Evaluating Normal Urodynamics Parameters Using the Glean System in Healthy Adults Aged 18 to 45

What this Trial Is About

This research aims to establish normal reference ranges for urodynamics parameters in healthy adults aged 18 to 45 using the Glean Urodynamics System. The study is open-label and interventional, focusing on evaluating bladder and abdominal pressure measurements among participants without known urinary tract conditions. Participants will have the Glean Urodynamics System inserted, which includes a bladder pressure sensor, abdominal pressure sensor, an in-clinic uroflowmeter, and software applications. After an in-clinic ambulatory monitoring period, participants will be discharged with the bladder sensor in place for continued monitoring outside the clinic for up to 24 hours. The sensor will be removed within 24 hours after insertion. During the study, participants will undergo in-clinic monitoring followed by home monitoring with the sensor. A follow-up phone call will occur 7 days after sensor removal. Researchers will measure vesical pressure ranges during the procedure and monitor participants for any changes or issues related to the device. The total participation time includes the monitoring period plus follow-up contact to ensure safety and data completeness.

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