Usability, Safety, and Diagnostic Reliability of an Automated Urinary Suction Device in Diaper-Dependent Older Adults

다국어 초록 (Multilingual Abstract)

Purpose: To evaluate the pilot clinical feasibility of an automatic urinary suction device in mobility-limited older adults, focusing on usability, functional performance, and perceived safety, and a secondary exploratory assessment of agreement between device-collected and reference urine specimens.
Methods: A 2-cohort clinical evaluation was conducted. The primary usability cohort assessed functional performance, perceived safety, and user satisfaction using structured 5-point Likert-scale questionnaires administered before and after device implementation. A secondary diagnostic cohort compared paired urine samples obtained using the automated suction device and standard-of-care reference urine collection methods to assess bacterial detection agreement, species concordance, and urine pH agreement. Paired statistical analyses with nonparametric sensitivity testing were used for usability outcomes, and diagnostic metrics were calculated with Wilson confidence intervals and Bland-Altman analysis.
Results: Seven participants completed paired usability assessments. Significant improvements were observed in operation and functionality (2.97±0.52 vs. 3.83±0.18, P=0.007) and ease of use (2.14±0.48 vs. 3.71±0.39, P=0.001), suggesting improved practicality of urinary management. Scores in the infection/skin complication domain decreased significantly. Product safety and overall satisfaction showed favorable but nonsignificant trends. In a secondary exploratory diagnostic analysis of 12 paired urine samples, bacterial detection agreement was acceptable at the presence/absence level (sensitivity 80.0%, specificity 100.0%, accuracy 91.7%), whereas species-level concordance was limited (40.0%), indicating restricted microbiologic reliability. Urine pH showed close numerical agreement. However, these findings should be interpreted cautiously, as key preanalytical variables were not controlled, and therefore should be regarded as exploratory rather than confirmatory.
Conclusions: This pilot study suggests that the automated urinary suction device may improve usability and functional handling in mobility-limited older adults. Skin-related findings remain preliminary, and the diagnostic applicability of device-collected urine should be interpreted cautiously pending further validation.