A randomized crossover study of silver-coated urinary catheters in hospitalized patients. Efficacy of antimicrobial-impregnated bladder catheters in reducing catheter-associated bacteriuria: a prospective, randomized, multicenter clinical trial. Assessment of nosocomial urinary tract infections in orthopaedic patients: a prospective and comparative study using two different catheters. Clinical application of the Bardex IC Foley catheter. Siliconized Foley catheters. [A controlled trial of a new material for coating urinary catheters]. Comparison of urethral reaction to full silicone, hydrogen-coated and siliconised latex catheters. Prevention of catheter-associated urinary tract infection with a silver oxide-coated urinary catheter: clinical and microbiologic correlates. A large randomized clinical trial of a silver-impregnated urinary catheter: lack of efficacy and staphylococcal superinfection. Randomized multi-centre trial of the effects of a catheter coated with hydrogel and silver salts on the incidence of hospital-acquired urinary tract infections. Infection risk with nitrofurazone-impregnated urinary catheters in trauma patients: a randomized trial. Comparison of hydrophilic polymer-coated latex, uncoated latex and PVC indwelling balloon catheters in the prevention of urinary infection. [Clinical study on efficacy of a Foley catheter coated with silver-protein in prevention of urinary tract infections]. Silver alloy coated catheters reduce catheter-associated bacteriuria. A comparative multicentre study on the incidence of catheter-associated urinary tract infection between nitrofurazone-coated and silicone catheters. Refinements in the coating of urethral catheters reduces the incidence of catheter-associated bacteriuria. An experimental and clinical study.
Urinary tract infections (UTIs) account for 30% to 40% of nosocomial infections resulting in morbidity, mortality, and increased length of hospital stay.
                To assess the efficacy of a silver-alloy, hydrogel-coated latex urinary catheter for the prevention of nosocomial catheter-associated UTIs.
                A 12-month randomized crossover trial compared rates of nosocomial catheter-associated UTI in patients with silver-coated and uncoated catheters. A cost analysis was conducted.
                There were 343 infections among 27,878 patients (1.23 infections per 100 patients) during 114,368 patient-days (3.00 infections per 1000 patient-days). The relative risk of infection per 1000 patient-days was 0.79 (95% confidence interval, 0.63-0.99; P =.04) for study wards randomized to silver-coated catheters compared with those randomized to uncoated catheters. Infections occurred in 291 of 11,032 catheters used on study units (2.64 infections per 100 catheters). The relative risk of infection per 100 silver-coated catheters used on study wards compared with uncoated catheters was 0.68 (95% confidence interval, 0.54-0.86; P =.001). Fourteen catheter-associated UTIs (4.1%) were complicated by secondary bloodstream infection. One death appeared related to the secondary infection. Estimated hospital cost savings with the use of the silver-coated catheters ranged from $14,456 to $573,293.
                The risk of infection declined by 21% among study wards randomized to silver-coated catheters and by 32% among patients in whom silver-coated catheters were used on the wards. Use of the more expensive silver-coated catheter appeared to offer cost savings by preventing excess hospital costs from nosocomial UTI associated with catheter use. Arch Intern Med. 2000;160:3294-3298. To examine the efficacy of bladder catheters impregnated with minocycline and rifampin in reducing catheter-associated bacteriuria.
                A prospective, randomized clinical trial was conducted at five academic medical centers. Patients undergoing radical prostatectomy were randomized to receive intraoperatively either regular silicone bladder catheters (control catheters) or silicone bladder catheters impregnated with minocycline and rifampin (antimicrobial-impregnated catheters). Catheters remained in place for a mean of 2 weeks. Urine cultures were obtained at about 3, 7, and 14 days after catheter insertion. Bacteriuria was defined as the growth of organism(s) in urine at a concentration of 10(4) colony-forming units per milliliter or greater.
