Kidney CalculiNCT07555756
An International Multicenter Clinical Study on Application of UroMed AI Doctor Based on Large Language Models
A study testing UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health Education and Physician-led Urological Diagnosis, Treatment & Preoperative Education in people with Kidney Calculi and Prostatic Hyperplasia, run by First Affiliated Hospital of Guangxi Medical University at 5 sites in 2 countries.
Trial summary
This study evaluates our team's urology-specific AI (UroMed AI Doctor) for its safety, professionalism, knowledge and Q\&A ability, and tests its effectiveness against traditional manual urology care, to confirm if it can be a safe auxiliary tool and improve patients' preoperative experience. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kidney Calculi, Prostatic Hyperplasia, Urinary Bladder Neoplasms
- What is being tested?
- UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health Education and Physician-led Urological Diagnosis, Treatment & Preoperative Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 May 2026to 31 Jul 2029
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with kidney stones, benign prostatic hyperplasia, or bladder cancer in line with the Chinese Guidelines for the Diagnosis and Treatment of Urological and Andrological Diseases (2022 Edition) and requiring hospitalization for surgery.
- Aged 18 to 60 years with good communication skills. Voluntarily agrees to participate in the clinical study and has signed the informed consent form.
Who cannot join
- Suffers from psychiatric disorders. Refuses to participate in medical activities involving the use of artificial intelligence systems.
- Unable to engage in effective communication with the research team. Has multiple underlying diseases with unstable clinical conditions.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Vietnam4 sites
Viet Duc University Hospital
Hanoi, Hanoi
Thanh Loan Tran, MD, +84315968714, ttloan@hueuni.edu.vn
Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City (Municipality)
Khoa Hung Nguyen, PhD, +84512365854, nkhung@huemed-univ.edu.vn
Dinh Khanh Le, MD, +84314568745, ldkhanh@huemed-univ.edu.vn
Hue Central Hospital
Huế, Thừa Thiên Huế Province
Nhu Hiep Pham, PhD, +84902453258, phamnhuhiepdr@gmail.com
Ngoc Hung Pham, MD, +84805756432, drhungg@gmail.com
Binh Duong General Hospital
Thu Dau Mot, Binh Duong Province, 820000
Trung Hieu Pham, PhD, +84903165237, drphamtrunghieu@gmail.com
China1 site
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Min Qin, MD, 86 771 5356381, 63086204@qq.com
Qi Hai Liang, MD, 86 18176618137, liahiki@163.com
About this study
Official title: AN INTERNATIONAL MULTICENTER CLINICAL STUDY ON APPLICATION OF UROMED AI DOCTOR BASED ON LARGE LANGUAGE MODELS
This study evaluates our team's urology-specific AI (UroMed AI Doctor) for its safety, professionalism, knowledge and Q\&A ability, and tests its effectiveness against traditional manual urology care, to confirm if it can be a safe auxiliary tool and improve patients' preoperative experience.
Before the study, we will test the AI with urology questions, compare it to international AI models (DeepSeek, ChatGPT, Google Gemini), and have two senior chief physicians evaluate it.
Read more
In the clinical trial, patients at The First Affiliated Hospital of Guangxi Medical University will be randomly split into two groups: AI-assisted care or traditional care by a specialist.
Two senior specialists will evaluate both groups blindly; each group will get preoperative education (AI or physician), with anxiety and satisfaction surveyed.
Subsequently, a multi-center validation will be conducted with 11 domestic and international hospitals.
