Clean Intermittent CatheterizationNCT07489261
Effect of Mobile Application- and AI Supported Video-Based Patient Education on Patient Outcomes in Teaching Clean Intermittent Catheterization
A study testing Mobile application and Artifial intellgience in people with Clean Intermittent Catheterization, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to determine the effects of a mobile application and an artificial intelligence-supported educational video, developed for patients who will perform clean intermittent catheterization (CIC), on patients' adherence, levels of difficulty, self-confidence, infection parameters (urinalysis, urine culture… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clean Intermittent Catheterization
- What is being tested?
- Mobile application and Artifial intellgience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who require intermittent catheterization (TAK),
- Aged 18 years or older,
- Willing to participate in the study,
- Able to understand Turkish,
- Literate,
- Without visual or hearing impairments,
- Owning a smartphone, tablet, or computer,
- Without difficulties using technology.
Who cannot join
- Patients who do not require intermittent catheterization (TAK),
- Under 18 years of age,
- Not willing to participate in the study,
- Do not understand Turkish,
- Illiterate,
- With visual or hearing impairments,
- Do not own a smartphone, tablet, or computer,
- Having difficulties using technology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ELİFE KETTAŞ DÖLEK, Principal İnvestigator contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mersin Unıversıty
Mersin
GAMZE BOZKUL, gamze.bozkul@gmail.com
Elife Kettaş dölek, elifeket@yahoo.com
About this study
Official title: Effect of Mobile Application- and Artificial Intelligence-Supported Video-Based Patient Education on Patient Outcomes in Teaching Clean Intermittent Catheterization
The study aimed to determine the effects of a mobile application and an artificial intelligence-supported educational video, developed for patients who will perform clean intermittent catheterization (CIC), on patients' adherence, levels of difficulty, self-confidence, infection parameters (urinalysis, urine culture, infection incidence), and recurrent hospital admissions.The number of CIC patients who applied to the Urology Outpatient Clinic of Mersin University within the last year was 110. Since no similar study was found, the sample size was calculated using an a priori power analysis with G*Power 3.1.9.7 software. . As a result of the power analysis, the total sample size was calculated as 90, with 30 participants in each group. Considering a possible data loss (dropout) rate of approximately 10%, it was planned to include 33 participants in each group (a total of 99 participants) at the beginning of the study.Data will be collected using the "Descriptive Information Form," "Intermittent Catheterization Adherence Scale," "Self-Confidence Scale in Clean Intermittent Self-Catheterization," "Intermittent Catheterization Difficulty Questionnaire," and the "Patient Follow-up Form."Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) and an artificial intelligence-supported educational video (intervention group 2). Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.
Read the detailed description
The study was designed as a prospective, three-arm (1:1:1), randomized controlled clinical trial. The study will be conducted at the Urology Outpatient Clinic of Mersin University Faculty of Medicine Hospital. The Urology Outpatient Clinic includes adult and pediatric outpatient units, an intervention room, an ultrasound room, an andrology laboratory, a lithotripsy unit, and a urodynamics unit. The Department of Urology consists of seven faculty members and 11 research assistants. In the urology outpatient clinic, there is one nurse, two technicians, two secretaries, and one cleaning staff member. Outpatient services are provided between 08:00 and 17:00, and clean intermittent catheterization (CIC) training is also delivered to patients during these hours. The nurse provides training to patients who will perform CIC using a brochure. After the training, patients routinely return to the outpatient clinic for follow-up visits on the 15th day and at the 3rd month. study aimed to determine the effects of a mobile application and an artificial intelligence-supported educational video, developed for patients who will perform clean intermittent catheterization (CIC), on patients' adherence, levels of difficulty, self-confidence, infection parameters (urinalysis, urine culture, infection incidence), and recurrent hospital admissions.The number of CIC patients who applied to the Urology Outpatient Clinic of Mersin University within the last year was 110. Since no similar study was found, the sample size was calculated using an a priori power analysis with G*Power 3.1.9.7 software. For the one-way analysis of variance (ANOVA), the parameters used were α error probability = 0.05, power (1-β error probability) = 0.80, number of groups = 3, and effect size f = 0.40 (large effect size). As a result of the power analysis, the total sample size was calculated as 90, with 30 participants in each group. Considering a possible data loss (dropout) rate of approximately 10% , it was planned to include 33 participants in each group (a total of 99 participants) at the beginning of the study.Data will be collected using the "Descriptive Information Form," "Intermittent Catheterization Adherence Scale," "Self-Confidence Scale in Clean Intermittent Self-Catheterization," "Intermittent Catheterization Difficulty Questionnaire," and the "Patient Follow-up Form."Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) and an artificial intelligence-supported educational video (intervention group 2). Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.
