Evidence map›Paper›PMID 37293725›Full record

ArticleThe Journal of urology2023

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

Brendan T Frainey, Steve J A Majerus, Samir Derisavifard, Kevin C Lewis, Anna R Williams, Brian M Balog, Robert S Butler, Howard B Goldman, Margot S Damaser

2 registry-linked trialsOpen access · greenAbstract read
In one paragraph

Article in The Journal of urology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
8.0field-weighted citation impact, top 2% of its field
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.

NCT05694793 naactive not recruitingnot on this mapstarted 2025, after this paper: background citation

Trial for Reliability of Urodynamics SysTem

TypeinterventionalSponsorBright UroRan2025 to 2026Enrolled28ConditionsUrologic Diseases, UrodynamicsArmsGlean Urodynamics System
NCT05959655 nacompletednot on this map

Modern Urodynamics System Efficacy (MUSE) Study

TypeinterventionalSponsorBright UroRan2023 to 2024Enrolled38ConditionsUrologic Diseases, UrodynamicsArmsGlean Urodynamics System
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 27 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Artifacts in Urodynamic Studies: A Narrative Review.Neurourology and urodynamics · 2025
    Review
  9. Article
  10. Automated Point-of-Care Bladder Pressure and Volume Measurement Device for Urodynamic Monitoring.Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference · 2025
    Article
  11. Review
  12. Article
  13. Review
  14. Automated closed-loop stimulation to inhibit neurogenic bladder overactivity.Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine · 2024
    Article
  15. Optimization of activity-driven event detection for long-term ambulatory urodynamics.Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine · 2024
    Article
  16. A wireless, implantable bioelectronic system for monitoring urinary bladder function following surgical recovery.Proceedings of the National Academy of Sciences of the United States of America · 2024
    Article
  17. Review
  18. Review
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

9 authors at 2 institutions in 1 country.

Brendan T FraineyGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio.
Steve J A MajerusAdvanced Platform Technology Center, Louis Stokes VA Medical Center, Cleveland, Ohio.
Samir DerisavifardGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio.
Kevin C LewisGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio.
Anna R WilliamsGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio.
Brian M BalogDepartment of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
Robert S ButlerQuantitative Health Sciences Department, Cleveland Clinic, Cleveland, Ohio.
Howard B GoldmanGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio.
Margot S DamaserGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio.ORCID 0000-0003-4743-9283
Cleveland Clinic · USCleveland Clinic Lerner College of Medicine · US

Funding

RRD VA I01 RX003687
6 · The paper itself

Abstract

purposeUrodynamics 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

methodsEleven 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.

resultsThe 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.

conclusionsThe 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.

Indexed as

Urinary BladderUrinationAdultFemaleHumansResearch SubjectsUrinary CathetersUrodynamicsfemaleurethraurinary cathetersurodynamics

Identifiers

PMID37293725
PMCPMC11675714
OpenAlexW4379967694

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.