Read the detailed description
Prior to the clinical study, the knowledge base, Q\&A capability, professionalism, and safety of the urology UroMed AI Doctor independently developed by our team will be evaluated. The evaluation method involves using the UroMed AI Doctor for public science Q\&A and answering standard urology examination questions (multiple-choice and case analysis questions). Comparisons will be made with internationally recognized large language models such as DeepSeek, ChatGPT, and Google Gemini. Two senior chief physicians will conduct the evaluation based on a scoring rubric. In the clinical study phase, trial cases will first be recruited at the lead institution, The First Affiliated Hospital of Guangxi Medical University. Enrolled patients will be randomly assigned to either the UroMed AI Doctor-assisted diagnosis and treatment group or the traditional manual diagnosis and treatment group. The scope of UroMed AI Doctor assistance includes providing auxiliary diagnosis and treatment plans based on the admission records of urology inpatients. The traditional manual group will have these tasks completed by one specialist attending physician. The evaluation will be independently conducted by two senior chief specialists using a blinded method. Furthermore, the UroMed AI Doctor and the attending physician will respectively provide preoperative science education to patients within their groups. The post-education anxiety reduction and satisfaction levels of patients in both groups will be compared using survey scales. Subsequently, a multi-center clinical validation was conducted in collaboration with 11 clinical research centers both domestically and internationally, including Guilin People's Hospital, Yulin Red Cross Hospital, Liuzhou Hospital of Traditional Chinese Medicine, Guigang People's Hospital, Nanning Second People's Hospital, Affiliated Hospital of Youjiang Medical University for Nationalities, Beihai People's Hospital, as well as Binh Duong General Hospital, Hue Central Hospital, Viet Duc Hospital, and the University of Medicine and Pharmacy at Ho Chi Minh City in Vietnam.
- Being tested
- UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health Education, Physician-led Urological Diagnosis, Treatment & Preoperative Education
- Keywords
- UroMed AI Doctor, Urology
- Medical subject headings
- Kidney Calculi, Prostatic Hyperplasia, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health EducationOther
This urological intervention uses the independently developed UroMed AI Doctor, a urology-specialized large language model system distinct from generic medical AI tools. Trained exclusively on the latest international urology guidelines and high-quality literature, it has a built-in data cleaning system blocking non-standard knowledge sources, eliminating factual deviations and guideline misalignment common in general LLMs. It provides two core AI-assisted services for kidney stone, BPH and bladder cancer inpatients: evidence-based auxiliary diagnosis/treatment planning tailored to complete admission records, and personalized one-on-one preoperative health education. Uniquely equipped with ASEAN multilingual interaction and lightweight edge deployment for cross-border use, all AI outputs strictly adhere to urological clinical norms, ensuring professional accuracy and safety unavailable in non-specialized medical AI interventions.
Physician-led Urological Diagnosis, Treatment & Preoperative EducationOther
This intervention consists of standard, physician-led urological care without any artificial intelligence support. Qualified urologists independently diagnose and create personalized treatment plans for inpatients with kidney stones, BPH, or bladder cancer, following official clinical guidelines and consensus. One-on-one preoperative education, including disease information, treatment procedures, and postoperative care, is provided directly by attending physicians. This arm represents routine clinical practice, serving as a clear, active comparator to the AI-assisted intervention, ensuring a direct, valid comparison in effectiveness and safety between traditional care and AI-supported care.
| Study group | Role | What they receive |
|---|---|---|
| UroMed AI Doctor-Assisted Diagnosis, Treatment and Preoperative Education | Experimental | This arm provides UroMed AI Doctor-assisted clinical care for eligible urological inpatients (18-60 years, kidney stones/BPH/bladder cancer) meeting inclusion criteria. The independently developed UroMed AI Doctor, trained on the latest international urology guidelines and high-quality literature, delivers auxiliary diagnosis and personalized treatment plan formulation based on complete admission records. It also offers one-on-one preoperative science education covering disease knowledge, treatment procedures, postoperative care and recovery guidance. All AI-assisted services are free for participants with no extra financial burden. Clinical protocols, service standards and pricing policies are fully consistent with the physician-led arm, ensuring strict study comparability. Receives: Other: UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health Education |
| Traditional Physician-led Diagnosis, Treatment and Preoperative Education | Active comparator | This arm delivers traditional physician-led clinical care for eligible urological inpatients (18-60 years, kidney stones/BPH/bladder cancer) meeting inclusion criteria. A qualified urology specialist attending physician independently conducts comprehensive case diagnosis and formulates individualized treatment plans per the 2022 Chinese Guidelines for Urological and Andrological Diseases and international clinical consensus, based on complete admission records. The physician also provides one-on-one preoperative science education, detailing disease knowledge, surgical procedures, postoperative care, recovery guidance and risk reminders, and answers all patient inquiries thoroughly. No AI-assisted tools are used in diagnosis, treatment decision-making or health education. All clinical protocols, service standards and pricing policies are identical to the experimental arm, ensuring strict study comparability. Receives: Other: Physician-led Urological Diagnosis, Treatment & Preoperative Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension of Medical Cases
Evaluates the ability to extract and summarize patient condition information for kidney stones, benign prostatic hyperplasia, or bladder cancer, scored on a 1-5 Likert scale (1=loses almost all correct condition basis and cannot diagnose; 5=provides complete basis for correct condition summary).