- Conditions
- Clean Intermittent Catheterization
- Being tested
- Mobile application, Artifial intellgience
- Keywords
- Mobile application, Artificial intelligience, Patient Outcome, Patient Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationOther
Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1)
Artifial intellgienceOther
Patients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Mobile application group | Experimental | Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) Receives: Other: Mobile application |
| Experimental group: Artificial intelligent video group | Experimental | Patients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2). Receives: Other: Artifial intellgience |
| Control group | No intervention | Patients in the control group will be trained using the routine brochure provided in the outpatient clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
The Intermittent Catheterization Adherence Scale was developed by Amandine Guinet-Lacoste and colleagues in 2018, and its Turkish adaptation and reliability study were conducted by Duman in 2021. The first seven items of the scale (except the fifth item) are scored as "Yes = 1" and "No = 0," while the fifth item is scored in reverse: "Yes = 0" and "No = 1." The eighth item uses a 5-point Likert scale, scored as "Never = 0," "Sometimes = 0.25," "Often = 0.50," "Most of the time = 0.75," and "Always = 1." The total score of the scale is calculated out of 8, with the resulting scores reflecting patients' adherence to catheterization. Accordingly, a score of 0 indicates "high adherence," 1-2 points indicate "moderate adherence," and 3-8 points indicate "low adherence." The Cronbach's alpha coefficient, indicating internal consistency of the scale, is 0.73.
Measured: 6 months
Self-Confidence
This scale was developed by Biaziolo and colleagues in 2017. The Turkish adaptation, validity, and reliability study was conducted by Çulha and Acaroğlu in 2020. The scale, which has a five-point Likert-type structure, consists of short statements that assess the steps of catheterization and the individual's self-confidence in performing this procedure. The response options are as follows: 1 = Not confident, 2 = Slightly confident, 3 = Confident, 4 = Very confident, 5 = Completely confident. The scale consists of a total of 16 items. The total score is calculated by summing the numerical values of the responses to all items, and the total score ranges from 0 to 64. Higher scores indicate a higher level of self-confidence in performing catheterization. The internal consistency of the scale was found to be quite high, with a total Cronbach's alpha coefficient of 0.89.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Apr 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Clean Intermittent CatheterizationStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as a prospective, three-arm (1:1:1), randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elife Kettas Dolek, Mersin University
- Investigators
- GAMZE BOZKUL, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489261
- Sponsor's protocol ID
- MU-002
- Status last verified
- Jun 2026
- First submitted
- 19 Mar 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bobian M, Kandinov A, El-Kashlan N, Svider PF, Folbe AJ, Mayerhoff R, Eloy JA, Raza SN. Mobile applications and patient education: Are currently available GERD mobile apps sufficient? Laryngoscope. 2017 Aug;127(8):1775-1779. doi: 10.1002/lary.26341. Epub 2016 Oct 18.
PubMed 27753101Cerantola Y, Valerio M, Persson B, Jichlinski P, Ljungqvist O, Hubner M, Kassouf W, Muller S, Baldini G, Carli F, Naesheimh T, Ytrebo L, Revhaug A, Lassen K, Knutsen T, Aarsether E, Wiklund P, Patel HR. Guidelines for perioperative care after radical cystectomy for bladder cancer: Enhanced Recovery After Surgery (ERAS((R))) society recommendations. Clin Nutr. 2013 Dec;32(6):879-87. doi: 10.1016/j.clnu.2013.09.014. Epub 2013 Oct 17.
PubMed 24189391Bhuyan SS, Sateesh V, Mukul N, Galvankar A, Mahmood A, Nauman M, Rai A, Bordoloi K, Basu U, Samuel J. Generative Artificial Intelligence Use in Healthcare: Opportunities for Clinical Excellence and Administrative Efficiency. J Med Syst. 2025 Jan 16;49(1):10. doi: 10.1007/s10916-024-02136-1.
PubMed 39820845Hernandez-Rodriguez JC, Garcia-Munoz C, Ortiz-Alvarez J, Saigi-Rubio F, Conejo-Mir J, Pereyra-Rodriguez JJ. Dropout Rate in Digital Health Interventions for the Prevention of Skin Cancer: Systematic Review, Meta-analysis, and Metaregression. J Med Internet Res. 2022 Dec 9;24(12):e42397. doi: 10.2196/42397.
