An International Multicenter Clinical Study on Application of UroMed AI Doctor Based on Large Language Models

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFirst Affiliated Hospital of Guangxi Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Suffers from psychiatric disorders. Refuses to participate in medical activities involving the use of artificial intelligence systems.

Trial design

Design model

Parallel

Treatments tested in this trial

  • UroMed AI Doctor-assisted Urological Diagnosis, Treatment and Preoperative Health Education

    Other intervention

    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 Education

    Other intervention

    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.

Treatment groups

1,080 Participants
are divided into 2 treatment groups
Group A: UroMed AI Doctor-Assisted Diagnosis, Treatment and Preoperative EducationExperimental treatment 1 intervention
Group B: Traditional Physician-led Diagnosis, Treatment and Preoperative EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline Day 1
2

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).

Time frame
Baseline Day 1
3

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).

Time frame
Baseline Day 1
4

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).

Time frame
Baseline Day 1

Secondary outcomes

1

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.

Time frame
Immediately after the formulation of preoperative science education content for each enrolled patient
2

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.

Time frame
Perioperative/Periprocedural
3

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.

Time frame
Baseline Day 1

Other outcomes

Sponsors and contacts

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