Glean™ Urodynamics System
The Glean™ Urodynamics System (Glean Medical) is a novel, wireless, catheter-free ambulatory urodynamics device that measures intravesical bladder pressure during physiological (anterograde) bladder filling without transurethral catheters or retrograde saline filling — a fundamental departure from conventional urodynamics.[1][2]
Problem the System Addresses
Conventional urodynamics has well-recognized limitations:[3][4]
- Requires transurethral and rectal catheters — uncomfortable, embarrassing, painful.
- Uses rapid retrograde saline filling — nonphysiological.
- Results often poorly correlate with patient symptoms because the artificial setting fails to reproduce real-world bladder behavior.
- The urethral catheter itself impedes voiding, especially in neurogenic bladder — Gross 2026 showed standard UDS catheters significantly increased PVR vs catheter-free monitoring.[5]
- Single short clinic window, potentially missing intermittent pathology.
Ambulatory urodynamic monitoring (AUM) addresses some of these issues with physiologic anterograde filling, but traditional AUM still uses catheters.[3]
Device Design
The Glean system has an intravesical bladder sensor (Urodynamics Monitor, UM) and an external wireless receiver.[1][5]
The intravesical sensor is a ring (C-shaped / toroidal) medical-grade silicone device, ~45 mm outer diameter, 5.1 mm (15.3 Fr) cross-section, containing:[5]
- Pressure sensor.
- Lithium-ion battery.
- Flexible circuit board.
- Wireless antenna.
- Medical-grade silicone oil filling the housing for pressure transduction.
- Retrieval suture for transurethral extraction.
The ring shape prevents expulsion during voiding while staying small enough for transurethral insertion and comfortable enough to not impede LUT function.[1][5]
How It Works
- Transurethral insertion — median 33.6 sec (range 12–256 sec).[1]
- Ambulatory monitoring — continuous wireless pressure data while the patient drinks fluids and goes about normal activities (physiologic anterograde filling).
- Voiding — patients void normally with the sensor in place; 100% (32/32) of MUSE participants voided successfully with the sensor indwelling.[1]
- Removal — transurethral via the retrieval suture; median 5.7 sec (range 0.8–22 sec).[1]
Clinical Evidence
MUSE Trial — Pivotal Feasibility Study
Prospective single-arm multicenter interventional trial; n = 38 adults with LUTD:[1]
| Parameter | Result |
|---|---|
| Sensor insertion success | 97.0% (32/33) |
| Median insertion time | 33.6 sec |
| Median removal time | 5.7 sec |
| Patients able to void with sensor | 100% |
| Vesical pressure recording | Successful in all |
| Total AEs | 14 in 12 participants |
| Device-related AEs | 7 in 7 participants |
| Serious AEs | 0 |
| Patient / clinician feedback | Positive; easy to use |
Bench-Top Comparative Performance
Hamson 2026 — 30 Glean sensors vs 30 air-charged catheters (Laborie Goby) in a human bladder model with stepped, sinusoidal, and ramping pressure simulations:[2]
| Metric | Glean | Laborie Goby | p |
|---|---|---|---|
| Rise time | 0.104 sec | 0.172 sec | 0.001 |
| Fall time | 0.111 sec | 0.264 sec | 0.001 |
| Bandwidth | 4.978 Hz (near 5 Hz max) | 2.250 Hz | 0.001 |
| Maximum error | 6.882 | 21.549 | 0.001 |
| Linearity | Superior | Good | 0.001 |
Glean significantly outperformed conventional air-charged catheters across all dynamic-response, bandwidth, and accuracy metrics.[2]
Neurogenic Bladder Validation (Gross 2026)
In women with MS-related neurogenic bladder, standard UDS catheters significantly impaired emptying (elevated PVR), whereas the wireless catheter-free device enabled more physiologic voiding patterns with lower PVRs.[5] Critical signal because neurogenic-bladder patients often cannot void around a urethral catheter, making conventional UDS results potentially misleading.
Developmental Lineage — UroMonitor
The Glean evolved from the UroMonitor — the first catheter-free wireless ambulatory bladder pressure monitor tested in humans. Frainey 2023 first-in-human (n = 11 women with OAB):[6]
- Captured 98% (85/87) of voiding and non-voiding urodynamic events vs simultaneous conventional UDS.
- All subjects voided with only the UroMonitor in place with low PVR.
- Median ambulatory pain score 0 (range 0–2) on a 0–5 scale.
- No post-procedural infections; no significant changes to capacity, sensation, or flow.
Glean vs Conventional UDS
| Feature | Glean | Conventional UDS |
|---|---|---|
| Catheter required | None | Urethral + rectal |
| Bladder filling | Physiologic anterograde | Non-physiologic retrograde saline |
| Setting | Ambulatory (free movement) | Clinic-based, restricted positioning |
| Voiding | 100% normal with sensor | Impaired by catheter |
| Pressure accuracy | Superior (lower max error, faster response) | Standard |
| Patient comfort | Positive | Often embarrassing / painful |
| Symptom reproduction | More physiologic conditions | Often fails to reproduce |
| Monitoring window | Extended ambulatory | Short clinic-based |
Clinical Use Cases
- Refractory OAB / UUI — capture urgency episodes in the patient's daily environment.
- Neurogenic bladder — where clinic UDS is technically difficult or produces equivocal data.
- Post-prostatectomy / post-radiation incontinence — real-life conditions.
- Pre-operative evaluation before complex reconstruction.
- Symptom-signal correlation — pair ambulatory pressure with voiding diary.
Limitations & Unknowns
- Measures vesical pressure only — no abdominal-pressure measurement (no rectal catheter), so detrusor pressure cannot be directly calculated (P_det = P_ves − P_abd). Cannot directly distinguish detrusor contraction from abdominal straining.[1][3]
- No continuous volume measurement — needed for compliance calculations.[3]
- Early-stage evidence — one feasibility trial (n = 38) and one bench comparison. Larger comparative trials with clinical-outcome endpoints needed.[1][2]
- Regulatory status — MUSE was conducted under an investigational protocol; specific FDA clearance / approval for commercial use is not fully detailed in the published literature.[1]
- Patient population — most evidence is in women; male data are limited (urethral anatomy differs).
- No long-term monitoring data — extended (hours to days) feasibility and safety with the Glean specifically have not been fully characterized.
Broader Wireless-Bladder-Monitoring Landscape
Glean is part of a wave of telemetric ambulatory urodynamic monitoring (TAUM) devices.[3]
- UroMonitor — Glean predecessor; 98% event detection in first-in-human.[6]
- UroMOCA — implantable (12 × 18 × 6 mm) with pressure + impedance-based volume sensing + wireless recharge; tested in animals up to 28 days.[7]
- WiCa (Wille capsule) — C-shaped intravesical capsule for multi-day monitoring; in vitro testing.[8]
- Bladder Pill — wireless intravesical device, inductive coupling; tested in minipigs.[9]
The Glean is the most clinically advanced of these devices — largest human feasibility dataset and the only bench-top comparison against a commercially available conventional UDS system.[1][2]
See also: Intermittent Catheter, Urodynamics.
References
1. 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
2. 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
3. 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
4. Clement KD, Burden H, Warren K, et al. Invasive Urodynamic Studies for the Management of Lower Urinary Tract Symptoms (LUTS) in Men With Voiding Dysfunction. Cochrane Database of Systematic Reviews. 2015;(4):CD011179. doi:10.1002/14651858.CD011179.pub2
5. 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
6. 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
7. 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
8. 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
9. 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