PubMed 36485027Alasker A, Alsalamah S, Alshathri N, Almansour N, Alsalamah F, Alghafees M, AlKhamees M, Alsaikhan B. Performance of large language models (LLMs) in providing prostate cancer information. BMC Urol. 2024 Aug 23;24(1):177. doi: 10.1186/s12894-024-01570-0.
PubMed 39180045
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile Application- and Artificial Intelligence-Supported Video-Based Patient Education on Patient Outcomes in Teaching Clean Intermittent Catheterization
- ClinicalTrials.gov ID
- NCT07489261
- Acronym / sponsor ID
- MU-002
- Conditions
- Clean Intermittent Catheterization
- Keywords
- Mobile application, Artificial intelligience, Patient Outcome, Patient Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 Mar 2026 (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 aimed to determine the effects of a mobile application and an artificial intelligence-supported educational video, developed for patients who will perform clean intermittent catheterization (CIC), on patients' adherence, levels of difficulty, self-confidence, infection parameters (urinalysis, urine culture, infection incidence), and recurrent hospital admissions.The number of CIC patients who applied to the Urology Outpatient Clinic of Mersin University within the last year was 110. Since no similar study was found, the sample size was calculated using an a priori power analysis with G*Power 3.1.9.7 software. . As a result of the power analysis, the total sample size was calculated as 90, with 30 participants in each group. Considering a possible data loss (dropout) rate of approximately 10%, it was planned to include 33 participants in each group (a total of 99 participants) at the beginning of the study.Data will be collected using the "Descriptive Information Form," "Intermittent Catheterization Adherence Scale," "Self-Confidence Scale in Clean Intermittent Self-Catheterization," "Intermittent Catheterization Difficulty Questionnaire," and the "Patient Follow-up Form."Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) and an artificial intelligence-supported educational video (intervention group 2). Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.
Detailed description
The study was designed as a prospective, three-arm (1:1:1), randomized controlled clinical trial. The study will be conducted at the Urology Outpatient Clinic of Mersin University Faculty of Medicine Hospital. The Urology Outpatient Clinic includes adult and pediatric outpatient units, an intervention room, an ultrasound room, an andrology laboratory, a lithotripsy unit, and a urodynamics unit. The Department of Urology consists of seven faculty members and 11 research assistants. In the urology outpatient clinic, there is one nurse, two technicians, two secretaries, and one cleaning staff member. Outpatient services are provided between 08:00 and 17:00, and clean intermittent catheterization (CIC) training is also delivered to patients during these hours. The nurse provides training to patients who will perform CIC using a brochure. After the training, patients routinely return to the outpatient clinic for follow-up visits on the 15th day and at the 3rd month. study aimed to determine the effects of a mobile application and an artificial intelligence-supported educational video, developed for patients who will perform clean intermittent catheterization (CIC), on patients' adherence, levels of difficulty, self-confidence, infection parameters (urinalysis, urine culture, infection incidence), and recurrent hospital admissions.The number of CIC patients who applied to the Urology Outpatient Clinic of Mersin University within the last year was 110. Since no similar study was found, the sample size was calculated using an a priori power analysis with G*Power 3.1.9.7 software. For the one-way analysis of variance (ANOVA), the parameters used were α error probability = 0.05, power (1-β error probability) = 0.80, number of groups = 3, and effect size f = 0.40 (large effect size). As a result of the power analysis, the total sample size was calculated as 90, with 30 participants in each group. Considering a possible data loss (dropout) rate of approximately 10% , it was planned to include 33 participants in each group (a total of 99 participants) at the beginning of the study.Data will be collected using the "Descriptive Information Form," "Intermittent Catheterization Adherence Scale," "Self-Confidence Scale in Clean Intermittent Self-Catheterization," "Intermittent Catheterization Difficulty Questionnaire," and the "Patient Follow-up Form."Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) and an artificial intelligence-supported educational video (intervention group 2). Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study was designed as a prospective, three-arm (1:1:1), randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Mobile application group | Experimental | Other: Mobile applicationPatients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) |
| Experimental group: Artificial intelligent video group | Experimental | Other: Artifial intellgiencePatients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2). |
| Control group | No intervention | –Patients in the control group will be trained using the routine brochure provided in the outpatient clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who require intermittent catheterization (TAK),
- Aged 18 years or older,
- Willing to participate in the study,
- Able to understand Turkish,
- Literate,
Key exclusion criteria (8 listed)
- Patients who do not require intermittent catheterization (TAK),
- Under 18 years of age,
- Not willing to participate in the study,
- Do not understand Turkish,
- Illiterate,
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 applicationPatients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) | Other | Experimental Group: Mobile application group |
| Artifial intellgiencePatients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2) | Other | Experimental group: Artificial intelligent video group |
Primary outcome
Adherence
Time frame: 6 months
The Intermittent Catheterization Adherence Scale was developed by Amandine Guinet-Lacoste and colleagues in 2018, and its Turkish adaptation and reliability study were conducted by Duman in 2021. The first seven items of the scale (except the fifth item) are scored as "Yes = 1" and "No = 0," while the fifth item is scored in reverse: "Yes = 0" and "No = 1." The eighth item uses a 5-point Likert scale, scored as "Never = 0," "Sometimes = 0.25," "Often = 0.50," "Most of the time = 0.75," and "Always = 1." The total score of the scale is calculated out of 8, with the resulting scores reflecting patients' adherence to catheterization. Accordingly, a score of 0 indicates "high adherence," 1-2 points indicate "moderate adherence," and 3-8 points indicate "low adherence." The Cronbach's alpha coefficient, indicating internal consistency of the scale, is 0.73.
