Benign Prostate EnlargementNCT05765331
The Impact of Chatbot-aid on Promoting Self-management of Men's Health in the Post COVID-19 Era
A study testing Chatbot in people with Benign Prostate Enlargement and Lower Urinary Tract Symptoms, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
The AI chatbot as an artificial intelligence technology provides disease information and health care through digital assistance. However, the effectiveness of chatbot in promoting men's health in the field of urology needs further research to evaluate its actual results. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostate Enlargement, Lower Urinary Tract Symptoms, Erectile Dysfunction
- What is being tested?
- Chatbot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jan 2023to 31 Dec 2023
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 45 years to 80 years old
- Prostate enlargement with lower urinary tract symptoms
- Need a mobile phone and willing to download the line chatbot
Who cannot join
- Psychosis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cheng Hsin General Hospital
Taipei, 112
Kuang-Kuo Chen, MD, PhD, +886-2-2826-4400 ext. 8007, kkchen@vghtpe.gov.tw
Pei-Pei Chiu, RN, MS, +886-9-87677-711, kyoto.sakura0106@gmail.com
About this study
Official title: Evaluating the Effectiveness of Chatbot-Based Intervention on Enhancing Self-management and Decision Self-efficacy Among Men Having Lower Urinary Tract Symptoms With or Without Erectile Dysfunction in the Post COVID-19 Era
The AI chatbot as an artificial intelligence technology provides disease information and health care through digital assistance. However, the effectiveness of chatbot in promoting men's health in the field of urology needs further research to evaluate its actual results. The purpose of this study is to explore the impact of AI chatbot-aid intervention on enhancing self-management, and decision self-efficacy among men with lower urinary tract symptoms (LUTS) due to an enlarged prostate, and with or without erectile dysfunction (ED) in the post COVID-19 era.
Read the detailed description
- Background and objectives : After the age of 50 years, men's health may be impacted by various disorders such as lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Due to a lack of understanding and awareness, patients often fail to recognize early signs and are not compliant with medical advice. As they are hesitant to discuss these issues related to urination and erectile functions, they avoid seeking medical help, especially due to the restrictions and concerns brought by the COVID-19 pandemic. Consequently, worsening symptoms can adversely affect their quality of life and dignity. Studies have found that providing men with self-management health programs results in better symptom management and medical decisions. Therefore, work is underway to develop artificial intelligence (AI) platforms to allow men to manage their health before consulting a doctor. Chatbots are used for various medical decisions and healthcare management, and can now provide men with various healthcare information to help improve the effectiveness of self-care and medical treatments in the post COVID-19 period. The purpose of this study is to explore the impact of AI chatbot aid intervention on enhancing self-management, and decision self-efficacy among men with lower urinary tract symptoms (LUTS) due to an enlarged prostate, with or without erectile dysfunction (ED) in the post COVID-19 era.
- Materials and Methods:
2.1. Trial design and ethical approval
This was a 1:1 two groups randomized controlled trial (RCT) with pre- and post-test experimental design. This study was approved by the Institutional Review Board (IRB) of Cheng Hsin General Hospital in Taipei, Taiwan (approval number CHGH-IRB (988)111A-66-2) and participants were provided with informed consent. Both groups had similar demographics. One hundred male patients will be recruited from the Urology outpatient clinic, with 50 patients randomly assigned to the experimental group and 50 patients to the control group.
2.2 Participants
Patients diagnosed with health-related diseases by urologists were included in this study. The conditions were as follows:(1) male, (2) age between 45-80 years old, (3) prostate enlargement with lower urinary tract symptoms, (4) need a mobile phone and willing to download the line chatbot. The exclusion criterion was a history of psychosis.
2.3 Intervention
The study uses a chatbot in collaboration with the Taiwan Urological Association (TUA) and the Taiwan Continence Society (TCS), which is deployed on the line app for mobile devices. The chatbot uses an AI model integrated with the line developer platform to predict risks for men's health conditions such as urinary symptoms and erectile dysfunction. Patients can access the chatbot for free by scanning a QR code. It provides self-management advice on issues such as prostate enlargement, urinary symptoms, and erectile dysfunction. It also provides patient-centered decision-making aids that support and encourage patients, especially in improving urination and erectile dysfunction.
2.4 Research instruments
The patients in both groups were asked to complete a basic personal information form, as well as several questionnaires including the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), Men's Health knowledge score, Partners in Health (PIH), and Decision Self-Efficacy Scale (DSES) before and 2-4 weeks after receiving the intervention measures. Additional examination data, such as prostate-specific antigen (PSA), uroflowmetry, and prostate sonography, were collected from medical records. A satisfaction questionnaire was also administered to the patients.