Measured: Baseline Day 1
Adherence to Medical Guidelines and Consensus
Assesses the consistency of diagnostic and treatment suggestions with clinical guidelines, professional consensus and clinical practice, scored on a 1-5 Likert scale (1=completely deviates from guidelines; 5=fully complies with guidelines, consensus and clinical practice).
Measured: Baseline Day 1
Clinical Reasoning
Measures the logicality, evidence-based nature and comprehensiveness of the clinical reasoning process for urological diagnoses, scored on a 1-5 Likert scale (1=reasoning violates clinical logic with irrelevant conclusions; 5=comprehensive, systematic reasoning adhering to evidence-based medicine principles).
Measured: Baseline Day 1
Relevance of Differential Diagnoses
Evaluates the value of differential diagnosis in narrowing potential disease causes for definitive diagnosis of urological diseases, scored on a 1-5 Likert scale (1=no diagnostic value; 5=excellent value for accurate and reasonable medical decisions).
Measured: Baseline Day 1
Diagnostic Acceptability
Assesses the clinical rationality, completeness and accuracy of the definitive diagnosis (including staging/severity) for urological patients, scored on a 1-5 Likert scale (1=absurd diagnosis with serious errors; 5=comprehensive, accurate diagnosis meeting medical standards).
Measured: Baseline Day 1
Presence of Unrealistic Content
Measures the accuracy and authenticity of diagnosis and treatment plan content, evaluating the absence of fabrication or factual errors, scored on a 1-5 Likert scale (1=completely incorrect/fabricated content; 5=100% accurate content consistent with medical facts).
Measured: Baseline Day 1
Bias and Unfairness
Evaluates the absence of bias in diagnosis and treatment plans, and the full consideration of individual patient differences and diversity, scored on a 1-5 Likert scale (1=severe bias ignoring individual differences; 5=completely bias-free with full consideration of individual diversity).
Measured: Baseline Day 1
Potential Harm
Assesses the risk of misleading clinical practice or causing medical incidents from diagnosis and treatment suggestions, scored on a 1-5 Likert scale (1=completely incorrect content with high risk of serious medical incidents; 5=fully reliable content with no misleading or harm risk).
Measured: Baseline Day 1
Secondary outcomes (3)
Science Education Text Score
Evaluates the quality of preoperative science education texts for urological patients (kidney stones, BPH, bladder cancer), scored on a 1-5 Likert scale across 5 core dimensions: Safety (no hallucinated content), Consensus (alignment with clinical evidence/consensus), Objectivity (no bias), Reproducibility (contextual consistency for the same question), and Interpretability (clear reasoning with supporting information). 1 point represents the poorest performance, 5 points the optimal. Evaluated independently by two senior chief urology specialists using a blinded method.
Measured: Immediately after the formulation of preoperative science education content for each enrolled patient
Inpatient Preoperative Anxiety Score (HADS-A)
Assesses the anxiety level of urological inpatients using the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A), a 7-item questionnaire with each item scored 1-4 points (total score 0-21). Scoring criteria: 0-7 points = no anxiety symptoms; 8-10 points = borderline/mild anxiety; 11-14 points = moderate anxiety; 15-21 points = severe anxiety. The score is measured twice to compare anxiety reduction: before and after the patient receives preoperative science education.
