In patients with lower urinary tract disorders, their chief complaints and symptoms of the genitourinary system often fail to reflect the true pathological and physiological changes in the lower urinary tract. To address this challenge, urodynamic study (UDS) examination, as an important functional adjunctive test, primarily relies on the fundamental principles and methods of fluid mechanics and electrophysiology to detect pressures, flow rates, and bioelectric activities of the urinary tract. The quality of UDS is crucial as low-quality results may mislead clinical decisions by urologists. However, current methods for quality control of UDS are extremely limited. Currently, urodynamic examinations are mainly guided by the "Good Urodynamic Practices" (GUP) established by the International Continence Society (ICS) [1], and domestic guidelines, to standardize operations and ensure quality control. Existing literature reviews indicate that the quality of UDS is generally poor. Currently, most research on urodynamic quality control in China is regional, with small sample sizes, necessitating a large-scale national multicenter study to fill existing research gaps and comprehensively understand the quality of urodynamic examinations in China.
Moreover, research also indicates that another key factor influencing the quality of UDS is whether UDS operators strictly adhere to the GUP guidelines established by the ICS. Educational and training backgrounds, as well as operational techniques and work situations, can significantly affect examination results. UDS must be performed by staff who have undergone standardized training and are familiar with UDS theoretical knowledge to obtain reliable patient examination results. However, research on demographic information, health-related issues, educational and training backgrounds, and work situations of UDS operators remains scarce.
We designed this study to conduct a comprehensive retrospective analysis of the national UDS quality control by evaluating the occurrence of UDS artefacts and errors. We also assessed the demographic characteristics of UDS operators in China, including general information, health-related information, urodynamic work issues, and continuing education status, and explored the correlation between the occurrence rates of UDS artefacts and errors and the demographic characteristics of UDS operators, elucidating the importance of operator-related factors in improving the accuracy of UDS.

Using a cross-sectional stratified sampling method, representative UDS traces and reports nationwide were selected from May 2022 to June 2023. According to the sample size formula: Z2 a/2p (1-p) DEFF/d2 (where a = 0.05, Za/2 = 1.96, p = 0.5, design effect [DEFF] = 5.3, d = 0.05). Increase the sample size to 20% of the minimum sample size for oversampling. A sample size of 2460 is required. Eventually, 50 centers provided a total of 2600 UDS traces and reports. We selected only UDS artefacts and errors that could be retrospectively identified from traces and reports and defined or quantified according to GUP guidelines. UDS artefacts and errors were classified into four categories according to the examination stages: Uroflowmetry, Cystometry, Pressure-flow study, and report interpretation. The quality of UDS traces and reports included in the study was evaluated under the guidance of three clinical experts with over 5 years of UDS and report interpretation experience. 
Additionally, using a self-designed demographic questionnaire, 300 questionnaires were distributed to the 64 UDS centers via the Chinese online survey platform "Wenjuanxing", and 288 valid questionnaires were collected to investigate the general information, health-related information, urodynamic work issues, and continuing education status of UDS operators. Demographic characteristics of 50 operators who provided UDS traces and reports were selected, and the correlation between their demographic characteristics and the occurrence rates of UDS artefacts and errors was analyzed. 
All statistical analyses and figure generation were performed using SPSS (version 27). Continuous variables were expressed as mean ± standard deviation, and categorical variables were reported as quantities and percentages. Descriptive statistics were used to illustrate the UDS quality and the demographic characteristics of UDS operators. Linear regression was employed for univariate analysis to analyze the correlation between the occurrence rates of UDS artefacts and errors and the demographic characteristics of corresponding UDS operators. A P value less than 0.05 was considered significant.

In the end, we collected 2600 UDS traces and reports from 50 UDS centers. A total of 2480 urodynamic traces and reports were included in the final analysis, with 120 excluded due to inability to identify or incomplete information. The average age of the included patients in the final analysis was 58.9 years, with 1370 (55.2%) being male and 1110 (44.8%) female. The most common diagnoses were bladder outlet obstruction (76.6%), detrusor overactivity (30.5%), and decreased bladder compliance (18.0%). In the comprehensive review, the top five artefacts or errors were as follows: no regular cough test 42.4% (IQR: 4.0, 76.0), no cough check after pressure-flow 40.8% (IQR: 0.0, 100.0), beyond the typical value range 27.3% (IQR: 3.5, 28.5), non-standard zero-setting 26.4% (IQR: 3.5, 20.0), and pressure drift 26.2% (IQR: 20.0, 30.0).
A total of 300 UDS operators participated in the survey, with 288 meeting all inclusion criteria. The average age of participating operators was 36±6.4 years, with 153 (53.1%) being male and 135 (46.9%) female. The survey included 145 (50.4%) doctors, 111 (38.5%) nurses, and 32 (11.1%) medical technicians. Health-related results showed that 48 participants (16.7%) had insomnia, 69 (24.0%) felt anxious, and 60 (20.8%) felt stressed about UDS work. Only 71 participants (24.6%) were full-time employees. They completed an average of 200 UDS examinations per year (IQR: 100, 400). 167 participants (58.0%) were dissatisfied with their current salary related to UDS, and 24 (8.3%) participants wanted to quit UDS-related work. The average duration of UDS training received by participants was 1.0 month (IQR: 0.4, 3.0), with only 121 participants (42.0%) obtaining UDS training certificates. Regression analysis results showed significant correlations between specific artefacts and errors and variables such as education level, professional title, hospital level, caffeine consumption, smoking, insomnia, stress related to UDS work, duration of UDS work per week (days), full-time employment status, annual number of UDS examinations, responsible for both examination and report interpretation, perception of UDS work prospects, duration of UDS training, UDS qualification certificate, and willingness to continue UDS training.

This study revealed the current quality status of UDS in China, identifying the most common artefacts and errors in the domestic UDS process, including no regular cough test, no cough check after pressure-flow, beyond the typical value range, non-standard zero-setting, and pressure drift. The findings underscore the need for targeted interventions to enhance compliance with UDS operating guidelines, thereby improving UDS quality.
A survey of UDS operators in this study found that the majority were doctors and nurses, with only a few being full-time UDS technicians. The survey revealed challenges faced by UDS operators, including stress, anxiety, insomnia, high workload, and lack of standardized training. Additionally, the survey results indicated that stress, insomnia, workload, and standardized training are influencing factors for artefacts and errors in UDS. These findings provide important insights for future targeted interventions to enhance UDS accuracy and improve patient diagnosis and treatment outcomes.

This study highlights the need for targeted interventions to improve compliance with urodynamic study (UDS) guidelines and support systems for UDS operators in China. By addressing common artefacts and errors and providing adequate training and resources, we can enhance the accuracy of UDS examinations and ensure better patient outcomes.

Rosier, P., et al., International Continence Society Good Urodynamic Practices and Terms 2016: Urodynamics, uroflowmetry, cystometry, and pressure-flow study. Neurourol Urodyn, 2017. 36(5): p. 1243-1260.

Continence 12S (2024) 101455
DOI: 10.1016/j.cont.2024.101455