Zeng Xiao, Shen Hong, Jin Tao, Luo Deyi
Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.
Bladder (San Franc). 2025 Mar 27;12(2):e21200040. doi: 10.14440/bladder.2024.0073. eCollection 2025.
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.
This study explored the application of SPC to analyze the typical value ranges (TVR) of urodynamic measurements.
A total of 84 urodynamic traces that met all inclusion criteria were included for analysis. We recorded the TVR for initial intravesical pressure (P), initial abdominal pressure (P), and initial detrusor pressure (P) 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.
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 was 34.81 ± 10.78 cmHO, P 30.92 ± 11.14 cmHO, and P 4.20 ± 3.73 cmHO. 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.
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.
尿动力学检查（UDS）对于评估下尿路功能至关重要，但质量控制方法仍然有限。统计过程控制（SPC）最初是在制造业中开发的一种工具，在医疗保健领域已显示出改善质量和减少变异性的前景。
本研究探讨了SPC在分析尿动力学测量典型值范围（TVR）中的应用。
共纳入84条符合所有纳入标准的尿动力学记录进行分析。我们记录了每条纳入的UDS记录的初始膀胱内压（P）、初始腹压（P）和初始逼尿肌压（P）的TVR。然后将这些数据与标准TVR进行比较。此外，我们使用SPC的X-bar和S控制图进行过程性能分析。
该研究包括20名女性和64名男性，平均年龄为58.02±16.09岁。参与者中，32人被诊断为神经源性膀胱功能障碍，52人被诊断为非神经源性膀胱功能障碍。初始P的平均TVR为34.81±10.78 cmH₂O，P为30.92±11.14 cmH₂O，P为4.20±3.73 cmH₂O。我们使用散点图进一步分析了数据。在X-bar控制图中，控制限（CL）为22.48，上控制限（UCL）为32.04，下控制限（LCL）为12.92。在S控制图中，CL为15.78，UCL为22.57，LCL为8.9。在X-bar控制图中有2例超过UCL，在S控制图中有1例超过UCL。
SPC在UDS质量评估中的临床价值在先前的研究中已得到证实。在本研究中，我们初步验证了SPC用于连续变量数据，如UDS参数的TVR 的情况。本研究结果需要在更大样本量、多中心和前瞻性研究中进一步验证。
