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 for adult patients in March 2025 and an abdominal-sensor addition in April 2026.[1][2] The latter permits multichannel pressure recording and calculation of detrusor pressure; describing every Glean configuration as vesical-pressure-only is now outdated.[1][2]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. The cleared intended environment is a clinic, including ambulatory activity during testing; it does not include 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. |
| 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 specify a bladder-sensor diameter of less than 5.35 mm (16 Fr), an abdominal-sensor maximum diameter of 17.5 mm for the 2026 configuration, silicone sensor construction, a pressure range of 0 to 320 cm H2O, a minimum 20 Hz sampling rate for that configuration and a clinic environment of use.[1][2] In MUSE, the 15 Fr bladder sensor had an 18 Fr coudé tip and was deployed through a 20 Fr insertion tool.[3] The bladder sensor has a removal string that hangs out of the urethra. It can stay in the bladder for the whole monitoring period.[1]
The sequence in the MUSE study was as follows:
- The sensor is inserted transurethrally with the insertion tool. Median insertion time was 33.6 seconds (range 12.3 to 256).
- The patient drinks and moves about while the sensor records pressure with physiologic filling.
- The patient voids with the sensor in place. All 32 participants with an inserted sensor voided.
- The sensor is removed by its string. Median removal time was 5.7 seconds (range 0.8 to 22.2).
These figures come from the MUSE study and the FDA summary.[3][1]
Use the current commercial instructions and local training for selection, insertion, retrieval, examination duration and device-specific precautions.[1][2]
Clinical Evidence
MUSE — Feasibility and Short-Term Safety
The original single-channel Glean system was evaluated in the prospective, single-arm, multicenter MUSE study of 38 adults with lower urinary tract dysfunction.[1][3] The study excluded active UTI, pregnancy or breastfeeding, and inability to tolerate 18 Fr catheterization.[3] Each participant had conventional urodynamics first, then Glean monitoring. Insertion was attempted in 33 and succeeded in 32 (97.0%).[3] The one failed insertion was in a man with a bladder neck contracture. All 32 participants with an inserted sensor voided, and vesical pressure was recorded in all 32.[3][1] About half of the 32 were men (53.1%).[3][1]
| Parameter | Result |
|---|---|
| Insertion success | 32 of 33 attempts (97.0%) |
| Median insertion time | 33.6 s (range 12.3 to 256) |
| Median removal time | 5.7 s (range 0.8 to 22.2) |
| Voided with sensor in place | 32 of 32 |
| Adverse events | 14 in 12 participants; 7 attributed to Glean |
| Serious adverse events | 0 |
The FDA summary describes the device-related events as mild hematuria (four), genitourinary discomfort (two) and dysuria (one). All resolved without intervention by follow-up at 7 to 14 days. Clinicians rated 81% of insertions and 97% of removals easy or very easy. Patients reported more discomfort with Glean placement than with conventional catheters, although 64.5% preferred Glean for future testing. Glean was always used after conventional testing, which may have raised its discomfort scores.[1]
Among 32 MUSE participants, clinicians confirmed the initial diagnosis after Glean in 8 and coded 21 as changed or refined; the latter group included 2 inconclusive studies and 7 without confirmed incontinence because leak annotations were missing. Conventional testing confirmed 24 diagnoses and changed or refined 8.[1] There was no comparison against an independent diagnostic standard.[1] Incontinence was not accurately diagnosed on Glean tracings because leak annotations were missing.[1]
Bench Performance
Hamson's 2026 study compared 30 Glean sensors and 30 Laborie Goby air-charged catheters in a bench-top human bladder model with stepped, sinusoidal and ramping pressure simulations. The authors were employees of the manufacturer, Bright Uro.[4]
| Metric | Glean | Laborie Goby air-charged catheter |
|---|---|---|
| Rise time | 0.104 s | 0.172 s |
| Fall time | 0.111 s | 0.264 s |
| Bandwidth (5 Hz maximum tested) | 4.978 Hz | 2.250 Hz |
| Mean maximum error (hPa) | 6.882 | 21.549 |
All differences had p < 0.001, and both devices were linear. Hamson's bench comparison included one conventional UDS system and no patient outcomes.[4]
UroMonitor Research Predecessor
Frainey's 2023 first-in-human study in 11 women with OAB symptoms detected 85 of 87 voiding and nonvoiding urodynamic events (98%).[5] All 11 women voided with the UroMonitor prototype in place, but two expelled a device during voiding and received a replacement. Median ambulatory pain was 0 on a 0-to-5 scale.[5] Gross's subsequent study included 10 women with multiple sclerosis and neurogenic bladder using a research UroMonitor. It captured 98% of events, including all detrusor overactivity.[6] Both are small prototype studies, distinct from validation of every current Glean configuration.[5][6]
In Gross's study, post-void residual after conventional testing was 160 ± 179 mL, compared with 19 ± 18 mL after ambulation with the device alone (p = 0.01). However, the fixed test order, privacy, filling conditions and residual-measurement methods differed. 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.[3][4][7]
Proposed uses include urgency episodes that do not reproduce in a laboratory test, neurogenic bladder in which a urethral catheter prevents voiding, and incontinence after prostatectomy or radiation under everyday conditions. Published prototype data exist only for OAB symptoms and MS-related neurogenic bladder, including borderline obstruction and inability to void while observed.[5][6][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;40(9):997-1005. 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