Study of the Glean Urodynamics System for In-Clinic and Extended Lower Urinary Tract Monitoring in Adults

What this Trial Is About

Researchers are evaluating the safety and performance of the Glean Urodynamics System for monitoring the lower urinary tract. This prospective, open-label, single-arm interventional trial focuses on both in-clinic and extended monitoring periods. The study aims to assess how well this device works in clinical settings and during continued use outside the clinic. Participants will have the Glean Urodynamics System inserted, which includes a bladder pressure sensor, abdominal pressure sensor, uroflowmeter, and software applications. Initially, monitoring occurs in-clinic, followed by discharge with the bladder sensor in place for up to 24 hours of additional monitoring at home. The sensor is removed within 24 hours after insertion. Seven days following sensor removal, participants provide a urine sample and receive a follow-up phone call 14 days after the device is removed. During the study, participants will undergo monitoring with the device and provide a urine sample after one week. Researchers will track any adverse events related to the Glean Urodynamics System from the time of enrollment until 14 days after device removal. Follow-up phone calls help ensure participant safety and gather additional information. Participation duration includes the initial monitoring period, sample collection, and follow-up, lasting a few weeks in total.

Ambulatory Long Length URodynamics Evaluation