'Condom' catheter can improve outcomes
Study also indicates higher patient satisfaction
The unfortunate reality is that many medical procedures are uncomfortable but often necessary to achieve optimal outcomes. However, when there is an option to choose a less onerous procedure and not sacrifice quality, most quality managers would argue for that approach.
Thanks to a new study conducted by researchers at the University of Michigan at Ann Arbor, and Veterans Affairs hospitals in Seattle and Ann Arbor, just such an option appears to be available in many cases where a urinary catheter is indicated.
For years, there has been conflicting data about the safety of that option — a "condom" catheter — according to Sanjay Saint, MD, MPH, director of the patient safety enhancement program, associate professor of general medicine at the University of Michigan Medical School, and lead author of the article, which appeared in the Journal of the American Geriatric Society1. "We were aware of the observational studies that had looked at indwelling vs. condom catheters that showed conflicting results," he relates. "Some studies in the '80s showed indwelling catheters increased risk twofold, but recently there was a large study of nursing home patients in Denmark that showed just the opposite."
Experts had long advocated that a randomized controlled study be done, "So we decided based on the conflicting evidence that we would take that on," says Saint.
The study found that in men whose urine was collected with an external or "condom" catheter during their hospital stay, there was an 80% 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 condom catheters also were far more likely to be considered comfortable and non-painful — a finding that came as no surprise to Saint. "The next man who tells me they enjoy [the indwelling catheter] will be the first," he shares.
A significant difference
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, MD.
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. "After they gave us written informed consents, we basically flipped a coin," says Saint. "That's the gold standard way of assessing new devices."
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. In order to be good candidates for the condom catheter, Saint explains, "they would have to be cognitively intact. If they were confused and removed the condom catheter frequently, it could increase the risk of infection."
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 six for those with condom catheters. The indwelling catheter users developed the condition faster, on average within seven 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.
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% of the condom catheter users said the device was comfortable, and only 5% percent said it was painful, compared with about 58% and 36%, respectively, for indwelling catheter users.
Condom catheter recommended
Based on this research, Saint concludes that "in patients who can get either a condom or an indwelling catheter and who are not cognitively impaired, they should receive a condom catheter — not only because it is likely to lower the risk of infection, but because it also appears to be more comfortable," he says. "In patients, of course, who have medical indications for indwelling catheters, like obstruction of the bladder or urinary retention, the indwelling catheter is still the most appropriate way of collecting urine."
Saint adds that while the findings are likely to help men, "We still need a better external catheter for women. The current one that is available requires so much adhesive it is not practical," he says.
Meanwhile, the findings already have affected his decisions on the inpatient floors of the VA Ann Arbor Healthcare System. "Personally, when I have a man who does not meet the clinical criteria for an indwelling Foley and is mentally intact, I move to a condom catheter," he says. This includes men who have urinary incontinence and men who need to have their urine collected but are not critically ill.
As for other facilities, Saint says that, where appropriate, clinicians should now consider the condom catheter. He adds there are significant implications for quality managers seeking to raise patient satisfaction rates.
"I think there's been a real movement in terms of patient empowerment — personified by the motto, 'Nothing about me without me,'" he says. "You should always have the patient fully informed of the various alternatives, and where there is no negative outcome involved, we should do things the patient is more satisfied with. Personally, given a choice, I would prefer a condom catheter rather than an indwelling one, and probably many men in the same position would feel the same."
For more information, contact:
Sanjay Saint, MD, MPH, hospitalist, Ann Arbor VA Medical Center, Director, VA/UM Patient Safety Enhancement Program, Professor of Internal Medicine, University of Michigan Medical School, 300 North Ingalls Building Room 7E08 — Campus Box 0429, Ann Arbor, MI 48109-0429. Phone: (734) 615-8341. Fax: (7340 936-8944. E-mail:- [email protected].
Reference
- Saint S, Kaufman SR, Rogers MAM, Baker PD, Ossenkop K, and Lipsky BA. Condom Versus Indwelling Urinary Catheters: A Randomized Trial. J Am Geriatr Soc 2006; 54:1055-1061.
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