                Kaplan-Meier analysis demonstrated that it took significantly longer for patients (n = 56) who received the antimicrobial-impregnated catheters to develop bacteriuria than those (n = 68) who received the control catheters (P = 0.006 by the log-rank test). Patients who received the antimicrobial-impregnated catheters had significantly lower rates of bacteriuria than those in the control group both at day 7 (15.2% versus 39.7%) and at day 14 (58.5% versus 83.5%) after catheter insertion. Patients who received the antimicrobial-impregnated catheters had significantly lower rates of gram-positive bacteriuria than the control group (7.1% versus 38.2%; P <0.001) but similar rates of gram-negative bacteriuria (46.4% versus 47.1%) and candiduria (3.6% versus 2.9%). The antimicrobial-impregnated catheters provided zones of inhibition against Enterococcus faecalis and Escherichia coli, both at baseline and on removal.
                Bladder catheters impregnated with minocycline and rifampin significantly reduced the rate of gram-positive catheter-associated bacteriuria up to 2 weeks after catheter insertion. Catheter-related nosocomial urinary tract infection in postoperative orthopedic and trauma patients was studied prospectively using nitrofuroxone-impregnated urinary catheters (study group) and regular silicone-coated Foley catheters. Fifty adults in each group were randomly assigned. In Group A, antibiotic-impregnated catheters were used, and in the other, non-antibiotic-impregnated urinary catheters were used (Group B). The variables studied were age, sex, type of surgery, duration of surgery, number of catheter days, days of intravenous line, and hospital days. In patients, urinary tract infection (UTI) was diagnosed by culture and the organism was isolated. The average age in the study group was 43.90 years (range, 14-95 years) compared with the control group (mean age, 42.22 years; range, 14-102 years). Catheter days in the nitrofuroxone-impregnated catheters was 7.9 days (range, 2-37 days) versus 7.2 days (range, 2-30 days). The intravenous line in the group was 9.16 days (range, 2-35 days) versus 8.8 days (2-22 days). There were six infections (P = 0.028) in the control group compared with the study group. The length of operation was similar in each group. Our study indicates that nitrofuroxone-impregnated catheters have the potential to reduce nosocomial catheter-related UTIs in postoperative orthopedic and trauma patients. We performed two randomized prospective studies with the silver-coated Bardex IC catheter in order to evaluate the incidence of bacteriuria during short- and medium-term catheterization after urological procedures.
                During catheterization only consecutive suprapubic urine samples were taken and cultured. After removal of the catheter the patient was allowed one wash-out void, and before the second micturition a suprapubic puncture was performed to collect a culture specimen.
                In the first trial, after radical prostatectomy 18 patients with the Bardex IC catheter were compared to 17 patients with a silicon catheter after the same procedure. There was no significant difference in bacteriuria after 14 days (50.0 vs. 53.3%). In the second part of the study 180 patients were evaluated 101 with latex and 79 with Bardex IC catheters. The median catheterization time was 5 days. The results show a significant delay in the onset of bacteriuria when a silver alloy catheter is used (p < 0.003). On day 5 only 6.3% had bacteriuria in the Bardex IC group versus 11.9% in the latex group.
