Urodynamic Interpretation SkillsNCT07394335
LLM in Urodynamic Education
A study testing LLM-Based Urodynamic Tutoring in people with Urodynamic Interpretation Skills, run by Huseyin Kocakgol at 1 site in Turkey (Türkiye).
Trial summary
Urodynamic investigations, including cystometry and pressure-flow studies, are considered the gold standard for the objective diagnosis of lower urinary tract dysfunction according to current international guidelines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urodynamic Interpretation Skills
- What is being tested?
- LLM-Based Urodynamic Tutoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jul 2026to 24 Aug 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Urology residents currently enrolled in an accredited urology training program
- No prior formal certification in urodynamic training
Who cannot join
- Prior completion of a formal urodynamic training course
- Declining to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Erzurum City Hospital, Department of Urology
Erzurum
About this study
Official title: Large Language Model (LLM) as a Tutor in Urodynamic Education: A Prospective Learning Curve Study Among Urology Residents
Urodynamic investigations, including cystometry and pressure-flow studies, are considered the gold standard for the objective diagnosis of lower urinary tract dysfunction according to current international guidelines. However, accurate interpretation requires simultaneous analysis of multiple pressure and flow parameters, verification of technical study quality, and structured application of International Continence Society (ICS) diagnostic criteria, making pressure-flow urodynamic interpretation one of the most challenging skills to standardize during urology residency training. Traditional training largely depends on apprenticeship-based exposure, which is highly variable across training centers. The primary aim of this prospective educational study is to evaluate the effect of a structured, modular, large language model (LLM)-assisted tutoring program on urology residents' pressure-flow urodynamic interpretation performance, using a case-based, expert-referenced assessment protocol administered at three time points (pre-test, mid-test, and post-test).
Read the detailed description
Pressure-flow urodynamic interpretation requires simultaneous assessment of numeric parameters (PdetQmax, Qmax, cystometric capacity, voided volume), derived indices (BOOI, BCI), technical quality verification, and integration of ICS-defined diagnostic criteria across seven diagnostic categories (bladder outlet obstruction, detrusor overactivity, detrusor underactivity, hypocompliant bladder, hypercompliant bladder, atonic bladder, and normal urodynamic study). Mastery of this skill during residency training remains highly dependent on faculty availability, case exposure, and the quality of feedback provided, limiting standardization across training environments.
This prospective, single-center, assessor-blinded educational intervention study evaluates whether a standardized, modular LLM-assisted tutoring program can improve residents' diagnostic agreement with an expert-derived reference standard over the course of training. Eligible participants are urology residents currently enrolled in an accredited urology training program without prior formal urodynamic course certification.
A total of 83 archived pressure-flow urodynamic studies, performed using a single urodynamic system, were screened; after exclusion of studies with missing summary data, inadequate technical quality, or pediatric age, a final pool of 65 fully anonymized studies was retained. From this pool, two mutually exclusive case sets were constructed: an assessment case pool of 30 cases (10 cases each for pre-test, mid-test, and post-test, balanced for diagnostic category distribution and sex) and an educational case pool used exclusively during training modules. No case was used in more than one assessment time point or in both pools, minimizing the influence of case familiarity on assessed performance.
The reference standard for all assessment cases was established independently of the educational intervention: two experienced urologists, blinded to each other's assessments, independently classified each case across the seven diagnostic categories; disagreements were adjudicated by a third independent experienced urologist, whose decision served as the final reference standard. This reference standard was finalized prior to the start of resident assessments and remained unchanged throughout the study.
The educational intervention consists of five sequential modules delivered via standardized prompts using the Gemini LLM: (1A) theoretical instruction on ICS terminology and pressure-flow principles without case analysis; (1B) structured conceptual reinforcement addressing operational thresholds, sex-specific interpretation, and ambiguous findings; (2) observational learning, in which the LLM models expert-level step-by-step interpretation of training cases; (2B) visual pattern recognition, focused specifically on graphical identification of detrusor overactivity from filling-phase pressure curves; and (3) interactive learning, in which residents independently interpret cases before receiving structured comparative feedback against the LLM's structured assessment. All residents completed modules in an identical sequence using identical materials.
