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Saturday 15th July, 2006
Far fewer infections, and happier
patients, seen with external 'condom' catheter
compared with indwelling type.
ANN ARBOR, Mich. -- It's one of the things about a hospital stay
that men loathe, and that infectious bacteria love: the urinary
catheter. Now, a new study shows that a less-unpleasant option
for male hospital patients is also a much safer one.
In fact, men whose urine was collected with an external or
"condom" catheter during their hospital stay had an 80 percent
reduction in the risk of urinary tract infection (UTI) or death
as compared with men whose urine was collected with the usual
"indwelling" catheter, the research shows. The condom catheters
were also far more likely to be seen as comfortable and
In the first-ever randomized, controlled trial comparing the
two types of catheters, that striking difference in infection
and death risk was seen in men who didn't have dementia and
didn't need an indwelling catheter for medical reasons. Other
men, and all women, should continue to use indwelling catheters,
the researchers say.
But since UTIs are the most common kind of infection to
strike patients in the hospital and can lead to fevers and
prolonged hospital stays, the results may have tremendous
implications, say the researchers from the University of
Michigan Health System and the VA hospitals in Seattle and Ann
Arbor, Mich. They are publishing their results in the July issue
of the Journal of the American Geriatrics Society.
"This is one of the bread-and-butter issues that adversely
affects the safety of many hospitalized patients, and that will
affect more of us as the population continues to age," says lead
author Sanjay Saint, M.D., M.P.H., director of the Patient
Safety Enhancement Program and an associate professor of general
medicine at the U-M Medical School. "It has implications for
many hospitalized patients, 25 percent of whom use catheters,
but also for patients in nursing homes and at home."
Saint and his colleagues carried out the trial at the VA
Puget Sound Health Care System, where it took several years to
find a sufficient number of men willing to be randomly assigned
to either type of catheter who also met all of the study's
criteria. Saint began the project during his Robert Wood Johnson
Clinical Scholars fellowship at the University of Washington,
working with senior author Benjamin Lipsky, M.D.
In all, 75 men met the study's enrollment criteria, with 41
receiving an indwelling catheter and the rest receiving one of
five sizes of a silicone condom catheter. Their health status
was tracked for up to 30 days, including regular testing of
their urine for bacteria (a pre-UTI condition called bacteriuria)
and monitoring for signs of UTI. The men completed
questionnaires about discomfort and other feelings related to
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The researchers recorded medical and demographic information
about the men, and nurses assessed their mental status, looking
for signs of dementia or other problems with cognition. The data
were analyzed in a way that allowed the researchers to assess
the incidence and time until onset of bacteriuria, and a
combined measure of bacteriuria, symptomatic UTI, and death,
while correcting for the effects of other factors.
The study showed that there were 11 new cases of bacteriuria
for every 100 days of hospitalization in patients with
indwelling catheters, compared to 6 for those with condom
catheters. The indwelling catheter users developed the condition
faster, on average within 7 days, compared with 13 days for
condom catheter users. The same differences were seen for the
combined measure of bacteriuria, symptomatic UTI, or death.
A striking difference emerged when the mental status of the
patient was taken into account. For patients without dementia,
indwelling catheter users were 4.8 times more likely than condom
catheter users to experience bacteriuria, symptomatic UTI, or
death. For patients with dementia, this difference was not seen.
The impact of dementia, Saint says, might be linked to the
tendency of cognitively impaired men to touch or try to remove
their catheters -- which results in the nurse having to clean
the area and change the device. This can disturb the bacteria in
the area and lead to infection.
In addition to being associated with a lower risk of
infection, the condom catheters were much better liked than the
indwelling ones, the study showed. Nearly 90 percent of the
condom catheter users said the device was comfortable and only 5
percent said they were painful, compared with about 58 percent
and 36 percent, respectively, for indwelling catheter users.
The study did not address the cost-effectiveness of using the
more expensive condom catheters, which allow for a secure fit,
are less likely to fall off than other kinds of condom
catheters, and can be used for 48 hours. But Saint suspects that
by reducing the incidence of bacteriuria, symptomatic UTI, and
death, the extra expense up front will pay for itself in the
end. The condom catheters in the study were donated by their
manufacturer, Mentor Corporation, along with a research grant to
Lipsky, but the company had no role in designing, conducting or
analyzing the results of the study.
Already, Saint says, the results of the study have affected
his decisions on the inpatient floors of the VA Ann Arbor
Healthcare System. "This has changed my own management of
patients, to the point where if a patient is cognitively intact,
won't remove the catheter, and doesn't have a medical reason for
an indwelling catheter, I will choose a condom catheter for
him," he says. He notes that patients with urinary tract
obstructions, such as prostate problems, cannot use condom
catheters. Neither can patients who received certain anesthetics
or those in intensive-care units who require close urine
The study builds on previous work by Saint and his colleagues
that found that silver-coated indwelling catheters were
associated with fewer UTIs than conventional indwelling
catheters in certain high-risk patients, and that a reminder
system for doctors and nurses could reduce the time patients
spend with a catheter.
"Sometimes we physicians just order a urinary catheter as a
knee-jerk response, instead of thinking through whether the
patient needs it," he says. "We should only use catheters when
necessary, and even then we should have reminders to prompt
discontinuation." Now, with the new results, he hopes that
clinicians in hospitals and nursing homes will stop to consider
whether a male patient can use a condom catheter rather than an
indwelling one. "Even if the infection rate were the same
between the two, we should err on the side of giving patients
the option they would probably prefer. The only drawback is that
we don't yet have an external device for women that works well,"