Frequently Asked Questions

For who?

Who can use the SENS-U Bladder Sensor?

The SENS-U kids is intended for children between age 6 and 12 who are under treatment by a medical professional. Children who are late with toilet training learn to go to the toilet when the bladder is full. Children with a neurogenic bladder can use the SENS-U for volume based intermittent catheterization.

Will there be a SENS-U Bladder Sensor for people from all ages?

The next version of the SENS-U will be intended for people dealing with incontinence and who need support with bladder management of all ages.

Regulatory Compliance

Does the SENS-U Bladder Sensor have CE certification?

The SENS-U Bladder Sensor is a medical class IIa device and has a CE mark since March 2018.

Does Novioscan have an ISO certification?

Novioscan is ISO 13485 certified since March 2018.

What is Novioscan’s Privacy Policy?

You can find our Privacy Policy via this link.

During use

What do you need to start using the SENS-U Bladder Sensor?

Everything you need is included in the SENS-U Starterkit: Adhesive patches, ultrasound gel, alcohol swabs and the SENS-U. You will also need a smartphone to download the SENS-U app to adjust the SENS-U to your personal settings. The app can be found in the Play Store and Apple Store

How are the SENS-U and smartphone connected?

The SENS-U and the smartphone are connected via Bluetooth Low Energy.

Can the SENS-U be connected to more than one smartphone?

The SENS-U can be connected to one smartphone. It is possible to forward the full bladder notification to a second smartphone, this option can be found in the menu behind the bell icon.


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How does it work

How does the SENS-U Bladder Sensor work?

The SENS-U monitors the filling of the bladder and gives a notification when the bladder is nearly full via a vibration in the SENS-U and/or a message on a smartphone. The user is notified that the bladder is full and action should be taken. The SENS-U Bladder Sensor helps to prevent unwanted urinary loss.

How does the SENS-U Bladder Sensor operate?

The SENS-U is a non-invasive wearable sensor using ultrasound technology to measure bladder filling. The SENS-U Bladder Sensor is placed on the lower abdomen with an adhesive patch. Between the sensor and the skin, ultrasound gel and an adhesive patch are used to ensure ultrasound conduction and fixation. The sensor data is pre-processed in the scanner, and data is sent to a smartphone using Bluetooth.

Clinical Evidence

What clinical evidence of the SENS-U Bladder Sensor is available?

The SENS-U Bladder Sensor is clinical validated in collaboration with the University Medical Center Utrecht, the Netherlands. The results of the validation studies are published in the Journal of Pediatric Urology. An overview of the latest scientific literature can be found via this link.

There are several SENS-U related clinical investigations ongoing, please contact us for the latest update or if you are interested in performing clinical research with the SENS-U.

How to get a SENS-U

Where is the SENS-U Bladder Sensor available?

The SENS-U Bladder Sensor is available in Europe for healthcare providers. Healthcare providers can purchase the SENS-U and use it for their patients.

How can you purchase the SENS-U Bladder Sensor?

Healthcare providers can purchase the SENS-U directly from us or via their local distributor. Please contact us for more information.