Portable Ultrasound Bladder Volume Measurement Over Entire Volume Range Using a Deep Learning Artificial Intelligence Model in a Selected Cohort: A Proof of Principle Study.
Authors
Affiliations (4)
Affiliations (4)
- Department of Medical Device Development, Seoul National University College of Medicine, Seoul, Republic of Korea.
- Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
- Department of Obstetrics and Gynecology, Dankook University College of Medicine, Cheonan, Republic of Korea.
- Department of Urology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Abstract
We aimed to prospectively investigate whether bladder volume measured using deep learning artificial intelligence (AI) algorithms (AI-BV) is more accurate than that measured using conventional methods (C-BV) if using a portable ultrasound bladder scanner (PUBS). Patients who underwent filling cystometry because of lower urinary tract symptoms between January 2021 and July 2022 were enrolled. Every time the bladder was filled serially with normal saline from 0 mL to maximum cystometric capacity in 50 mL increments, C-BV was measured using PUBS. Ultrasound images obtained during this process were manually annotated to define the bladder contour, which was used to build a deep learning AI model. The true bladder volume (T-BV) for each bladder volume range was compared with C-BV and AI-BV for analysis. We enrolled 250 patients (213 men and 37 women), and a deep learning AI model was established using 1912 bladder images. There was a significant difference between C-BV (205.5 ± 170.8 mL) and T-BV (190.5 ± 165.7 mL) (p = 0.001), but no significant difference between AI-BV (197.0 ± 161.1 mL) and T-BV (190.5 ± 165.7 mL) (p = 0.081). In bladder volume ranges of 101-150, 151-200, and 201-300 mL, there were significant differences in the percentage of volume differences between [C-BV and T-BV] and [AI-BV and T-BV] (p < 0.05), but no significant difference if converted to absolute values (p > 0.05). C-BV (R<sup>2</sup> = 0.91, p < 0.001) and AI-BV (R<sup>2</sup> = 0.90, p < 0.001) were highly correlated with T-BV. The mean difference between AI-BV and T-BV (6.5 ± 50.4) was significantly smaller than that between C-BV and T-BV (15.0 ± 50.9) (p = 0.001). Following image pre-processing, deep learning AI-BV more accurately estimated true BV than conventional methods in this selected cohort on internal validation. Determination of the clinical relevance of these findings and performance in external cohorts requires further study. The clinical trial was conducted using an approved product for its approved indication, so approval from the Ministry of Food and Drug Safety (MFDS) was not required. Therefore, there is no clinical trial registration number.