Condom versus indwelling urinary catheters: a randomized trial.

OBJECTIVES To compare condom and indwelling urinary catheters in terms of infection risk and patient satisfaction. DESIGN A prospective, randomized, unblinded, controlled trial. SETTING An academically affiliated Veterans Affairs Medical Center. PARTICIPANTS Hospitalized men aged 40 and older who required a urinary collection device. MEASUREMENTS The incidence of adverse outcomes (bacteriuria, symptomatic urinary tract infection (UTI), or death) and patient device-related satisfaction as determined according to a questionnaire. Dementia status was recorded to assess effect modification by the presence of dementia. RESULTS Seventy-five subjects were randomized: 41 receiving an indwelling catheter and 34 a condom catheter. The incidence of an adverse outcome was 131/1,000 patient-days with an indwelling catheter and 70/1,000 patient-days with a condom catheter (P=.07). The median time to an adverse event was 7 days in the indwelling group and 11 days in the condom group. After adjusting for other risk factors, it was found that condom catheter use reduced adverse outcomes (P=.04). Patients without dementia who had an indwelling catheter were approximately five times as likely to develop bacteriuria or symptomatic UTI or to die (hazard ratio=4.84, 95% confidence interval=1.46-16.02) as those with a condom catheter (P=.01). Patients reported that condom catheters were more comfortable (P=.02) and less painful (P=.02) than indwelling catheters. CONCLUSION The use of condom catheters is less likely to lead to bacteriuria, symptomatic UTI, or death than the use of indwelling catheters. This protection is especially apparent in men without dementia.