                We conclude that, after urological procedures, short-term catheterization with the Bardex IC catheter is superior to the classical latex catheter. nan Hydrogel is a highly biocompatible material which is used for coating Foley catheters. It has, in vitro and in vivo, demonstrated the lack of irritation to the surrounding urothelium. This controlled, randomized trial study the effectiveness of hydrogel-coated catheter (H catheter) compared with silicone-coated catheter (S catheter) in the prevention of nosocomial urinary tract infections (N.U.T.I.) for intensive care patients. To be included in this trial, subjects should have no urinary tract infection and no Foley catheters. Preliminary results concern 266 subjects (129 with H catheter, 137 with S catheter) Sex ratio M:F was 0.95; mean age was 50.7 years. The main criteria of judgement was the cumulative incidence of N.U.T.I. There was no significant difference between the two groups: 15.8% for H catheter versus 12.9% for S catheter. In the two groups mean duration of catheterization was longer for patients with N.U.T.I. Other evaluations seem to be necessary in order to confirm these results. Indwelling urinary catheter may induce an inflammatory reaction or even stricture of the urethra. Catheter encrustation and urinary infection are other disadvantages associated with long-term catheterisation. In the present study, 77 male patients were catheterised randomly as part of their normal treatment with 1 of 3 different types of catheter: 22 siliconised latex, 28 hydrogel-coated latex and 27 full silicone catheters. The mean duration of catheterisation was 2.2 days. The urethral inflammatory reaction was assessed from cytological urethral swab specimens. Catheter encrustation was studied using scanning electron microscopic (SEM) analysis. The full silicone catheters induced the mildest degree of inflammation in the urethra, the percentage mean of inflammatory cells in smears being 20%. In both latex catheter groups the value was 36%. Neither the age of the patients nor the duration of catheterisation had any effect on the inflammatory reaction, which was more marked in patients with haemodynamic abnormalities. The hydrogel coating effectively prevented encrustation, while siliconised latex catheters were the least resistant to encrustation. The inflammatory reaction was variable in all patients. The use of urethral catheters should be restricted and suprapubic tubes should be used instead, particularly in patients with shock-like circulatory changes. By developing the biocompatibility and physical properties of urinary catheters, more compatible devices may be manufactured. In a prospective clinical trial involving 482 acutely hospitalized patients, the overall incidence of catheter-associated urinary tract infection (UTI; 10%) was similar in recipients of a silver oxide-coated urinary catheter (silver catheter) or a control silicone catheter. However, female sex and absence of antimicrobial use were independently associated with an increased risk of UTI. After stratification for these variables, the silver catheter reduced the incidence of UTI among women not receiving antimicrobial agents (19% for control catheter vs. 0 for silver catheter, P = .04; confidence interval for the difference in incidence, 0.4%-38%) but not in the other subgroups. Gram-positive UTI was associated with absence of antimicrobial use, the control catheter, and catheter care violations. Gram-negative and candidal UTIs were more common after 7 days of catheterization, and candidal UTI was associated with being female and antimicrobial use. These findings demonstrate that several clinical variables influenced the incidence and microbiology of catheter-associated UTI and that the silver catheter appeared to prevent UTI among women not receiving antimicrobials. The antibacterial activity of silver-containing compounds has recently been employed in constructing medical devices, such as vascular and urinary catheters, that may be effective in blocking infection. The present study was designed to evaluate the efficacy of a silver oxide-coated urinary catheter.
                A total of 1,309 hospitalized patients who required placement of an indwelling urinary catheter for 24 hours or longer were randomly assigned to receive either a silicone catheter coated externally with 5% silver oxide or a standard silicone elastomer-coated latex catheter. Daily catheter-urine specimens were collected aseptically and catheter-care violations were monitored daily for the duration of the catheterization.
                Bacteriuria developed in 85 of 745 patients (11.4%) in the silver-coated catheter group and in 73 of 564 patients (12.9%) in the control group (P = 0.45). In women who did not receive antibiotics, the rates were 29.3% and 30.4%, respectively (P = 0.98). In men who did not receive antibiotics, the rate of bacteriuria was significantly higher with the silver-coated catheter (29.4% compared to 8.3%, respectively, P = 0.02). Staphylococcal species were isolated more often from the silver-coated catheter group than from the control group (25% versus 8% of all isolates, respectively, P = 0.002).
