Quality review of typical value ranges in urodynamic measurements using statistical process control: A single-center retrospective study.

Background: Urodynamic study (UDS) is essential for assessing lower urinary tract function, but quality control methods remain limited. Statistical process control (SPC), a tool originally developed in manufacturing, has shown promise in healthcare for improving quality and reducing variability.

Objective: This study explored the application of SPC to analyze the typical value ranges (TVR) of urodynamic measurements.

Methods: A total of 84 urodynamic traces that met all inclusion criteria were included for analysis. We recorded the TVR for initial intravesical pressure (P_ves), initial abdominal pressure (P_abd), and initial detrusor pressure (P_det) from each enrolled UDS trace. These data were then compared with the standard TVR. In addition, we used the X-bar and S control charts of SPC for process performance analysis.

Results: The study included 20 females and 64 males, with an average age of 58.02 ± 16.09 years. Of the participants, 32 were diagnosed with neurogenic bladder dysfunction, and 52 were diagnosed with non-neurogenic bladder dysfunction. The average TVR for initial P_ves was 34.81 ± 10.78 cmH₂O, P_abd 30.92 ± 11.14 cmH₂O, and P_det 4.20 ± 3.73 cmH₂O. We further analyzed the data using scatter plots. In the X-bar control chart, the control limit (CL) was 22.48, the upper CL (UCL) was 32.04, and the lower CL (LCL) was 12.92. In the S control chart, the CL was 15.78, the UCL was 22.57, and the LCL was 8.9. Two cases exceeded the UCL in the X-bar control chart, and one case exceeded the UCL in the S control chart.

Conclusion: The clinical value of SPC in the quality review of UDS has been confirmed in previous studies. In this study, we preliminarily verified the use of SPC for continuous variable data, such as the TVR of UDS parameters. The results of this study need to be further validated in a larger sample size, multi-center, and prospective study.