{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T19:47:00Z","timestamp":1790192820587,"version":"4.1.0"},"reference-count":9,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,2,10]],"date-time":"2025-02-10T00:00:00Z","timestamp":1739145600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Urinary incontinence (UI) is a very common hygiene and health problem in adults which has an enormous impact on quality of life (QoL). Noninvasive treatment options are the first line of treatment. It would be beneficial to know when the bladder reaches its maximum capacity, to enable to prompt going to the bathroom on time and thereby potentially prevent an UI event. Recently, a wearable bladder sensor was developed, the TENA SmartCare Bladder Sensor (Bladder Sensor), which is intended to support children (\u2009\u2265\u20096 years) and adults (BMI\u2009\u2264\u200925\u2009kg\/m<jats:sup>2<\/jats:sup>). The Bladder Sensor tracks the bladder filling status and notifies the user when it is time to go to the bathroom by a vibration of the device and\/or a notification in an app on a mobile device (e.g., smartphone and\/or Apple Watch\u00ae). The primary objective of this first pivotal study was to demonstrate that the Bladder Sensor can detect the bladder before urination among adult intended users. The secondary objectives were to collect real\u2010life data to evaluate performance, safety, usability, and subject satisfaction with the device as well as impact on QoL. The primary hypothesis was to evaluate if the median bladder detection rate in the evaluated population is greater than the threshold of 85% (H0: \u2264\u20090.85, H1: &gt;\u20090.85, <jats:italic>p<\/jats:italic>\u2010value\u2009&lt;\u20090.05).<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients &amp; Methods<\/jats:title><jats:p>Adults (\u2009\u2265\u200918 years) suffering from UI during day and\/or night tested the Bladder Sensor independently at home for 1 week. Device performance, safety, usability, user satisfaction and self\u2010reported disease specific information, and QoL were assessed at pre\u2010defined times. Intra\u2010individual results were compared. Any episodes of urination and\/or urine loss were documented by subjects in a paper diary. Raw data of the Bladder Sensor was analyzed to evaluate the bladder detection rate and full bladder notification rate(s).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>30 adults (female\/male: 67%\/33%; median age: 53 years (Interquartile range (IQR) 32\u201361 years); median BMI of 22.6\u2009kg\/m<jats:sup>2<\/jats:sup> (IQR 20.7\u201323.8\u2009kg\/m<jats:sup>2<\/jats:sup>)) completed the study testing the Bladder Sensor at home for 6.9 days on average. The median bladder detection rate was 89.8% (IQR 82.6\u201395.3%) in a sample without statistically and clinically identified outliers (<jats:italic>n<\/jats:italic>\u2009=\u200928). The null hypothesis was rejected among those (<jats:italic>z<\/jats:italic>\u2009=\u200969, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.05). The median actual full bladder notification rate was 63.1% (IQR 50.0\u201371.4%), and the median perceived full bladder notification rate was 94.4% (IQR 87.0\u2013105.6%). The device showed to have a positive effect on subjects\u2019 UI problems (e.g., 67% reduced number of unwanted leakages) and QoL.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>It was demonstrated that the Bladder Sensor can detect the bladder under real\u2010life conditions among its intended users and can support in the prevention of UI. This seemed dependent on anatomical limitations (e.g., BMI and body shape), bladder volume (low bladder detection rate &lt;\u2009100\u2009mL), and\/or proper fixation. The device had a positive effect on the subject's urinary incontinence, their Qo,L and overall well\u2010being while testing it for 1 week. It is assumed that this effect will be strengthened when users incorporate the use of the device into their daily life. Long\u2010term benefits of the Bladder Sensor as an adjunct tool in continence care management needs to be investigated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>Registration number is NL81246.000.22.<\/jats:p><\/jats:sec>","DOI":"10.1002\/nau.70009","type":"journal-article","created":{"date-parts":[[2025,2,11]],"date-time":"2025-02-11T06:41:10Z","timestamp":1739256070000},"page":"795-803","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A Bladder Sensor for Adults With Urinary Incontinence"],"prefix":"10.1002","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-7729-8273","authenticated-orcid":false,"given":"Filine","family":"van den Bosch","sequence":"first","affiliation":[{"name":"Novioscan B.V.\u2014An Essity company Transistorweg 5 Nijmegen 6534AT The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"van Leuteren","sequence":"additional","affiliation":[{"name":"Novioscan B.V.\u2014An Essity company Transistorweg 5 Nijmegen 6534AT The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Tobisch","sequence":"additional","affiliation":[{"name":"BSN medical GmbH\u2014An Essity company Sch\u00fctzenstra\u00dfe 1\u20103 Hamburg 22761 Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diederick","family":"Duijvesz","sequence":"additional","affiliation":[{"name":"Department of Urology Canisius Wilhelmina Hospital Weg door Jonkerbos 100 Nijmegen 6532SZ The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,2,10]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urology.2009.11.078"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpurol.2011.12.005"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.afju.2013.10.001"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.3390\/s23052758"},{"key":"e_1_2_11_6_1","unstructured":"L.Cardozo E.Rovner A.Wagg A.Wein andP.Abrams INCONTINENCE \u2013 7thedition2023 ISBN: 978\u20100\u20109569607\u20104\u20100."},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpurol.2018.07.018"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpurol.2019.04.006"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpurol.2020.01.012"},{"key":"e_1_2_11_10_1","doi-asserted-by":"crossref","unstructured":"P. G.vanLeuteren(2020). Development validation and implementation of a wearable ultrasonic bladder sensor for pediatric applications. [PhD Thesis \u2013 Research UT graduation UT University of Twente]. University of Twente https:\/\/doi.org\/10.3990\/1.9789036550727.","DOI":"10.3990\/1.9789036550727"}],"container-title":["Neurourology and Urodynamics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/nau.70009","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,24]],"date-time":"2025-04-24T03:18:28Z","timestamp":1745464708000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/nau.70009"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,10]]},"references-count":9,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1002\/nau.70009"],"URL":"https:\/\/doi.org\/10.1002\/nau.70009","archive":["Portico"],"relation":{},"ISSN":["0733-2467","1520-6777"],"issn-type":[{"value":"0733-2467","type":"print"},{"value":"1520-6777","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,10]]},"assertion":[{"value":"2024-09-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-10","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}