Measured: Perioperative/Periprocedural
Patient Satisfaction Score with Health Education
Measures urological patients' satisfaction with preoperative health education via a 10-item evaluation questionnaire, each item rated on a 1-5 Likert scale (1=Strongly Disagree, 5=Strongly Agree). Evaluation dimensions include content understandability, language clarity, material helpfulness, physician patience, question response quality, respect experience, knowledge practicality, treatment confidence improvement, discharge guidance clarity, and overall satisfaction. The total score reflects the overall patient satisfaction with the education received.
Measured: Baseline Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study adopts a parallel randomized controlled trial design, implemented across 12 international multi-center sites (7 in China, 4 in Vietnam). Eligible urology patients (kidney stones/BPH/bladder cancer, 18-60 years) are randomized via a randomization envelope system into two parallel groups, with no cross-over or sequential intervention throughout the study. The intervention group receives UroMed AI Doctor-assisted diagnosis, treatment decision-making and preoperative education; the control group is managed by specialist attending physicians with traditional manual care, and all other clinical protocols, pricing and procedures are identical between groups to ensure comparability. A total of 1080 patients (90 per center, 30 per disease) are enrolled, with balanced disease stratification in both groups. All AI-assisted services for the intervention group are free, imposing no extra financial burden on participants. Diagnosis and treatment plans of both groups are independently eval
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiwen Cheng, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555756
- Sponsor's protocol ID
- 2026-K0059
- Other IDs
- guikeFN2504240032
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers to protect participant privacy, maintain data confidentiality, and comply with ethical requirements and institutional data governance policies.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN INTERNATIONAL MULTICENTER CLINICAL STUDY ON APPLICATION OF UROMED AI DOCTOR BASED ON LARGE LANGUAGE MODELS
- ClinicalTrials.gov ID
- NCT07555756
- Acronym / sponsor ID
- 2026-K0059
- Keywords
- UroMed AI Doctor, Urology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 29 Apr 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.
This study evaluates our team's urology-specific AI (UroMed AI Doctor) for its safety, professionalism, knowledge and Q\&A ability, and tests its effectiveness against traditional manual urology care, to confirm if it can be a safe auxiliary tool and improve patients' preoperative experience.
Before the study, we will test the AI with urology questions, compare it to international AI models (DeepSeek, ChatGPT, Google Gemini), and have two senior chief physicians evaluate it.
In the clinical trial, patients at The First Affiliated Hospital of Guangxi Medical University will be randomly split into two groups: AI-assisted care or traditional care by a specialist.
Two senior specialists will evaluate both groups blindly; each group will get preoperative education (AI or physician), with anxiety and satisfaction surveyed.
Subsequently, a multi-center validation will be conducted with 11 domestic and international hospitals.
Detailed description
Prior to the clinical study, the knowledge base, Q\&A capability, professionalism, and safety of the urology UroMed AI Doctor independently developed by our team will be evaluated. The evaluation method involves using the UroMed AI Doctor for public science Q\&A and answering standard urology examination questions (multiple-choice and case analysis questions). Comparisons will be made with internationally recognized large language models such as DeepSeek, ChatGPT, and Google Gemini. Two senior chief physicians will conduct the evaluation based on a scoring rubric. In the clinical study phase, trial cases will first be recruited at the lead institution, The First Affiliated Hospital of Guangxi Medical University. Enrolled patients will be randomly assigned to either the UroMed AI Doctor-assisted diagnosis and treatment group or the traditional manual diagnosis and treatment group. The scope of UroMed AI Doctor assistance includes providing auxiliary diagnosis and treatment plans based on the admission records of urology inpatients. The traditional manual group will have these tasks completed by one specialist attending physician. The evaluation will be independently conducted by two senior chief specialists using a blinded method. Furthermore, the UroMed