First in Human Subjects Testing of the UroMonitor: A Catheter-free Wireless Ambulatory Bladder Pressure Monitor

No AccessJournal of UrologyNew Technology and Techniques1 Jul 2023First in Human Subjects Testing of the UroMonitor: A Catheter-free Wireless Ambulatory Bladder Pressure MonitorThis article is commented on by the following:Editorial Comment Brendan T. Frainey, Steve J. A. Majerus, Samir Derisavifard, Kevin C. Lewis, Anna R. Williams, Brian M. Balog, Robert S. Butler, Howard B. Goldman, and Margot S. Damaser Brendan T. FraineyBrendan T. Frainey Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio , Steve J. A. MajerusSteve J. A. Majerus Advanced Platform Technology Center, Louis Stokes VA Medical Center, Cleveland, Ohio Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio , Samir DerisavifardSamir Derisavifard Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio , Kevin C. LewisKevin C. Lewis Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio , Anna R. WilliamsAnna R. Williams Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio , Brian M. BalogBrian M. Balog Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio , Robert S. ButlerRobert S. Butler Quantitative Health Sciences Department, Cleveland Clinic, Cleveland, Ohio , Howard B. GoldmanHoward B. Goldman Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio , and Margot S. DamaserMargot S. Damaser *Correspondence: Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, ND20, Cleveland, OH 44195 telephone: 216-444-1103; E-mail Address: [email protected] https://orcid.org/0000-0003-4743-9283 Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio Advanced Platform Technology Center, Louis Stokes VA Medical Center, Cleveland, Ohio Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio View All Author Informationhttps://doi.org/10.1097/JU.0000000000003451AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Urodynamics is the standard method of diagnosing bladder dysfunction, but involves catheters and retrograde bladder filling. With these artificial conditions, urodynamics cannot always reproduce patient complaints. We have developed a wireless, catheter-free intravesical pressure sensor, the UroMonitor, which enables catheter-free telemetric ambulatory bladder monitoring. The purpose of this study was twofold: to evaluate accuracy of UroMonitor pressure data, and assess safety and feasibility of use in humans. Materials and Methods: Eleven adult female patients undergoing urodynamics for overactive bladder symptoms were enrolled. After baseline urodynamics, the UroMonitor was transurethrally inserted into the bladder and position was confirmed cystoscopically. A second urodynamics was then performed with the UroMonitor simultaneously transmitting bladder pressure. Following removal of urodynamics catheters, the UroMonitor transmitted bladder pressure during ambulation and voiding in private. Visual analogue pain scales (0-5) were used to assess patient discomfort. Results: The UroMonitor did not significantly alter capacity, sensation, or flow during urodynamics. The UroMonitor was also easily inserted and removed in all subjects. The UroMonitor reproduced bladder pressure, capturing 98% (85/87) of voiding and nonvoiding urodynamic events. All subjects voided with only the UroMonitor in place with low post-void residual volume. Median ambulatory pain score with the UroMonitor was rated 0 (0-2). There were no post-procedural infections or changes to voiding behavior. Conclusions: The UroMonitor is the first device to enable catheter-free telemetric ambulatory bladder pressure monitoring in humans. The UroMonitor appears safe and well tolerated, does not impede lower urinary tract function, and can reliably identify bladder events compared to urodynamics. REFERENCES 1. . Incontinence. In: , eds. Incontinence, 6th ed. Vol 1. International Continence Society; 2017:599-644. Google Scholar 2. . Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn. 2002; 21(3):261-274. 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Neurourol Urodyn. 2003; 22(2):130-137. Crossref, Medline, Google Scholar 26. . A conductance-based sensor to estimate bladder volume in felines. Annu Int Conf IEEE Eng Med Biol Soc. 2018; 2018:1592-1595. Medline, Google Scholar 27. . Feasibility of fluid volume conductance to assess bladder volume. Neurourol Urodyn. 