NCT07485205

Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Bright Uro · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A prospective, open-label, single arm interventional trial to establish normative reference ranges for urodynamics parameters in healthy adult participants using using the Glean Urodynamics System.

Detailed description

Subjects will have the Glean Urodynamics System inserted for an in-clinic ambulatory monitoring period. Afterward, they will be discharged with the Glean Bladder Sensor in place for continued monitoring outside the clinic, not exceeding 24 hours. The sensor will be removed within 24 hours of insertion. Subjects will receive a follow-up phone call 7 days post-removal.

Conditions

• Lower Urinary Tract Symptoms (LUTS)

Interventions

Type	Name	Description
DEVICE	Glean Urodynamics System	Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-03-20
• Last updated: 2026-04-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study