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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
72
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.
Arizona Research Center
Phoenix, Arizona, United States
RECRUITINGDel Sol Research Management
Tucson, Arizona, United States
RECRUITINGPrestige Medical Group
Tustin, California, United States
RECRUITINGRange of vesical pressure (Pves)
Range of vesical pressure (Pves) in cm H2O as measured by the Glean Bladder Sensor
Time frame: Periprocedurally
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