2.5 Statistical methods
SPSS was used for statistical analysis, including McNemar's test and independent sample t-test were used to compare and analyze the difference in the knowledge score, self-management, and decision-making self-efficacy between the experimental group and control group before and after the intervention; paired t-test was used to compare individuals before and after receiving intervention measures; Pearson's correlation was used to analyze the relationship among LUTS, knowledge score, self-management, and decision self-efficacy; Finally, multiple regression analysis to analyze the impact of using the chatbot on satisfaction.
- Being tested
- Chatbot
- Keywords
- Lower urinary tract symptoms, Erectile dysfunction, Men's Health, Chatbot, Chronic disease self-management, Decision self-efficacy
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotDevice
The AI chatbot is a kind of artificial intelligence technology that can help increase knowledge and understanding of men's health issues. That interacts with subjects through literal text and provides educational resources, advice, and assistance related to lifestyle changes. The chatbot is a valuable aid to increase men's health by providing information about enlarged prostate with urination problems and erectile dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot-aid intervention | Experimental | Chatbot-aid intervention group Receives: Device: Chatbot |
| Control group | No intervention | Written routine nursing health education guidance intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Men's Health Knowledge Score
The 15 items of the Men's Health knowledge score are based on urination, prostate, and erectile dysfunction disorders. A total of 6 domains are to create men's health knowledge, which is used to evaluate the effectiveness of chatbot in promoting men's health knowledge.
Measured: Baseline and 2-4 weeks after intervention.
Partners in Health Scale
The Partners in Health (PIH) is a validated,12 items questionnaire scored on a self-rated 9-point Likert scale (range: 0-8; higher scores indicate better self-management).
Measured: Baseline and 2-4 weeks after intervention.
Decision Self-Efficacy Scale
The 11 items of the Decision Self-Efficacy Scale (DSES) used to assess the self-confidence of participants in their ability to make health decisions, ranged from 0 (not at all confident) to 4 (very confident).
Measured: Baseline and 2-4 weeks after intervention.
Secondary outcomes (1)
The evaluation of chatbot satisfaction.
There are 9 questions about the satisfaction level of using the chatbot, with a Likert scale of 1-5, where 1 is "extremely dissatisfied" and 5 is "extremely satisfied".
Measured: 2-4 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start2 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Benign Prostate EnlargementStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang-Kuo Chen, MD, PhD, Principal investigator, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765331
- Sponsor's protocol ID
- (988)111A-66-2
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Albarqouni L, Sanders S, Clark J, Tikkinen KAO, Glasziou P. Self-Management for Men With Lower Urinary Tract Symptoms: A Systematic Review and Meta-Analysis. Ann Fam Med. 2021 Mar-Apr;19(2):157-167. doi: 10.1370/afm.2609.
PubMed 33685877Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
PubMed 1279218Blanker MH, Brandenbarg P, Slijkhuis BGC, Steffens MG, van Balken MR, Jellema P. Development of an online personalized self-management intervention for men with uncomplicated LUTS. Neurourol Urodyn. 2019 Aug;38(6):1685-1691. doi: 10.1002/nau.24040. Epub 2019 May 20.
PubMed 31107577Bortnick E, Brown C, Simma-Chiang V, Kaplan SA. Modern best practice in the management of benign prostatic hyperplasia in the elderly. Ther Adv Urol. 2020 May 27;12:1756287220929486. doi: 10.1177/1756287220929486. eCollection 2020 Jan-Dec.
PubMed 32547642Calogero AE, Burgio G, Condorelli RA, Cannarella R, La Vignera S. Epidemiology and risk factors of lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction. Aging Male. 2019 Mar;22(1):12-19. doi: 10.1080/13685538.2018.1434772. Epub 2018 Feb 2.
PubMed 29392976Capogrosso P, Boeri L, Pozzi E, Ventimiglia E, Schifano N, Abbate C, Matloob R, Deho F, Montorsi F, Salonia A. Is It Compulsory to Investigate for Erectile Dysfunction in Patients Presenting for Low Urinary Tract Symptoms? Eur Urol Focus. 2021 Jan;7(1):172-177. doi: 10.1016/j.euf.2019.08.007. Epub 2019 Aug 30.