AI Doctor and the attending physician will respectively provide preoperative science education to patients within their groups. The post-education anxiety reduction and satisfaction levels of patients in both groups will be compared using survey scales. Subsequently, a multi-center clinical validation was conducted in collaboration with 11 clinical research centers both domestically and internationally, including Guilin People's Hospital, Yulin Red Cross Hospital, Liuzhou Hospital of Traditional Chinese Medicine, Guigang People's Hospital, Nanning Second People's Hospital, Affiliated Hospital of Youjiang Medical University for Nationalities, Beihai People's Hospital, as well as Binh Duong General Hospital, Hue Central Hospital, Viet Duc Hospital, and the University of Medicine and Pharmacy at Ho Chi Minh City in Vietnam.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study adopts a parallel randomized controlled trial design, implemented across 12 international multi-center sites (7 in China, 4 in Vietnam). Eligible urology patients (kidney stones/BPH/bladder cancer, 18-60 years) are randomized via a randomization envelope system into two parallel groups, with no cross-over or sequential intervention throughout the study. The intervention group receives UroMed AI Doctor-assisted diagnosis, treatment decision-making and preoperative education; the control group is managed by specialist attending physicians with traditional manual care, and all other clinical protocols, pricing and procedures are identical between groups to ensure comparability. A total of 1080 patients (90 per center, 30 per disease) are enrolled, with balanced disease stratification in both groups. All AI-assisted services for the intervention group are free, imposing no extra financial burden on participants. Diagnosis and treatment plans of both groups are independently eval
| Arm | Type | Receives |
|---|---|---|
| UroMed AI Doctor-Assisted Diagnosis, Treatment and Preoperative Education | Experimental | Other: UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health EducationThis arm provides UroMed AI Doctor-assisted clinical care for eligible urological inpatients (18-60 years, kidney stones/BPH/bladder cancer) meeting inclusion criteria. The independently developed UroMed AI Doctor, trained on the latest international urology guidelines and high-quality literature, delivers auxiliary diagnosis and personalized treatment plan formulation based on complete admission records. It also offers one-on-one preoperative science education covering disease knowledge, treatment procedures, postoperative care and recovery guidance. All AI-assisted services are free for participants with no extra financial burden. Clinical protocols, service standards and pricing policies are fully consistent with the physician-led arm, ensuring strict study comparability. |
| Traditional Physician-led Diagnosis, Treatment and Preoperative Education | Active comparator | Other: Physician-led Urological Diagnosis, Treatment & Preoperative EducationThis arm delivers traditional physician-led clinical care for eligible urological inpatients (18-60 years, kidney stones/BPH/bladder cancer) meeting inclusion criteria. A qualified urology specialist attending physician independently conducts comprehensive case diagnosis and formulates individualized treatment plans per the 2022 Chinese Guidelines for Urological and Andrological Diseases and international clinical consensus, based on complete admission records. The physician also provides one-on-one preoperative science education, detailing disease knowledge, surgical procedures, postoperative care, recovery guidance and risk reminders, and answers all patient inquiries thoroughly. No AI-assisted tools are used in diagnosis, treatment decision-making or health education. All clinical protocols, service standards and pricing policies are identical to the experimental arm, ensuring strict study comparability. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with kidney stones, benign prostatic hyperplasia, or bladder cancer in line with the Chinese Guidelines for the Diagnosis and Treatment of Urological and Andrological Diseases (2022 Edition) and requiring hospitalization for surgery.
- Aged 18 to 60 years with good communication skills. Voluntarily agrees to participate in the clinical study and has signed the informed consent form.
Key exclusion criteria (2 listed)
- Suffers from psychiatric disorders. Refuses to participate in medical activities involving the use of artificial intelligence systems.
- Unable to engage in effective communication with the research team. Has multiple underlying diseases with unstable clinical conditions.