2008; 27(6):525-531. Crossref, Medline, Google Scholar Support: This research was supported in part by funds from the Research Program Committee of the Cleveland Clinic, Urology Care Foundation, and the Department of Veterans Affairs. Conflict of Interest: Drs Majerus and Damaser have intellectual property in the UroMonitor technology, which has been licensed to a company for commercialization. Drs Majerus and Damaser were not involved with recruitment of subjects for this study. Dr Goldman is an investor in the company licensing the UroMonitor technology. Data collection and analysis for this study were completed prior to the license date and commencement of these competing interests. Ethics Statement: This study received Institutional Review Board approval (IRB No. 19-072). Author Contributions: Conceptualization: BTF, SJAM, SD, HBG, MSD; Designed the UroMonitor system: SJAM, MSD; Performed the experiment: BTF, SJAM, SD, ARW, HBG; Patient recruitment: BTF, SD, HBG; Experimental design: SD, HBG, MSD, SJAM; Performed urodynamics: ARW; Device assembly: BMB, SJAM; Data collection: SJAM, BTF, KCL, ARW; Data analysis: SJAM, MSD, SD, RSB; Performed statistical analysis: RSB; Interpretation of Urodynamics and UroMonitor data: BTF, SD, HBG, MSD, RSB, SJAM, KCL; Graphing of results: SJAM, KCL, BTF, BMB, RSB; Supervision: HBG, MSD; Writing—original draft: BTF, SJAM, SD, MSD; Writing—review and editing: BTF, SJAM, SD, KCL, ARW, BMB, RSB, HBG, MSD; Approved final version of the manuscript: BTF, SJAM, SD, KCL, ARW, BMB, RSB, HBG, MSD. Data and Materials Availability: Individual patient data that underlie the results reported in this article, after deidentification, can be made available upon request. Figures 2-4 have associated raw data. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited bySiemens D (2023) This Month in Adult UrologyJournal of Urology, VOL. 210, NO. 1, (1-2), Online publication date: 1-Jul-2023.Frainey B, Majerus S, Derisavifard S, Lewis K, Williams A, Balog B, Butler R, Goldman H and Damaser M (2023) Reply by AuthorsJournal of Urology, VOL. 210, NO. 1, (195-195), Online publication date: 1-Jul-2023.Daneshgari F (2023) Editorial CommentJournal of Urology, VOL. 210, NO. 1, (194-194), Online publication date: 1-Jul-2023.Related articlesJournal of Urology9 Jun 2023Editorial Comment Volume 210Issue 1July 2023Page: 186-195Supplementary Materials Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.Keywordsurethraurodynamicsfemaleurinary cathetersACKNOWLEDGMENTSWe thank Dr Sandip Vasavada for his work recruiting patients, and Therese Bahniuk, RN, and Tara Amero-Powell, BSN, RN, for their work performing urodynamics.MetricsAuthor Information Brendan T. Frainey Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author Steve J. A. Majerus Advanced Platform Technology Center, Louis Stokes VA Medical Center, Cleveland, Ohio Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author Samir Derisavifard Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author Kevin C. Lewis Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author Anna R. Williams Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author Brian M. Balog Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author Robert S. Butler Quantitative Health Sciences Department, Cleveland Clinic, Cleveland, Ohio More articles by this author Howard B. Goldman Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author Margot S. Damaser Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio Advanced Platform Technology Center, Louis Stokes VA Medical Center, Cleveland, Ohio Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio *Correspondence: Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, ND20, Cleveland, OH 44195 telephone: 216-444-1103; E-mail Address: [email protected] More articles by this author Expand All Support: This research was supported in part by funds from the Research Program Committee of the Cleveland Clinic, Urology Care Foundation, and the Department of Veterans Affairs. Conflict of Interest: Drs Majerus and Damaser have intellectual property in the UroMonitor technology, which has been licensed to a company for commercialization. Drs Majerus and Damaser were not involved with recruitment of subjects for this study. Dr Goldman is an investor in the company licensing the UroMonitor technology. Data collection and analysis for this study were completed prior to the license date and commencement of these competing interests. Ethics Statement: This study received Institutional Review Board approval (IRB No. 19-072). Author Contributions: Conceptualization: BTF, SJAM, SD, HBG, MSD; Designed the UroMonitor system: SJAM, MSD; Performed the experiment: BTF, SJAM, SD, ARW, HBG; Patient recruitment: BTF, SD, HBG; Experimental design: SD, HBG, MSD, SJAM; Performed urodynamics: ARW; Device assembly: BMB, SJAM; Data collection: SJAM, BTF, KCL, ARW; Data analysis: SJAM, MSD, SD, RSB; Performed statistical analysis: RSB; Interpretation of Urodynamics and UroMonitor data: BTF, SD, HBG, MSD, RSB, SJAM, KCL; Graphing of results: SJAM, KCL, BTF, BMB, RSB; Supervision: HBG, MSD; Writing—original draft: BTF, SJAM, SD, MSD; Writing—review and editing: BTF, SJAM, SD, KCL, ARW, BMB, RSB, HBG, MSD; Approved final version of the manuscript: BTF, SJAM, SD, KCL, ARW, BMB, RSB, HBG, MSD. Data and Materials Availability: Individual patient data that underlie the results reported in this article, after deidentification, can be made available upon request. Figures 2-4 have associated raw data. 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