PubMed 31474582Chapple C, Castro-Diaz D, Chuang YC, Lee KS, Liao L, Liu SP, Wang J, Yoo TK, Chu R, Sumarsono B. Prevalence of Lower Urinary Tract Symptoms in China, Taiwan, and South Korea: Results from a Cross-Sectional, Population-Based Study. Adv Ther. 2017 Aug;34(8):1953-1965. doi: 10.1007/s12325-017-0577-9. Epub 2017 Jul 7.
PubMed 28687936Dumbraveanu I, Ceban E, Banov P. Lower urinary tract symptoms and erectile dysfunction in men from the Republic of Moldova. J Med Life. 2018 Apr-Jun;11(2):153-159.
PubMed 30140322Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
PubMed 8254833Ghose A, Roy S, Vasdev N, Olsburgh J, Dasgupta P. The Emerging Role of Artificial Intelligence in the Fight Against COVID-19. Eur Urol. 2020 Dec;78(6):775-776. doi: 10.1016/j.eururo.2020.09.031. Epub 2020 Sep 17.
PubMed 32994064Goldenthal SB, Portney D, Steppe E, Ghani K, Ellimoottil C. Assessing the feasibility of a chatbot after ureteroscopy. Mhealth. 2019 Mar 15;5:8. doi: 10.21037/mhealth.2019.03.01. eCollection 2019.
PubMed 31019961Griffith JW, Messersmith EE, Gillespie BW, Wiseman JB, Flynn KE, Kirkali Z, Kusek JW, Bavendam T, Cella D, Kreder KJ, Nero JJ, Corona ME, Bradley CS, Kenton KS, Helfand BT, Merion RM, Weinfurt KP; LURN Study Group. Reasons for Seeking Clinical Care for Lower Urinary Tract Symptoms: A Mixed Methods Study. J Urol. 2018 Feb;199(2):528-535. doi: 10.1016/j.juro.2017.07.067. Epub 2017 Jul 20.
PubMed 28734864Li JO, Liu H, Ting DSJ, Jeon S, Chan RVP, Kim JE, Sim DA, Thomas PBM, Lin H, Chen Y, Sakomoto T, Loewenstein A, Lam DSC, Pasquale LR, Wong TY, Lam LA, Ting DSW. Digital technology, tele-medicine and artificial intelligence in ophthalmology: A global perspective. Prog Retin Eye Res. 2021 May;82:100900. doi: 10.1016/j.preteyeres.2020.100900. Epub 2020 Sep 6.
PubMed 32898686Nadarzynski T, Miles O, Cowie A, Ridge D. Acceptability of artificial intelligence (AI)-led chatbot services in healthcare: A mixed-methods study. Digit Health. 2019 Aug 21;5:2055207619871808. doi: 10.1177/2055207619871808. eCollection 2019 Jan-Dec.
PubMed 31467682Nadarzynski T, Puentes V, Pawlak I, Mendes T, Montgomery I, Bayley J, Ridge D. Barriers and facilitators to engagement with artificial intelligence (AI)-based chatbots for sexual and reproductive health advice: a qualitative analysis. Sex Health. 2021 Nov;18(5):385-393. doi: 10.1071/SH21123.
PubMed 34782055
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Chatbot-Based Intervention on Enhancing Self-management and Decision Self-efficacy Among Men Having Lower Urinary Tract Symptoms With or Without Erectile Dysfunction in the Post COVID-19 Era
- ClinicalTrials.gov ID
- NCT05765331
- Acronym / sponsor ID
- (988)111A-66-2
- Keywords
- Lower urinary tract symptoms, Erectile dysfunction, Men's Health, Chatbot, Chronic disease self-management, Decision self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Mar 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 AI chatbot as an artificial intelligence technology provides disease information and health care through digital assistance. However, the effectiveness of chatbot in promoting men's health in the field of urology needs further research to evaluate its actual results. The purpose of this study is to explore the impact of AI chatbot-aid intervention on enhancing self-management, and decision self-efficacy among men with lower urinary tract symptoms (LUTS) due to an enlarged prostate, and with or without erectile dysfunction (ED) in the post COVID-19 era.
Detailed description
- Background and objectives : After the age of 50 years, men's health may be impacted by various disorders such as lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Due to a lack of understanding and awareness, patients often fail to recognize early signs and are not compliant with medical advice. As they are hesitant to discuss these issues related to urination and erectile functions, they avoid seeking medical help, especially due to the restrictions and concerns brought by the COVID-19 pandemic. Consequently, worsening symptoms can adversely affect their quality of life and dignity. Studies have found that providing men with self-management health programs results in better symptom management and medical decisions. Therefore, work is underway to develop artificial intelligence (AI) platforms to allow men to manage their health before consulting a doctor. Chatbots are used for various medical decisions and healthcare management, and can now provide men with various healthcare information to help improve the effectiveness of self-care and medical treatments in the post COVID-19 period. The purpose of this study is to explore the impact of AI chatbot aid intervention on enhancing self-management, and decision self-efficacy among men with lower urinary tract symptoms (LUTS) due to an enlarged prostate, with or without erectile dysfunction (ED) in the post COVID-19 era.