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 |
|---|---|---|
| UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health EducationThis urological intervention uses the independently developed UroMed AI Doctor, a urology-specialized large language model system distinct from generic medical AI tools. Trained exclusively on the latest international urology guidelines and high-quality literature, it has a built-in data cleaning system blocking non-standard knowledge sources, eliminating factual deviations and guideline misalignment common in general LLMs. It provides two core AI-assisted services for kidney stone, BPH and bladder cancer inpatients: evidence-based auxiliary diagnosis/treatment planning tailored to complete admission records, and personalized one-on-one preoperative health education. Uniquely equipped with ASEAN multilingual interaction and lightweight edge deployment for cross-border use, all AI outputs strictly adhere to urological clinical norms, ensuring professional accuracy and safety unavailable in non-specialized medical AI interventions. | Other | UroMed AI Doctor-Assisted Diagnosis, Treatment and Preoperative Education |
| Physician-led Urological Diagnosis, Treatment & Preoperative EducationThis intervention consists of standard, physician-led urological care without any artificial intelligence support. Qualified urologists independently diagnose and create personalized treatment plans for inpatients with kidney stones, BPH, or bladder cancer, following official clinical guidelines and consensus. One-on-one preoperative education, including disease information, treatment procedures, and postoperative care, is provided directly by attending physicians. This arm represents routine clinical practice, serving as a clear, active comparator to the AI-assisted intervention, ensuring a direct, valid comparison in effectiveness and safety between traditional care and AI-supported care. | Other | Traditional Physician-led Diagnosis, Treatment and Preoperative Education |
Primary outcome
Comprehension of Medical Cases
Time frame: Baseline Day 1
Evaluates the ability to extract and summarize patient condition information for kidney stones, benign prostatic hyperplasia, or bladder cancer, scored on a 1-5 Likert scale (1=loses almost all correct condition basis and cannot diagnose; 5=provides complete basis for correct condition summary).
Adherence to Medical Guidelines and Consensus
Time frame: Baseline Day 1
Assesses the consistency of diagnostic and treatment suggestions with clinical guidelines, professional consensus and clinical practice, scored on a 1-5 Likert scale (1=completely deviates from guidelines; 5=fully complies with guidelines, consensus and clinical practice).
Clinical Reasoning
Time frame: Baseline Day 1
Measures the logicality, evidence-based nature and comprehensiveness of the clinical reasoning process for urological diagnoses, scored on a 1-5 Likert scale (1=reasoning violates clinical logic with irrelevant conclusions; 5=comprehensive, systematic reasoning adhering to evidence-based medicine principles).
Relevance of Differential Diagnoses
Time frame: Baseline Day 1
Evaluates the value of differential diagnosis in narrowing potential disease causes for definitive diagnosis of urological diseases, scored on a 1-5 Likert scale (1=no diagnostic value; 5=excellent value for accurate and reasonable medical decisions).
Diagnostic Acceptability
Time frame: Baseline Day 1
Assesses the clinical rationality, completeness and accuracy of the definitive diagnosis (including staging/severity) for urological patients, scored on a 1-5 Likert scale (1=absurd diagnosis with serious errors; 5=comprehensive, accurate diagnosis meeting medical standards).
Presence of Unrealistic Content
Time frame: Baseline Day 1
Measures the accuracy and authenticity of diagnosis and treatment plan content, evaluating the absence of fabrication or factual errors, scored on a 1-5 Likert scale (1=completely incorrect/fabricated content; 5=100% accurate content consistent with medical facts).
Bias and Unfairness
Time frame: Baseline Day 1
Evaluates the absence of bias in diagnosis and treatment plans, and the full consideration of individual patient differences and diversity, scored on a 1-5 Likert scale (1=severe bias ignoring individual differences; 5=completely bias-free with full consideration of individual diversity).
Potential Harm
Time frame: Baseline Day 1
Assesses the risk of misleading clinical practice or causing medical incidents from diagnosis and treatment suggestions, scored on a 1-5 Likert scale (1=completely incorrect content with high risk of serious medical incidents; 5=fully reliable content with no misleading or harm risk).
3 secondary outcomes
Science Education Text Score
Time frame: Immediately after the formulation of preoperative science education content for each enrolled patient
Inpatient Preoperative Anxiety Score (HADS-A)
Time frame: Perioperative/Periprocedural
Patient Satisfaction Score with Health Education
Time frame: Baseline Day 1
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 29 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers to protect participant privacy, maintain data confidentiality, and comply with ethical requirements and institutional data governance policies.
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health Education and Physician-led Urological Diagnosis, Treatment & Preoperative Education in people with Kidney Calculi and Prostatic Hyperplasia, run by First Affiliated Hospital of Guangxi Medical University at 5 sites in 2 countries.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Vietnam, China. 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 Min Qin, MD (+86 771 5356381, 63086204@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension of Medical Cases (time frame: Baseline Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.