Glean™ Urodynamics System
The Glean™ Urodynamics System (Bright Uro) is the first wireless, catheter-free ambulatory urodynamics platform — FDA 510(k) cleared in 2025. A small flexible sensor is inserted transurethrally into the bladder, where it coils to self-retain, transmits bladder-pressure data via Bluetooth to a patient-worn receiver, and is retrieved after hours-to-days of ambulatory recording via a thin retention string.
Design
- Silicone sensor tube housing a miniature pressure transducer
- Self-coiling bladder retention — the tube curls into a coil once deployed inside the bladder (similar principle to a pigtail catheter coil)
- Bluetooth transmitter — continuous wireless data streaming to a patient-worn receiver
- Retrieval string — thin tether exits the urethra, taped to the perineum / thigh
- Retrieval — patient (or clinician) pulls the string; the sensor uncoils and exits the urethra in <6 seconds
What It Solves
Traditional catheter-based office urodynamics (UDS) carries well-known limitations:
- Catheter-in-urethra distorts outlet dynamics — the very thing the test is trying to measure
- Artificial clinic environment — patient not in natural voiding conditions; performance anxiety
- Forced bladder filling — not physiologic; misses the low-compliance / urgency patterns that emerge during natural filling
- Single time-point — one session cannot capture diurnal variation
- Patient discomfort and embarrassment — reduces willingness to undergo repeat or follow-up studies
The Glean addresses each: no catheter in the urethra during recording, natural ambulatory conditions, physiologic filling, multi-hour-to-overnight monitoring, minimal patient discomfort.
Clinical Use Cases
- Refractory OAB / UUI — capture urgency episodes in the patient's daily environment
- Neurogenic bladder — particularly in patients in whom clinic UDS is technically difficult or produces equivocal data
- Post-prostatectomy / post-radiation incontinence — characterize the pattern in real-life conditions
- Pre-operative evaluation before complex reconstruction
- Symptom-signal correlation — pair ambulatory urodynamic pressures with patient-kept voiding diary
Where It's Deployed
Cleveland Clinic was the first site to use the Glean commercially in June 2025. Adoption is expanding through academic urology and urogynecology programs with dedicated urodynamics practices.
Limitations
- New technology — real-world comparison data against conventional UDS still accumulating
- Insurance coverage — variable at this early stage
- Patient self-retrieval — the retrieval-string mechanism requires patient cooperation
- Cost — disposable sensor component adds per-study cost
See also: Intermittent Catheter, Urodynamics (traditional UDS reference).