- Materials and Methods:
2.1. Trial design and ethical approval
This was a 1:1 two groups randomized controlled trial (RCT) with pre- and post-test experimental design. This study was approved by the Institutional Review Board (IRB) of Cheng Hsin General Hospital in Taipei, Taiwan (approval number CHGH-IRB (988)111A-66-2) and participants were provided with informed consent. Both groups had similar demographics. One hundred male patients will be recruited from the Urology outpatient clinic, with 50 patients randomly assigned to the experimental group and 50 patients to the control group.
2.2 Participants
Patients diagnosed with health-related diseases by urologists were included in this study. The conditions were as follows:(1) male, (2) age between 45-80 years old, (3) prostate enlargement with lower urinary tract symptoms, (4) need a mobile phone and willing to download the line chatbot. The exclusion criterion was a history of psychosis.
2.3 Intervention
The study uses a chatbot in collaboration with the Taiwan Urological Association (TUA) and the Taiwan Continence Society (TCS), which is deployed on the line app for mobile devices. The chatbot uses an AI model integrated with the line developer platform to predict risks for men's health conditions such as urinary symptoms and erectile dysfunction. Patients can access the chatbot for free by scanning a QR code. It provides self-management advice on issues such as prostate enlargement, urinary symptoms, and erectile dysfunction. It also provides patient-centered decision-making aids that support and encourage patients, especially in improving urination and erectile dysfunction.
2.4 Research instruments
The patients in both groups were asked to complete a basic personal information form, as well as several questionnaires including the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), Men's Health knowledge score, Partners in Health (PIH), and Decision Self-Efficacy Scale (DSES) before and 2-4 weeks after receiving the intervention measures. Additional examination data, such as prostate-specific antigen (PSA), uroflowmetry, and prostate sonography, were collected from medical records. A satisfaction questionnaire was also administered to the patients.
2.5 Statistical methods
SPSS was used for statistical analysis, including McNemar's test and independent sample t-test were used to compare and analyze the difference in the knowledge score, self-management, and decision-making self-efficacy between the experimental group and control group before and after the intervention; paired t-test was used to compare individuals before and after receiving intervention measures; Pearson's correlation was used to analyze the relationship among LUTS, knowledge score, self-management, and decision self-efficacy; Finally, multiple regression analysis to analyze the impact of using the chatbot on satisfaction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot-aid intervention | Experimental | Device: ChatbotChatbot-aid intervention group |
| Control group | No intervention | –Written routine nursing health education guidance intervention. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 45 years to 80 years old
- Prostate enlargement with lower urinary tract symptoms
- Need a mobile phone and willing to download the line chatbot
Key exclusion criteria (1 listed)
- Psychosis
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 |
|---|---|---|
| ChatbotThe AI chatbot is a kind of artificial intelligence technology that can help increase knowledge and understanding of men's health issues. That interacts with subjects through literal text and provides educational resources, advice, and assistance related to lifestyle changes. The chatbot is a valuable aid to increase men's health by providing information about enlarged prostate with urination problems and erectile dysfunction. | Device | Chatbot-aid intervention |
Primary outcome
Men's Health Knowledge Score
Time frame: Baseline and 2-4 weeks after intervention.
The 15 items of the Men's Health knowledge score are based on urination, prostate, and erectile dysfunction disorders. A total of 6 domains are to create men's health knowledge, which is used to evaluate the effectiveness of chatbot in promoting men's health knowledge.
Partners in Health Scale
Time frame: Baseline and 2-4 weeks after intervention.
The Partners in Health (PIH) is a validated,12 items questionnaire scored on a self-rated 9-point Likert scale (range: 0-8; higher scores indicate better self-management).
Decision Self-Efficacy Scale
Time frame: Baseline and 2-4 weeks after intervention.
The 11 items of the Decision Self-Efficacy Scale (DSES) used to assess the self-confidence of participants in their ability to make health decisions, ranged from 0 (not at all confident) to 4 (very confident).
1 secondary outcome
The evaluation of chatbot satisfaction.
