Glean Urodynamics System
Glean (Bright Uro) records bladder pressure during natural filling without leaving a catheter across the urethra during the recording. The FDA cleared the initial system in March 2025 and an abdominal-sensor addition in April 2026. The latter permits multichannel pressure recording and calculation of detrusor pressure; describing every Glean configuration as vesical-pressure-only is now outdated. Clearance establishes a device indication, not superior diagnostic accuracy or better treatment outcomes.[1][2]
For deciding whether testing will change management, interpreting traces and selecting conventional versus ambulatory studies, see Urodynamics.
Current System and Workflow
The 2026 FDA summary describes four physical components: a bladder sensor, an abdominal sensor, a bladder-sensor insertion tool and a uroflow device, with clinician, patient-diary and web applications. The bladder sensor is inserted transurethrally; the abdominal sensor is placed in the anorectal canal and has a removal string. Neither “wireless” nor “catheter-free” means no insertion procedure or no rectal instrumentation.[2]
The sensors store pressure data during the examination and transmit it after removal. Uroflow measures voided volume and flow, which are transmitted after a void. This differs from the real-time external receiver used in research UroMonitor prototypes; their specifications should not be substituted for the commercial system. The cleared intended environment is a clinic, including ambulatory activity during testing, rather than unrestricted multi-day home monitoring.[1][2]
| Question | Device-specific distinction |
|---|---|
| What pressure is available? | A bladder sensor alone measures vesical pressure. With a valid, synchronized abdominal-pressure signal, the multichannel configuration can calculate detrusor pressure: Pdet = Pves − Pabd. |
| Does it continuously measure bladder volume? | No. Uroflow measures the urine passed during voiding; this is not continuous intravesical volume monitoring or a complete compliance assessment. |
| Can the patient void with the sensor present? | This was feasible in the small clinical study; successful insertion and voiding are not guaranteed for every patient. |
| Does physiologic filling eliminate artifact? | No. Movement, signal quality, event timing and symptom annotations still require review. |
| Does clearance settle clinical utility? | No. The FDA summaries do not establish replacement of all conventional UDS components, clinical-outcome superiority or performance in every complex reconstructive population. |
Use the current commercial instructions and local training for selection, insertion, retrieval, examination duration and device-specific precautions. A draft manual or an earlier prototype paper should not supply the current handling or MRI instructions.[1][2]
Clinical Evidence
MUSE — Feasibility and Short-Term Safety
The prospective, single-arm MUSE study enrolled 38 adults. Insertion was attempted in 33 and succeeded in 32; all 32 participants with an inserted sensor voided. The successful-insertion group included 17 men, so this study was not predominantly female. The FDA summary reports 14 adverse events in 12 participants, including seven device-related events, with no serious adverse event during the short follow-up. Placement was not uniformly more comfortable than conventional testing. These findings support feasibility, not a guarantee of painless insertion, normal emptying or rare-event safety.[3][1]
Interpretive changes were reported after monitoring, but there was no randomized comparison against an independent diagnostic standard. Missing incontinence annotations and missing interpretations also limit conclusions about diagnostic accuracy. “Changed diagnosis” is not by itself proof of a more accurate diagnosis or improved treatment.[1]
Bench Performance
Hamson's 2026 study compared 30 Glean sensors and 30 Laborie Goby air-charged catheters in simulated pressure conditions. Glean had faster dynamic responses and lower error in this setup. This was a bench comparison, not a clinical diagnostic trial, and cannot establish superiority over every conventional UDS system or better patient outcomes.[4]
UroMonitor Research Predecessor
Frainey's 2023 first-in-human study in 11 women with OAB detected 85 of 87 urodynamic events. Gross's subsequent study included 10 women with multiple sclerosis using a research UroMonitor. Both are small prototype studies, distinct from validation of every current Glean configuration.[5][6]
In Gross's study, mean residual volume was lower during the catheter-free ambulatory phase than during conventional testing. However, the fixed test order, privacy, filling conditions and residual-measurement methods differed. The result does not isolate the urethral catheter as the sole cause, and it does not establish normal voiding in all patients with neurogenic dysfunction. The prototype measured vesical pressure without an abdominal signal or continuous volume measurement.[6]
Practical Interpretation
Natural filling and freedom to move may help investigate symptoms that a brief laboratory test fails to reproduce. Their value depends on the specific unanswered question and usable synchronized pressure, flow and symptom data. The existing evidence does not support a universal Glean-over-conventional-UDS ranking for comfort, pressure accuracy, symptom reproduction or preoperative decision-making.[3][4][7]
Other published wireless bladder-monitoring systems include UroMOCA, WiCa and the Bladder Pill. Their animal or bench work should not be described as established clinical alternatives or evidence that the current Glean system monitors both pressure and volume continuously.[8][9][10]
Videos
References
1. FDA. Glean Urodynamics System, K243052. March 24, 2025. Clearance letter, indications and 510(k) summary, including the MUSE study. FDA document.
2. FDA. Glean Urodynamics System, K253537. April 16, 2026. Clearance letter, indications and 510(k) summary for the addition of an abdominal-pressure sensor. FDA document.
3. Kim J, Xavier K, Cannon-Smith T, et al. The Feasibility and Safety of the Glean Urodynamics System: The Modern Urodynamics System Efficacy Study. Journal of Endourology. 2025;39(6):625-634. doi:10.1089/end.2025.0270
4. Hamson M, Maahs T, Poulsen A, et al. Comparative Pressure Measurement Performance of the Glean Urodynamics System — A Novel Wireless and Catheter-Free Urodynamics Device. Journal of Endourology. 2026. doi:10.1177/08927790261430997
5. Frainey BT, Majerus SJA, Derisavifard S, et al. First in Human Subjects Testing of the UroMonitor: A Catheter-Free Wireless Ambulatory Bladder Pressure Monitor. The Journal of Urology. 2023;210(1):186-195. doi:10.1097/JU.0000000000003451
6. Gross MD, Frainey BT, Lyon ME, et al. Validation of a Wireless Catheter-Free Ambulatory Urodynamics Device in Women With Neurogenic Bladder. Neurourology and Urodynamics. 2026;45(1):96-104. doi:10.1002/nau.70172
7. Abelson B, Majerus S, Sun D, et al. Ambulatory Urodynamic Monitoring: State of the Art and Future Directions. Nature Reviews Urology. 2019;16(5):291-301. doi:10.1038/s41585-019-0175-5
8. Majerus SJA, Hanzlicek B, Hacohen Y, et al. Wireless and Catheter-Free Bladder Pressure and Volume Sensor. IEEE Sensors Journal. 2024;24(6):7308-7316. doi:10.1109/jsen.2023.3267749
9. Wille S, Schumacher P, Paas J, et al. Catheterless Long-Term Ambulatory Urodynamic Measurement Using a Novel Three-Device System. PLoS One. 2014;9(5):e96280. doi:10.1371/journal.pone.0096280
10. Soebadi MA, Bakula M, Hakim L, Puers R, De Ridder D. Wireless Intravesical Device for Real-Time Bladder Pressure Measurement: Study of Consecutive Voiding in Awake Minipigs. PLoS One. 2019;14(12):e0225821. doi:10.1371/journal.pone.0225821