Kidney Calculi, Prostatic Hyperplasia, Urinary Bladder Neoplasms
Conditions
Keywords
UroMed AI Doctor, Urology
Brief 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. 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.
Interventions
OTHERUroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health Education
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.
OTHERPhysician-led Urological Diagnosis, Treatment & Preoperative Education
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.
Sponsors
First Affiliated Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehension of Medical Cases | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Science Education Text Score | Immediately after the formulation of preoperative science education content for each enrolled patient | 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. |
| Inpatient Preoperative Anxiety Score (HADS-A) | Perioperative/Periprocedural | 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. |
| Patient Satisfaction Score with Health Education | Baseline Day 1 | 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. |
Countries
China, Vietnam
Contacts
CONTACTMin Qin, MD
CONTACTQi Hai Liang, MD
Outcome results
None listed