Self-Confidence
Time frame: 6 months
This scale was developed by Biaziolo and colleagues in 2017. The Turkish adaptation, validity, and reliability study was conducted by Çulha and Acaroğlu in 2020. The scale, which has a five-point Likert-type structure, consists of short statements that assess the steps of catheterization and the individual's self-confidence in performing this procedure. The response options are as follows: 1 = Not confident, 2 = Slightly confident, 3 = Confident, 4 = Very confident, 5 = Completely confident. The scale consists of a total of 16 items. The total score is calculated by summing the numerical values of the responses to all items, and the total score ranges from 0 to 64. Higher scores indicate a higher level of self-confidence in performing catheterization. The internal consistency of the scale was found to be quite high, with a total Cronbach's alpha coefficient of 0.89.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 27753101Bobian M, Kandinov A, El-Kashlan N, Svider PF, Folbe AJ, Mayerhoff R, Eloy JA, Raza SN. Mobile applications and patient education: Are currently available GERD mobile apps sufficient? Laryngoscope. 2017 Aug;127(8):1775-1779. doi: 10.1002/lary.26341. Epub 2016 Oct 18.
- Results publication: PubMed 24189391Cerantola Y, Valerio M, Persson B, Jichlinski P, Ljungqvist O, Hubner M, Kassouf W, Muller S, Baldini G, Carli F, Naesheimh T, Ytrebo L, Revhaug A, Lassen K, Knutsen T, Aarsether E, Wiklund P, Patel HR. Guidelines for perioperative care after radical cystectomy for bladder cancer: Enhanced Recovery After Surgery (ERAS((R))) society recommendations. Clin Nutr. 2013 Dec;32(6):879-87. doi: 10.1016/j.clnu.2013.09.014. Epub 2013 Oct 17.
- Results publication: PubMed 39820845Bhuyan SS, Sateesh V, Mukul N, Galvankar A, Mahmood A, Nauman M, Rai A, Bordoloi K, Basu U, Samuel J. Generative Artificial Intelligence Use in Healthcare: Opportunities for Clinical Excellence and Administrative Efficiency. J Med Syst. 2025 Jan 16;49(1):10. doi: 10.1007/s10916-024-02136-1.
- Results publication: PubMed 36485027Hernandez-Rodriguez JC, Garcia-Munoz C, Ortiz-Alvarez J, Saigi-Rubio F, Conejo-Mir J, Pereyra-Rodriguez JJ. Dropout Rate in Digital Health Interventions for the Prevention of Skin Cancer: Systematic Review, Meta-analysis, and Metaregression. J Med Internet Res. 2022 Dec 9;24(12):e42397. doi: 10.2196/42397.
- Results publication: PubMed 39180045Alasker A, Alsalamah S, Alshathri N, Almansour N, Alsalamah F, Alghafees M, AlKhamees M, Alsaikhan B. Performance of large language models (LLMs) in providing prostate cancer information. BMC Urol. 2024 Aug 23;24(1):177. doi: 10.1186/s12894-024-01570-0.
- 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.
ELİFE KETTAŞ DÖLEK, Principal İnvestigator contact
GAMZE BOZKUL principal investigator
Tarsus University
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 and Artifial intellgience in people with Clean Intermittent Catheterization, run by Mersin 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ELİFE KETTAŞ DÖLEK, Prinicipal İnvestigator (03242410000, elifeket@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 6 months). 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 NCT07489261, which also lists 5 linked publications.
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 24 Jun 2026.