Resident performance is assessed at three time points - pre-test (before the intervention), mid-test (after modules 1A, 1B, 2, and 2B), and post-test (after module 3) - each comprising 10 independent pressure-flow cases evaluated under proctored, closed-book conditions without access to LLMs, reference materials, or prior assessment feedback. For each case, residents record numeric parameters, derived indices (BOOI, BCI), classification across the seven diagnostic categories (Present/Absent for detrusor overactivity, detrusor underactivity, hypocompliant bladder, hypercompliant bladder, atonic bladder, and normal urodynamic study; Present/Absent/Indeterminate for bladder outlet obstruction, with an additional Not Applicable option reserved for female patients), and an overall technical quality assessment.
The primary outcome is the resident-level pooled, unweighted Cohen's kappa between resident classifications and the expert reference standard, calculated by combining all diagnostic category decisions per resident per time point (10 cases × 7 categories, with female bladder outlet obstruction decisions excluded) into a single multicategory agreement table. Secondary outcomes include numeric extraction accuracy, BOOI/BCI calculation accuracy, technical quality assessment agreement, and diagnosis-specific agreement, each evaluated across the three time points. Change in pooled kappa across pre-test, mid-test, and post-test is analyzed using a within-subject repeated-measures approach.
All urodynamic data were fully anonymized prior to use, and no patient-identifiable information was retained or shared. Participation was voluntary, and written informed consent was obtained from all residents. The study was conducted in accordance with the Declaration of Helsinki and approved by the institutional non-interventional clinical research ethics committee.
- Conditions
- Urodynamic Interpretation Skills
- Being tested
- LLM-Based Urodynamic Tutoring
- Keywords
- Urodynamic Education, Learning Curve, Urology Residency, Large Language Models
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM-Based Urodynamic TutoringOther
Also called LLM-Based Urodynamic Education
Participants receive a structured urodynamic education program supported by a large language model acting as an interactive tutor.
| Study group | Role | What they receive |
|---|---|---|
| LLM-Based Urodynamic Education | Experimental | Participants receive a structured urodynamic education program supported by a large language model acting as an interactive tutor. Receives: Other: LLM-Based Urodynamic Tutoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pressure-Flow Urodynamic Interpretation Agreement (Pooled Cohen's Kappa)
Resident-level agreement with an expert-derived reference standard, quantified as a pooled, unweighted Cohen's kappa combining classification decisions across seven diagnostic categories (bladder outlet obstruction, detrusor overactivity, detrusor underactivity, hypocompliant bladder, hypercompliant bladder, atonic bladder, and normal urodynamic study) for 10 cases per assessment (70 categorical decisions per resident per time point, with female bladder outlet obstruction decisions excluded). Kappa values range from -1 to 1, with higher values indicating greater agreement with the reference standard (values ≤0 indicating agreement no better than chance, and 1 indicating perfect agreement). Values are compared across pre-test, mid-test, and post-test assessments to evaluate learning curve progression.
Measured: From baseline (pre-test) to mid-test and post-test; individualized per resident based on completion of the corresponding training modules, with total duration from pre-test to post-test ranging from approximately 2 to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start24 Jul 2026
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urodynamic Interpretation SkillsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants undergo a single-arm, prospective educational intervention with repeated assessments (pre-test, mid-test, and post-test) to evaluate changes in urodynamic interpretation performance over time.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huseyin Kocakgol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huseyin Kocakgol, Erzurum City Hospital
- Investigators
- Hüseyin Koçakgöl, MD, Principal investigator, University of Health Sciences, Erzurum City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394335
- Sponsor's protocol ID
- URO-LLM-UDS-2026
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves a small sample size and focuses on educational performance outcomes. All analyses will be reported in aggregate form without identifiable individual-level data.
Publications
Frigerio M, Barba M, Cola A, Volonte 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.