Time frame: 2-4 weeks after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Background: PubMed 33685877Albarqouni L, Sanders S, Clark J, Tikkinen KAO, Glasziou P. Self-Management for Men With Lower Urinary Tract Symptoms: A Systematic Review and Meta-Analysis. Ann Fam Med. 2021 Mar-Apr;19(2):157-167. doi: 10.1370/afm.2609.
- Background: PubMed 1279218Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
- Background: PubMed 31107577Blanker MH, Brandenbarg P, Slijkhuis BGC, Steffens MG, van Balken MR, Jellema P. Development of an online personalized self-management intervention for men with uncomplicated LUTS. Neurourol Urodyn. 2019 Aug;38(6):1685-1691. doi: 10.1002/nau.24040. Epub 2019 May 20.
- Background: PubMed 32547642Bortnick E, Brown C, Simma-Chiang V, Kaplan SA. Modern best practice in the management of benign prostatic hyperplasia in the elderly. Ther Adv Urol. 2020 May 27;12:1756287220929486. doi: 10.1177/1756287220929486. eCollection 2020 Jan-Dec.
- Background: PubMed 29392976Calogero AE, Burgio G, Condorelli RA, Cannarella R, La Vignera S. Epidemiology and risk factors of lower urinary tract symptoms/benign prostatic hyperplasia and erectile dysfunction. Aging Male. 2019 Mar;22(1):12-19. doi: 10.1080/13685538.2018.1434772. Epub 2018 Feb 2.
- Background: PubMed 31474582Capogrosso P, Boeri L, Pozzi E, Ventimiglia E, Schifano N, Abbate C, Matloob R, Deho F, Montorsi F, Salonia A. Is It Compulsory to Investigate for Erectile Dysfunction in Patients Presenting for Low Urinary Tract Symptoms? Eur Urol Focus. 2021 Jan;7(1):172-177. doi: 10.1016/j.euf.2019.08.007. Epub 2019 Aug 30.
- Background: PubMed 28687936Chapple C, Castro-Diaz D, Chuang YC, Lee KS, Liao L, Liu SP, Wang J, Yoo TK, Chu R, Sumarsono B. Prevalence of Lower Urinary Tract Symptoms in China, Taiwan, and South Korea: Results from a Cross-Sectional, Population-Based Study. Adv Ther. 2017 Aug;34(8):1953-1965. doi: 10.1007/s12325-017-0577-9. Epub 2017 Jul 7.
- Background: PubMed 30140322Dumbraveanu I, Ceban E, Banov P. Lower urinary tract symptoms and erectile dysfunction in men from the Republic of Moldova. J Med Life. 2018 Apr-Jun;11(2):153-159.
- Background: PubMed 8254833Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
- Background: PubMed 32994064Ghose A, Roy S, Vasdev N, Olsburgh J, Dasgupta P. The Emerging Role of Artificial Intelligence in the Fight Against COVID-19. Eur Urol. 2020 Dec;78(6):775-776. doi: 10.1016/j.eururo.2020.09.031. Epub 2020 Sep 17.
- Background: PubMed 31019961Goldenthal SB, Portney D, Steppe E, Ghani K, Ellimoottil C. Assessing the feasibility of a chatbot after ureteroscopy. Mhealth. 2019 Mar 15;5:8. doi: 10.21037/mhealth.2019.03.01. eCollection 2019.
- Background: PubMed 28734864Griffith JW, Messersmith EE, Gillespie BW, Wiseman JB, Flynn KE, Kirkali Z, Kusek JW, Bavendam T, Cella D, Kreder KJ, Nero JJ, Corona ME, Bradley CS, Kenton KS, Helfand BT, Merion RM, Weinfurt KP; LURN Study Group. Reasons for Seeking Clinical Care for Lower Urinary Tract Symptoms: A Mixed Methods Study. J Urol. 2018 Feb;199(2):528-535. doi: 10.1016/j.juro.2017.07.067. Epub 2017 Jul 20.
- O'Connor, A. M. (2002). User manual-decisional self-efficacy scale. Ottawa: Ottawa Hospital Research Institute;1995 \[modified 2002\]Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Kuang-Kuo Chen, MD, PhD principal investigator
Cheng-Hsin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot in people with Benign Prostate Enlargement and Lower Urinary Tract Symptoms, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuang-Kuo Chen, MD, PhD (+886-2-2826-4400 ext. 8007, kkchen@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Men's Health Knowledge Score (time frame: Baseline and 2-4 weeks after intervention.). The study lists 3 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 NCT05765331, which also lists 17 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 13 Mar 2023.