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Senior Citizen Health & Medicine
Condom Catheter Makes Hospital Stay for Men Safer
and More Pleasant
Fewer infections, happier patients, seen with
external catheter
July 2, 2006 – There is great news for older men
about one of the greatest dreads men have about hospitalization – the
urinary catheter. The good news for men is that new research says there
is a much less-unpleasant option that also happens to be much safer,
with the unexplained exception of men with dementia. The new and
improved solution is a painless "condom" catheter.
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Health & Medicine |
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In a recent study, men whose urine was collected
with an external 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 non-painful.
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 their catheter.
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
monitoring.
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," he says.
Editor's Note: In addition to Saint and Lipsky, the
study's authors are Samuel R. Kaufman, M.A. and Mary A.M. Rogers, Ph.D.,
of U-M and the Ann Arbor VA, and Paul D. Baker, ARNP, and Kathleen
Ossenkop, ARNP, of the VA Puget Sound. The study was funded by the
Department of Veterans Affairs, the VA/U-M Patient Safety Enhancement
Program (PSEP), Mentor Corp., and the Robert Wood Johnson Clinical
Scholars Program.
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