PubMed 35334517
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Language Model (LLM) as a Tutor in Urodynamic Education: A Prospective Learning Curve Study Among Urology Residents
- ClinicalTrials.gov ID
- NCT07394335
- Acronym / sponsor ID
- URO-LLM-UDS-2026
- Conditions
- Urodynamic Interpretation Skills
- Keywords
- Urodynamic Education, Learning Curve, Urology Residency, Large Language Models
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Huseyin KocakgolUniversity, hospital or other
- Study start
- 24 Jul 2026 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 6 Feb 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.
Urodynamic investigations, including cystometry and pressure-flow studies, are considered the gold standard for the objective diagnosis of lower urinary tract dysfunction according to current international guidelines. However, accurate interpretation requires simultaneous analysis of multiple pressure and flow parameters, verification of technical study quality, and structured application of International Continence Society (ICS) diagnostic criteria, making pressure-flow urodynamic interpretation one of the most challenging skills to standardize during urology residency training. Traditional training largely depends on apprenticeship-based exposure, which is highly variable across training centers. The primary aim of this prospective educational study is to evaluate the effect of a structured, modular, large language model (LLM)-assisted tutoring program on urology residents' pressure-flow urodynamic interpretation performance, using a case-based, expert-referenced assessment protocol administered at three time points (pre-test, mid-test, and post-test).
Detailed description
Pressure-flow urodynamic interpretation requires simultaneous assessment of numeric parameters (PdetQmax, Qmax, cystometric capacity, voided volume), derived indices (BOOI, BCI), technical quality verification, and integration of ICS-defined diagnostic criteria across seven diagnostic categories (bladder outlet obstruction, detrusor overactivity, detrusor underactivity, hypocompliant bladder, hypercompliant bladder, atonic bladder, and normal urodynamic study). Mastery of this skill during residency training remains highly dependent on faculty availability, case exposure, and the quality of feedback provided, limiting standardization across training environments.
This prospective, single-center, assessor-blinded educational intervention study evaluates whether a standardized, modular LLM-assisted tutoring program can improve residents' diagnostic agreement with an expert-derived reference standard over the course of training. Eligible participants are urology residents currently enrolled in an accredited urology training program without prior formal urodynamic course certification.
A total of 83 archived pressure-flow urodynamic studies, performed using a single urodynamic system, were screened; after exclusion of studies with missing summary data, inadequate technical quality, or pediatric age, a final pool of 65 fully anonymized studies was retained. From this pool, two mutually exclusive case sets were constructed: an assessment case pool of 30 cases (10 cases each for pre-test, mid-test, and post-test, balanced for diagnostic category distribution and sex) and an educational case pool used exclusively during training modules. No case was used in more than one assessment time point or in both pools, minimizing the influence of case familiarity on assessed performance.
The reference standard for all assessment cases was established independently of the educational intervention: two experienced urologists, blinded to each other's assessments, independently classified each case across the seven diagnostic categories; disagreements were adjudicated by a third independent experienced urologist, whose decision served as the final reference standard. This reference standard was finalized prior to the start of resident assessments and remained unchanged throughout the study.
The educational intervention consists of five sequential modules delivered via standardized prompts using the Gemini LLM: (1A) theoretical instruction on ICS terminology and pressure-flow principles without case analysis; (1B) structured conceptual reinforcement addressing operational thresholds, sex-specific interpretation, and ambiguous findings; (2) observational learning, in which the LLM models expert-level step-by-step interpretation of training cases; (2B) visual pattern recognition, focused specifically on graphical identification of detrusor overactivity from filling-phase pressure curves; and (3) interactive learning, in which residents independently interpret cases before receiving structured comparative feedback against the LLM's structured assessment. All residents completed modules in an identical sequence using identical materials.
