Assessment of CymActive™ Catheter Technology for UrinAry ReTention and AcceptancE (The ACCTUATE Study)

"The cymactive™ catheter (manufactured by Ingenion Medical Ltd) received CE marking on the 28th March 2024, as a Class IIb device (n. ECM24MDR002 rev.0, Single Registration Number (SRN) of the Manufacturer UK-MF-000041065) and will be available in the UK market, subject to local arrangements.~The cymactive™ catheter is designed to remain in situ for up to 30 days, does not extend outside the patient's body except for 2 removal strings, and has an integral, magnetically controlled valve that allows the user to control their own urination. The study participant will each be supplied with a magnetic Actuator (a separate Class I device supplied by Ingenion Medical) so they are in control of valve and their own voiding. The magnet is strong and care will need to be taken to keep it at least 6 inches from magnetically-sensitive items, i.e. mobile phones, laptops and credit cards. Study participants should also avoid contact with MRI machines."

Routine standard of care. Usually replaced \~ 3 monthly