Q: Can you tell me anything about catheter valves? They are produced by Bard and Coloplast and approved for use in the UK. I have found some information on them via the Internet: “Catheter valves are used as an alternative to allowing urine to drain freely into a drainage bag. The valve is connected to the catheter outlet. Opening the valve at regular intervals drains urine. Catheter valves are more discreet than leg bags. And because urine is stored in the bladder, not a drainage bag, they can help keep the bladder in good working order.” Can we expect approval in the United States anytime soon?
A: Kathi, I researched the products you mentioned and provide links below. Catheter valves are designed to work with a Foley catheter, and the concept is fairly simple: A catheter valve fits into the outlet end of the Foley. The Foley prevents urine passing the urethral sphincter. When the catheter valve is closed, the bladder fills. When it’s time drain the bladder, you open the valve and void the urine. Under ideal conditions, this mimics the way a neurologically intact bladder fills and empties.
Under the right conditions, catheter valves look be a viable and discreet option. The “right conditions” include a flaccid (quiet) bladder, and a person diligent about emptying the bladder at regular intervals, as well as hand washing. In the case of a spastic bladder, the system has potential for serious trouble. When the bladder spasms it squeezes the urine; plug the exit with a catheter valve and the urine will back up through the ureters into the kidneys (reflux), which can cause permanent and life-threatening kidney damage. This can also cause scarring of the bladder. Reflux and scarring can also happen if the bladder gets too full before opening the valve. Hand washing is vital because bacteria on a Foley catheter can migrate down the bio-film into the bladder and cause a UTI.
At the moment the discussion is moot — neither Coloplast or Bard offer catheter valves in the United States. I contacted both companies and they cited lack of FDA approval as the reason. Both companies said the large expenditure of time, money, testing and paperwork required for potential FDA approval didn’t warrant the limited market for the device at this time. However, if Bladder Matters readers are interested in catheter valves, it couldn’t hurt to let the companies know.