Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults
Bright Uro
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.
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.
Eligibility
- Age range
- 18–45 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Healthy male and female adults ages 18 to 45 years. 2. Patient is able to read, write, and communicate in English. 3. Patient is able to provide informed consent. 4. Patient owns, can independently operate, and is willing to use a smart device for study data collection purposes Exclusion Criteria: 1. Patient with any prior pregnancy (gravida ≥1), is currently pregnant (as confirmed by urine pregnancy test or medical history), or intends to become pregnant during the study period. 2. Patient has one or more symptoms indicative of a symptomatic urinary tract infection (…
Interventions
- DeviceGlean Urodynamics System
Glean Urodynamics System including a bladder pressure sensor, abdominal pressure sensor, in-clinic uroflowmeter, and software apps.
Locations (3)
- Arizona Research CenterPhoenix, Arizona
- Del Sol Research ManagementTucson, Arizona
- Boulder Medical CenterBoulder, Colorado