Mobile Application Usability Scale (MAUS): The scale measures mobile application usability which is formed with 10 constructs/factors which includes four items each (40 items at total). The scale measures using a 7-point Likert-type scale (1=strongly disagree…7=strongly agree)
Being tested
mobile application on telephone
Keywords
neurogenic bladder, education, mobil application, compliance, quality of life
Medical subject headings
Urinary Bladder, Neurogenic, Spinal Cord Injuries, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mobile application on telephoneDevice

    when patient discharge from the hospital, mobile application downloaded their telephone. then researcher give feedback about patients CIC outputs.

    also mobile application include 2 animations, videos, "frequently asked questions" and "ask the expert" section.

Study groups in NCT06429631
Study groupRoleWhat they receive
control group(routine CIC education)No interventionThis group has routine CIC education. They fill the scales before discharge and 12. week after discharge.
experimental group(routine CIC education+mobile application on telephone)ExperimentalThis group has routine CIC education. Also mobile application uploaded their telephone before discharge. They fill the scales before discharge and 12. week after discharge.
Receives: Device: mobile application on telephone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. WHOQOL-BREF(World Health Organization Quality of Life questionnaire),

    This study want to evaluate quality of life with 2 scales. WHOQOL-BREF(World Health Organization Quality of Life Scale):The WHO Quality of Life Assessment (WHOQOL) is a generic quality of life instrument that was designed to be applicable to people living under different circumstances, conditions, and cultures. The short version known as WHOQOL-BREF with 26 items. Turkish version is 27 items. It is based on a Likert-type scale and is scored from 1 to 5, with higher scores indicating a better quality of life.

    Measured: Patients fill the scale "before discharge" and 12 weeks after discharge.

  2. 2. Intermittent Self-Catheterization Questionnaire (ISC-Q)

    This is a 24-item self-administered questionnaire. Each item is scored on a 5-point Likert-type scale ranging from 0 (strongly disagree) to 4 (strongly agree), and after the conversion of the 14 reverse-coded items to give a common range of 0-100, the scores are calculated by multiplying the mean value of all items within each domain by 25. The total ISC-Q score is then calculated from the simple average from across the four domains (0-100), with higher scores indicating a higher quality of life.

    Measured: Patients fill the scale "before discharge" and 12 weeks after discharge.

Secondary outcomes (1)

  1. Intermittent Catheterization Adherence Scale (ICAS)

    This study want to evaluate compliance with one scale. ICAS (IntermittentCatheterization Adherence Scale) is used to assess long-term patient adherence to prescribed ISC treatment. Binary answers were used for the first seven questions:yes = 1, no = 0, whereas the response options for the eighth question were graded on a 5-point Likert-type scale: 0 indicating "never," 0.25 "sometimes," 0.5 "often,"0.75 "regularly," and 1 "always," leading to a maximum possible score of 8. A patient's score is empirically classified in to three intervals: strong adherence = 0; average adherence = 1-2; low adherence = 3-8.

    Measured: Patients fill the scale "before discharge" and 12 weeks after discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2024
  2. Study start1 Aug 2023
  3. Primary completion15 Aug 2024
  4. Study completion15 Nov 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
parallel group single-blind randomized control trial
Masking
Single blind
Who is masked
Participant
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06429631
Sponsor's protocol ID
77082166-302.08.01-424987
Status last verified
Mar 2025
First submitted
18 May 2024
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Since the study is still not finished, it was decided not to share it.

Questions about this trial

What is this clinical trial studying?

A study testing mobile application on telephone in people with Neurogenic Bladder and Spinal Cord Injury, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 2 sites 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?

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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

1. WHOQOL-BREF(World Health Organization Quality of Life questionnaire), (time frame: Patients fill the scale "before discharge" and 12 weeks after discharge.). The study lists 2 primary outcomes in all. 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 NCT06429631.

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 6 Mar 2025.

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