Para/Medic: BioFlo, a New Option for Indwelling Catheter Users


BobOct14

Q. I’m 22,  in my second year as a C5-6 quad and have had a suprapubic catheter since rehab. It works well, but I’ve also had my share of UTIs — I think because some of my attendants are lax at keeping the end of the Foley tube clean when changing from leg bag to night bag, as well as plugging the tube when I bathe and dress.

A friend, also a C5-6 quad with a suprapubic, hasn’t gotten any UTIs. He attributes this to using a “closed system” made by BioFlo. It also has an extra attachment that allows him to go without a leg bag during the day — emptying his bladder every couple of hours with a lever he can manipulate with his thumb. It looks convenient, but I’ve always heard you should never clamp off a Foley for more than 15-20 minutes.

Have you heard of this system?
— Brent

A. Brent, according to Paralyzed Veterans of America’s Bladder Management for Adults with Spinal Cord Injury, A Clinical Practice Guide, long term use of indwelling catheters — whether urethral or suprapubic (a Foley catheter that enters the bladder via a stoma near the navel) — is associated with recurrent urinary tract infections.

The patented BioFlo system, for use with indwelling catheters, has been on the market for about a year. The heart of BioFlo is an inline system called the AutoValve. The drain end of a Foley tube fits onto and stays on the receiving end of the AutoValve. The discharge end fits into Quick Disconnects, which are attached to BioFlo collection bags. The unit has a spring-loaded valve that closes when a disconnect is removed (a closed system that keeps out bacteria). Another unique feature is an automated system that creates a fill and void cycle of urine in the bladder. When pressure reaches 20 cm (about 20 ml of urine in the bladder) two magnets inside the AutoValve separate and the bladder empties. And it has a capped luer lock port (leak-free fluid connection) — for irrigation.

Shepherd Rehab Center in Atlanta, Ga., started an ongoing trial of BioFlo with their inpatients in 2012. Susan Bowen, RN, director of quality outcomes and patient safety, says that within the first six months, the BioFlo group reduced catheter-associated urinary tract infections by 50 percent. The BioFlo AutoValve is now Shepherd’s standard urinary device for indwelling catheters. “In our trial, the main way the BioFlo reduced catheter-associated UTIs is its closed system,” says Bowen. “The magnetic closing system of the AutoValve also stops urine backflow to the bladder, and when we need to change out bags to change clothes, it closes and the person isn’t exposed to harmful bacteria.”

The Shepherd numbers are impressive, says Bernadette Mauro, director of information and resource services for Christopher & Dana Reeve Foundation Paralysis Resource Center. “I work at staying on top of options that can improve the health of people with SCI. My interest in BioFlo is based on the numbers I was seeing during the Shepherd study that go back to early 2014,” she says. “I saw a demonstration of the device, got to use the disconnect system myself, detach it from the bag and connect it, and it appears there is no way to contaminate it.”

Mauro says that because the Shepherd study showed a 50 percent reduction of catheter-associated UTIs in inpatients, it is reasonable to infer it would also work to minimize infection rate in the home. “In my opinion it is a reasonable option for people to explore with their physician, especially individuals with higher injuries or a number of different caregivers or attendants, who can’t closely control the quality of how their Foley is handled,” says Mauro. “If it can reduce infections and risk of sepsis, then you are increasing quality of life.”

Touro Rehab in New Orleans recently completed a six-month inpatient trial of the AutoValve and didn’t have a single case of catheter-associated UTIs, according to the nursing director there.

Another benefit of the AutoValve is letting urine build up in the bladder, then drain, says Dr. Michael Kennelly, director of urology at Carolinas Rehab in Charlotte, N.C. He explains that when a free-flowing indwelling catheter empties the bladder, the Foley balloon and catheter tip is in contact with and rubbing and irritating the bladder mucosa (inner coating of the bladder wall), which creates sentiment. Because AutoValve lets urine build up in the bladder, then drain, the Foley balloon and catheter tip is in a liquid environment, so it isn’t always rubbing. “I want to research whether the reduced rubbing reduces catheter-associated UTIs and potentially improves the bladder mucosa.”

Another BioFlo option is the ActiValve, a small manually-operated flip-to-open valve on a drain tube that can be operated by quads with limited dexterity and connects directly to the AutoValve. This gives a user the option to ditch the leg bag during the day and drain their bladder like users who are on an intermittent cathing schedule.

Another benefit of the AutoValve may be preserving bladder capacity.  Kennelly — who has 20 years experience working with people who have SCI — explains that long-term use of a free-flowing indwelling system causes the bladder to lose elasticity and size and can eventually shrink down to the size of a Foley balloon, something that is irreversible.

In the U.S., the practice is to leave urethral Foleys or SP tubes with continuous drainage. However, in the UK it has been common to use catheter valves and do bladder cycling for years — under the right conditions, says Kennelly. He adds that the UK National Institute for Health and Clinical Excellence policy states that catheter valves promote normal detrusor muscle (wall of the bladder) function. “If bladders are allowed to remain on long term continual free drainage, bladder function can be lost and may not return,” he says.

A word of warning: Bladder cycling should only be done after a thorough discussion and evaluation by a urologist to determine if your bladder meets the criteria. Never plug or clamp a Foley for more than 20 minutes without this discussion. It can cause severe problems, including autonomic dysreflexia, and permanent kidney damage.

What are the right conditions for an AutoValve? Kennelly says it starts with a good relationship with your urologist and a urodynamic test to look at bladder volume and spasms and to see if the person’s body gives them clues. This doesn’t necessarily mean bladder sensation, but a more subtle physiological response like a slight tingle, which provides an awareness that their bladder is getting full and it’s time to drain (not autonomic dysreflexia). “If they don’t have this awareness, then they need to have a naturally large bladder capacity where I can comfortably say, ‘OK you need to empty every three hours,’” he says. “And bladder spasticity must be under control — either from Botox or other medications.”

Also required is the ability to release the drain lever with a thumb or palm, and they must be motivated to drain on a frequent basis and understand the importance and dangers (autonomic dysreflexia, kidney damage) of high bladder pressure. “Clearly this is not a good option for people that have difficulty with autonomic dysreflexia.”

Currently Kennelly has three outpatients on the BioFlo system. He would like to have more but is waiting for insurance funding for the AutoValve, which retails for $92 and should be replaced once a month.

Brent, hopefully the system will be approved for reimbursement soon so you can discuss with your urologist whether this may be a good option for you.


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