                This study, the largest ever reported evaluating any silver-impregnated device, has not only failed to demonstrate the efficacy of silver in prevention of catheter-associated bacteriuria, as suggested in prior studies, but it has also shown a significantly increased incidence of bacteriuria in male patients and a significantly increased occurrence of staphylococcal bacteriuria. These results suggest the need for caution and for similar large-scale trials before silver-containing compounds are widely used for preventing device-associated infections, both in vascular and urinary catheters. Catheters coated with hydrogel and silver salts have been proposed to prevent hospital-acquired urinary tract infections (UTI). We carried out a randomized, prospective, double-blind multi-centre trial to compare those catheters with classical urinary tract catheters. We included in the study 199 patients requiring urethral catheterization for more than three days: 109 in group 1 (classical catheter) and 90 in group 2 (catheter coated with hydrogel and silver salts). Urine from the patients was tested for 10 days after the insertion of the catheter (reactive dipsticks each day and diagnostic urinalysis every two days). The UTI associated with catheterization was defined on the basis of bacterial and cytological criteria (>10(5)cfu bacteria per mL and >10 leucocytes per mm(3)). Twenty-two UTIs were recorded: 13 in group 1 and nine in group 2. The cumulative incidence of UTI associated with catheterization was 11.1% overall, 11.9% for group 1 and 10% for group 2; the odds ratio was 0.82 (95% confidence interval: 0.30 to 2. 20); the cumulative incidence for UTI, calculated by the Kaplan-Meier method was 36.3 overall, 35.2 in group 1 and 36.0 in group 2; the overall incidence density was 19 per thousand days of catheterization, 21 in group 1 and 18 in group 2. The differences between the two groups were not significant. Overall, we feel that there is not enough evidence to conclude that catheters coated with silver salts and hydrogel give greater protection than classical catheters and to recommend widespread use.
                Copyright 2000 The Hospital Infection Society. Urinary tract infection is one of the most common nosocomial infections in hospitalized patients. It is predominantly associated with indwelling urinary catheters.
                To determine whether nitrofurazone-impregnated urinary catheters reduce the incidence of catheter-associated bacteriuria and funguria (CABF).
                Randomized, double-blind, controlled trial.
                Copenhagen Trauma Center, Copenhagen, Denmark.
                212 consecutive adult trauma patients admitted between July 2003 and August 2005. Eligible patients needed a urinary catheter on arrival and were excluded if they were HIV positive, were pregnant, had a primary burn injury, or were receiving steroid treatment or if informed consent was unattainable. Interventions: Nitrofurazone-impregnated or standard silicone catheter throughout the duration of catheterization.
                Catheter-associated bacteriuria and funguria, defined as at least 10(3) colony-forming units/mL, was assessed daily until removal of the catheter, with a prespecified minimum of 24-hour follow-up for the primary analysis. The microbiologist was blinded to study group assignment.
                1190 urine cultures were obtained over 1001 catheter-days. Catheter-associated bacteriuria and funguria occurred less frequently in the nitrofurazone catheter group than in the silicone catheter group (7 of 77 [9.1%] vs. 19 of 77 [24.7%]; incidence per 1000 catheter-days, 13.8 vs. 38.6; adjusted risk, 0.31 [95% CI, 0.14 to 0.70]; P = 0.005). Onset of CABF was delayed in the nitrofurazone group (P = 0.01), and nitrofurazone catheters led to fewer instances of new or changed antimicrobial therapy (adjusted risk, 0.27 [CI, 0.10 to 0.69]; P = 0.006).
                The clinical significance of asymptomatic bacteriuria and funguria is unclear. Data were missing in 27% of patients, and the magnitude of effect of the nitrofurazone catheters varied by assumptions about outcomes in patients who did not complete 24-hour follow-up.