Resident performance is assessed at three time points - pre-test (before the intervention), mid-test (after modules 1A, 1B, 2, and 2B), and post-test (after module 3) - each comprising 10 independent pressure-flow cases evaluated under proctored, closed-book conditions without access to LLMs, reference materials, or prior assessment feedback. For each case, residents record numeric parameters, derived indices (BOOI, BCI), classification across the seven diagnostic categories (Present/Absent for detrusor overactivity, detrusor underactivity, hypocompliant bladder, hypercompliant bladder, atonic bladder, and normal urodynamic study; Present/Absent/Indeterminate for bladder outlet obstruction, with an additional Not Applicable option reserved for female patients), and an overall technical quality assessment.
The primary outcome is the resident-level pooled, unweighted Cohen's kappa between resident classifications and the expert reference standard, calculated by combining all diagnostic category decisions per resident per time point (10 cases × 7 categories, with female bladder outlet obstruction decisions excluded) into a single multicategory agreement table. Secondary outcomes include numeric extraction accuracy, BOOI/BCI calculation accuracy, technical quality assessment agreement, and diagnosis-specific agreement, each evaluated across the three time points. Change in pooled kappa across pre-test, mid-test, and post-test is analyzed using a within-subject repeated-measures approach.
All urodynamic data were fully anonymized prior to use, and no patient-identifiable information was retained or shared. Participation was voluntary, and written informed consent was obtained from all residents. The study was conducted in accordance with the Declaration of Helsinki and approved by the institutional non-interventional clinical research ethics committee.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants undergo a single-arm, prospective educational intervention with repeated assessments (pre-test, mid-test, and post-test) to evaluate changes in urodynamic interpretation performance over time.
| Arm | Type | Receives |
|---|---|---|
| LLM-Based Urodynamic Education | Experimental | Other: LLM-Based Urodynamic TutoringParticipants receive a structured urodynamic education program supported by a large language model acting as an interactive tutor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Urology residents currently enrolled in an accredited urology training program
- No prior formal certification in urodynamic training
Key exclusion criteria (2 listed)
- Prior completion of a formal urodynamic training course
- Declining to provide informed consent
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 |
|---|---|---|
| LLM-Based Urodynamic TutoringAlso: LLM-Based Urodynamic EducationParticipants receive a structured urodynamic education program supported by a large language model acting as an interactive tutor. | Other | LLM-Based Urodynamic Education |
Primary outcome
Change in Pressure-Flow Urodynamic Interpretation Agreement (Pooled Cohen's Kappa)
Time frame: From baseline (pre-test) to mid-test and post-test; individualized per resident based on completion of the corresponding training modules, with total duration from pre-test to post-test ranging from approximately 2 to 4 weeks.
Resident-level agreement with an expert-derived reference standard, quantified as a pooled, unweighted Cohen's kappa combining classification decisions across seven diagnostic categories (bladder outlet obstruction, detrusor overactivity, detrusor underactivity, hypocompliant bladder, hypercompliant bladder, atonic bladder, and normal urodynamic study) for 10 cases per assessment (70 categorical decisions per resident per time point, with female bladder outlet obstruction decisions excluded). Kappa values range from -1 to 1, with higher values indicating greater agreement with the reference standard (values ≤0 indicating agreement no better than chance, and 1 indicating perfect agreement). Values are compared across pre-test, mid-test, and post-test assessments to evaluate learning curve progression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 35334517Frigerio M, Barba M, Cola A, Volonte 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves a small sample size and focuses on educational performance outcomes. All analyses will be reported in aggregate form without identifiable individual-level data.
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.
Hüseyin Koçakgöl, MD principal investigator
University of Health Sciences, Erzurum City 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 LLM-Based Urodynamic Tutoring in people with Urodynamic Interpretation Skills, run by Huseyin Kocakgol at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 4 Sep 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pressure-Flow Urodynamic Interpretation Agreement (Pooled Cohen's Kappa) (time frame: From baseline (pre-test) to mid-test and post-test; individualized per resident based on completion of the corresponding training modules, with total duration from pre-test to post-test ranging from approximately 2 to 4 weeks.). 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 NCT07394335, which also lists 1 linked publication.
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 4 Sep 2026.