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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07394335
Study groupRoleWhat they receive
LLM-Based Urodynamic EducationExperimentalParticipants 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.

  1. 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.

  1. First posted6 Feb 2026
  2. Study start24 Jul 2026
  3. Primary completion24 Aug 2026
  4. Study completion24 Aug 2026

Resources

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)
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

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.

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