- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394335
LLM in Urodynamic Education
Large Language Model (LLM) as a Tutor in Urodynamic Education: A Prospective Learning Curve Study Among Urology Residents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Urodynamic testing, including cystometry, pressure-flow studies, and electromyography, represents the gold standard for the objective evaluation of lower urinary tract dysfunction. Despite its clinical importance, urodynamic interpretation requires advanced analytical skills, including simultaneous assessment of vesical, abdominal, and detrusor pressures, recognition of technical artifacts, and application of established nomograms. Consequently, mastery of urodynamic interpretation during urology residency training remains challenging and highly dependent on variable case exposure and faculty availability.
This prospective, single-center educational study is designed to assess the effectiveness of a large language model (LLM) configured as an interactive educational tutor in improving urology residents' urodynamic interpretation skills and learning curve. The study aims to determine whether structured, AI-assisted mentorship can provide a standardized and scalable alternative to traditional apprenticeship-based training.
Eligible participants include urology residents without prior formal urodynamic course certification. The educational intervention utilizes a curated library of 45 fully anonymized urodynamic tracings performed in accordance with International Continence Society standards. These cases represent a balanced spectrum of normal findings and common urodynamic diagnoses, including bladder outlet obstruction, detrusor overactivity, and reduced bladder compliance. All cases are validated by experienced urologists prior to inclusion.
The training protocol consists of sequential phases: a baseline assessment (pre-test), structured theoretical instruction delivered via an LLM-based tutoring interface, supervised case analysis with artifact recognition, interactive mentored interpretation, an intermediate assessment (mid-test), reinforcement through independent interpretation followed by AI-guided debriefing, and a final post-test evaluation. Case difficulty across assessment phases is balanced using a stratified randomization approach to ensure equivalent technical complexity.
Participant performance is evaluated using a predefined 16-item objective scoring system assessing technical validity, numerical parameter interpretation, and diagnostic synthesis. All assessments are independently reviewed by two blinded urologists, with adjudication by a third expert in cases of disagreement. Changes in interpretation accuracy over time are used to quantify the learning curve associated with LLM-assisted education.
All urodynamic data are fully anonymized prior to use, and no patient-identifiable information is shared. Participation is voluntary, and written informed consent is obtained from all residents. The study is conducted following institutional ethical standards and aims to provide evidence for the role of large language models as interactive tutors in advanced medical education.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hüseyin Koçakgöl, MD
- Phone Number: +905062846185
- Email: hsynkocakgl@gmail.com
Study Locations
-
-
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Erzurum, Turkey (Türkiye)
- University of Health Sciences, Erzurum City Hospital, Department of Urology
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Contact:
- Hüseyin Koçakgöl, MD
- Phone Number: +905062846185
- Email: hsynkocakgl@gmail.com
-
Principal Investigator:
- Hüseyin Koçakgöl, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Urology residents currently enrolled in an accredited urology training program
No prior formal certification in urodynamic training
Exclusion Criteria:
Prior completion of a formal urodynamic training course
Declining to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LLM-Based Urodynamic Education
Participants receive a structured urodynamic education program supported by a large language model acting as an interactive tutor.
|
Participants receive a structured urodynamic education program supported by a large language model acting as an interactive tutor.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in Urodynamic Interpretation Accuracy
Time Frame: From baseline (pre-test) to post-test (approximately 4 weeks)
|
Change in urodynamic interpretation performance measured using a predefined 16-item objective scoring system assessing technical validity, numerical parameter interpretation, and diagnostic synthesis.
Scores are compared across pre-test, mid-test, and post-test assessments to evaluate learning curve progression.
|
From baseline (pre-test) to post-test (approximately 4 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hüseyin Koçakgöl, MD, University of Health Sciences, Erzurum City Hospital
Publications and helpful links
General Publications
- Frigerio M, Barba M, Cola A, Volontè S, Marino G, Regusci L, Sorice P, Ruggeri G, Castronovo F, Serati M, Torella M, Braga A. The Learning Curve of Urodynamics for the Evaluation of Lower Urinary Tract Symptoms. Medicina (Kaunas). 2022 Feb 23;58(3):341. doi: 10.3390/medicina58030341. PMID: 35334517; PMCID: PMC8955767.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- URO-LLM-UDS-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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