Clinical needs assessment for non-invasive intraoperative bladder volume monitoring devices: a cross-sectional study based on the Kano model

无创术中膀胱容量监测设备的临床需求评估:基于 Kano 模型的横断面研究

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Abstract

Intraoperative urine output is a key indicator of fluid balance and renal function. With the rise of enhanced recovery after surgery (ERAS) protocols, there is a growing demand for non-invasive bladder monitoring alternatives to traditional catheterization, which poses risks such as infection and urethral injury. This study aimed to identify user-centered requirements for a non-invasive intraoperative bladder volume monitoring device using the Kano model. A cross-sectional survey was conducted among 388 surgical professionals, including anesthesiologists, surgeons, and nurses from tertiary hospitals. A Kano-based questionnaire evaluated 24 features related to device function, operation, and design. Image-assisted prototypes were used to enhance clarity. Features were classified using the Kano model and analyzed with Better-Worse coefficients. Seven features, including measurement accuracy, safety, and real-time monitoring, were identified as must-be attributes. Eight one-dimensional attributes, such as urine volume alarms and ergonomic design, positively influenced user satisfaction. Attractive features like trend analysis and affordable pricing showed high satisfaction potential. Role-specific preferences were observed across professional groups. This is the first Kano-based study assessing intraoperative non-invasive urine monitoring needs. Findings offer actionable insights for developing ERAS-compatible, user-centered monitoring technologies tailored to multidisciplinary workflows.

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