                Nitrofurazone-impregnated urinary catheters reduced the incidence of CABF in adult trauma patients, reducing the need to change or prescribe new antimicrobial therapy. ClinicalTrials.gov registration number: NCT00192985. Latex, hydrophilic polymer-coated latex and PVC balloon indwelling urethral catheters were compared in respect of the urinary tract infections arising in association with their use in male patients. The polymer (Hydron) coating conferred no benefit over uncoated latex which in turn was indistinguishable from PVC. No significant differences in the spectra of infecting organismns were observed between the 3 catheter types. We evaluated the clinical efficacy and safety of a Foley catheter coated with silver-protein (ProAg catheter) in the prevention of catheter-associated bacteriuria. ProAg catheter significantly reduced the incidence of extraluminal catheter-associated bacteriuria compared with usual latex Foley catheter although it did not inhibit intraluminal bacteriuria. There was no difference between ProAg catheter and latex catheter in the side effects such as urethral discharge, catheter-associated pain and allergic reaction. The ProAg catheter may be useful as an indwelling urethral catheter. The tendency of indwelling catheters to cause urinary tract infection was evaluated in a randomised clinical study of 223 patients. A Foley catheter coated with silver alloy on both inner and outer surfaces was used in 60 patients; 60 others received a Teflonised latex Foley's catheter and the remaining 103 patients were excluded because of antibiotic treatment, diabetes, etc. There was a statistically significant difference in the incidence of catheter-associated bacteriuria (greater than 10(5) organisms/ml) in the 2 groups after 6 days' catheterisation: 6 patients with the silver coated catheter developed bacteriuria compared with 22 who had the Teflonised latex catheter. This suggests that the silver impregnated urethral catheters reduce the incidence of catheter-associated urinary tract infection. The efficacy of nitrofurazone-coated urinary catheter in inhibitory activity of catheter-associated urinary tract infection (CAUTI) was evaluated. The incidence rate and onset of CAUTI after catheterisation of standard silicone urinary catheters and nitrofurazone-coated catheters was compared. There was no statistical significance between the two groups in the incidence rate of CAUTI. However, in patients who had indwelling urinary catheters for 5-7 days, the incidence rate of CAUTI was significantly lower in the experimental group. Logistic regression analysis showed that the two variables, including age and period of insertion, affected the incidence rate of CAUTI significantly. Nitrofurazone-coated catheters can be useful for inhibition of CAUTI in patients who have indwelling urinary catheter for 5-7 days and in old-age patients. The tendency to develop bacteriuria during the use of various forms of indwelling catheters was evaluated in a randomized trial in 90 patients. A silver alloy and hydrogel-coated Foley catheter (SHC) was compared to a non-coated catheter (NC) and a catheter coated only with hydrogel (HC). Three patients (10%) with SHC catheters, 10 (33%) patients with HC catheters, and 15 (50%) patients with NC catheters developed bacteriuria (greater than 10(5) organisms/ml). The difference in the rate of bacteriuria after 5 days of catheterization was statistically significant between the SHC catheter and the NC catheter (p less than 0.002). There was no significant difference between the SHC catheter and the HC catheter, nor was there a significant difference between the HC catheter and the NC catheter. The toxic effects, as estimated by the IC50 value, of the urinary catheter material used was elucidated in an experimental fibroblast model. The IC50 value for the NC catheter was 33.9%, HC catheter 72.2% and for the SHC catheter 98.1%.
The results suggest that the use of silver alloy indwelling catheters for catheterising hospitalised adults short-term reduces the risk of catheter associated bacteriuria. Further evaluation is required to confirm if the benefits translate clinically to a reduction in symptomatic urinary tract infection risk, and if this is cost effective considering the increased cost of silver alloy catheters. Catheters impregnated with antibiotics are also beneficial in reducing bacteriuria in hospitalised adults catheterised for less than one week but there was insufficient data to draw conclusions about those catheterised for longer. Further studies are required to assess the effects of antibiotic impregnated catheters on the risk of symptomatic urinary tract infection. There was not enough evidence to suggest whether or not any standard catheter was better than another in terms of reducing the risk of bacteriuria in hospitalised adults catheterised short-term. Siliconised catheters may be less likely to cause urethral side effects in men; however, this result should be interpreted with some caution as the trials were small and the outcome definitions and specific catheters compared varied.