Indications for Use

Description: The Glean Urodynamics System (GUS) conducts standard urodynamic tests like Uroflow (UF), Cystometrogram (CMG), Urethral Pressure Profile (UPP), and Micturition Studies (MS). It includes three physical components—the Sensor, Insertion Tool, and Uroflowmeter—and three software applications: the Glean Mobile App for Clinicians, the Glean Mobile App for Patients, and the Glean Web App for clinicians. Patients use the Patient App to log urological symptoms, while clinicians use the Clinician App to manage and download data from the Sensor and Uroflowmeter. The Web App allows clinicians to analyze data and generate reports. The Sensor, inserted into the bladder, collects data wirelessly downloaded to the Clinician App. The Uroflowmeter measures voided volume and flow, with data synchronized in the cloud for comprehensive analysis and reporting.

Sensor, Insertion Tool, Packaging

Description: The Sensor is a long, flexible, disposable device designed for urodynamic monitoring, inserted into the bladder via the urethra using the Insertion Tool. It features a silicone outer housing containing a battery, electronic circuit board with a microprocessor, software, Bluetooth module, pressure sensor, and memory. Once inside the bladder, the Sensor curls into a circular shape and collects data until removal, which is facilitated by pulling a Removal String. The Sensor and Insertion Tool are packaged in a sterile kit, differentiated by gender with blue (male) and pink (female) stickers, and should be inspected for damage before use.

Uroflowmeter

Description: The Uroflowmeter measures urine volume and flow during voiding and is compatible with common commodes and urine collection cups. Packaged in a box with a magnetic lid, it includes a welcome letter, symbols glossary, and a quick start guide with a unique QR code and PIN. The device features a capacitive touch button for power and LED indicators for operation modes. The Ring LED pulses blue when on, turns solid blue during data collection, and flashes once data is downloading. The Button LED shows connectivity and battery status, changing color to indicate low or critical battery levels. The Uroflowmeter can be magnetically coupled to a charging pad for continuous use while charging.

Software

Description: The Glean Urodynamics System includes three software applications: the Glean Mobile App for Clinicians, the Glean Mobile App for Patients, and the Glean Web App. Clinicians use the Clinician App to prepare the Sensor for insertion and download data from the Sensor or Uroflowmeter. Patients use the Patient App to maintain a digital voiding diary, logging fluid intake, leakage, urgency, and other symptoms. Data from both apps syncs in the cloud for clinicians to review, analyze, and generate reports using the Web App. The apps are available for download on the Apple App Store and Google Play Store by searching “Glean UDS.”

Gather Common Accessories

Description: Commonly used accessories for the Glean Urodynamics System include materials for aseptic insertion such as a Foley Catheter Insertion Kit, sterile gloves, drapes, chucks, and iodine or similar cleansing agents. Additional items include water-based lubricant or lidocaine gel, a mobile device (tablet/phone) and desktop/laptop computer with internet access, a commode, a urine collection cup, and biohazard bags. For Cystometrogram (CMG) with Pressure Flow Studies (PF), the Glean Sensor measures vesical pressure as the bladder fills naturally, ensuring proper bladder and lower urinary tract function. Preparation involves readying the patient and the sensor while maintaining aseptic technique throughout the insertion process.

For Data Collection

Description: To prepare the Sensor for data collection, first inspect the labeling to select the appropriate sensor for the patient’s gender. Open the outer box and remove the pouch without unsealing it. Log in to the Clinician App, select “Start a New Study,” choose the correct patient, and confirm their information. Add the Sensor by pressing its button for over three seconds to power it on, scan the QR code on the pouch, and enter the PIN from the label. Calibrate the sensor by placing it on a flat surface. If the Sensor malfunctions, discard it and repeat the steps with a new Sensor. For aseptic insertion, wash hands, put on sterile gloves, and gather necessary items. Open the plastic tray, apply lubricant to the Sensor, align the Removal String with the sheath, and load the Sensor into the Sheath. Inspect the Sensor tip for proper alignment and make any necessary adjustments.

Male and Female

Description: To deploy the Sensor in the bladder for males, apply gentle traction to straighten the urethra and insert the Sensor tip into the urethra using the Sheath. Advance the Sheath while maintaining traction, then withdraw it slightly before using the Advancer to deploy the Sensor. Ensure urine flow confirms proper placement. If no urine flows, wait 20 seconds or reattempt with a new Sensor if needed. Secure the Removal String to the patient’s body and update the Clinician App with the deployment status. For females, expose the urethra, insert the Sensor using the Sheath, and advance it halfway. Deploy the Sensor with the Advancer, confirm urine flow, and secure the Removal String. Avoid pushing past resistance during both procedures, adjusting positioning or adding lubricant if necessary.

Using Clinician & Patient Apps

Description: To log events using the Clinician App, clinicians first login and can optionally perform guided maneuvers tailored to the patient’s history and goals. They select the patient for the study, add events, and choose from various options like cough, Valsalva, or voiding events. They guide patients through maneuvers if needed, confirm event details, and save them. For cough or Valsalva, clinicians start and stop timers while the patient performs the maneuver. For other events, they log simultaneously with patient action. Date and time adjustments require justification. During ambulatory monitoring, patients use the Patient App to log symptoms, following guidance provided by clinicians. Clinicians instruct patients on using the Patient App and may provide a pen and paper option. Training patients to use the Patient App involves logging in, adding events, entering data, editing, and deleting events as needed.

Description: A Uroflow Test measures the rate of urine flow and can be conducted using the Glean Mobile App for Clinicians. Preparation involves gathering supplies such as a receptacle, commode chair, and funnel, and placing the Uroflowmeter on the floor with a urine collection cup atop. After logging into the Clinician App and selecting the patient profile, clinicians start the study and add the Uroflowmeter device. They then power on the Uroflowmeter, associate it with the patient profile, and initiate data collection. Patients are instructed not to disturb the urine collection cup during voiding, and once complete, clinicians stop data acquisition, download the Uroflowmetry data, and record any post-void residual (PVR) measurements if desired.

Download the Data

Description: Preparing the patient for Sensor removal involves gently removing any material securing the Sensor Removal String and carefully pulling the string until the Sensor is completely out of the body, placing it in a biohazard bag for disposal. If desired, Urethral Pressure Profile (UPP) testing can be conducted using the Glean system with a Manual Pull method, ensuring the bladder contains at least 50 mL of urine. Clinicians gently pull the removal string until resistance is felt at the bladder neck, then continue to pull slowly at a rate of 1 mm per second, taking approximately 3 minutes to fully remove the Sensor. Data from the Sensor is downloaded via the Glean Mobile App for Clinicians, where clinicians select the patient profile, initiate data download, and confirm data upload before disposing of the Sensor according to clinic guidelines.