Evidence map›Paper›PMID 42252647›Full record

ArticleInternational neurourology journal2026

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

Miho Song, Jong Hyun Yun, Hyun Young Lee, Seung Whan Doo, Ji Yeon Han, Ui Cheol Lee, Byeong Hun Jeong, Kisoo Lee, In Gab Jeong, Jae Heon Kim

Abstract read
In one paragraph

Article in International neurourology journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Miho SongDepartment of Urology, Soonchunhyang University College of Medicine, Seoul, Korea.
Jong Hyun YunDepartment of Urology, Soonchunhyang University College of Medicine, Seoul, Korea.
Hyun Young LeeDepartment of Urology, Soonchunhyang University College of Medicine, Seoul, Korea.
Seung Whan DooDepartment of Urology, Soonchunhyang University College of Medicine, Seoul, Korea.
Ji Yeon HanDepartment of Urology, Soonchunhyang University College of Medicine, Seoul, Korea.
Ui Cheol LeeHYGERA Networks Inc., Seoul, Korea.
Byeong Hun JeongHYGERA Networks Inc., Seoul, Korea.
Kisoo LeeDepartment of Urology, Dong-A University College of Medicine, Busan, Korea.
In Gab JeongDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. igjeong@amc.seoul.kr.
Jae Heon KimDepartment of Urology, Soonchunhyang University College of Medicine, Seoul, Korea. piacekjh@hanmail.net.

Funding

Korea Health Industry Development Institute 2460000767Ministry of Food and Drug Safety RS-2023-00255083Ministry of Health and Welfare HK23C005100Ministry of Science and ICTMinistry of Trade, Industry and Energy 2710002604Soonchunhyang University
6 · The paper itself

Abstract

purposeTo 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.

methodsA 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.

resultsSeven 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.

conclusionThis 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.

Indexed as

Assistive deviceElderlyFeasibility studyUrinary incontinenceUrine specimen agreementUser satisfaction

Identifiers

PMID42252647
PMCPMC13248951

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.