SINGLE-BLIND, RANDOMIZED, PARALLEL GROUP-STUDY OF THE BARD BIOCATH CATHETER AND A SILICONE ELASTOMER COATED CATHETER

A group of 69 community patients undergoing long-term urethral catheterisation for urinary incontinence took part in this study; 33 patients with a mean age of 70.03 years (+/- 16.6) received the Dow Corning Silastic catheter (16 F 10-ml balloon) and 36 patients with a mean age of 75.61 years (+/- 12.6) received the Bard Biocath catheter (16 F 10-ml balloon). Over a 16-week period catheters were monitored every 2 weeks and changed as necessary. The Bard Biocath catheter remained in situ for an average of 89.61 days (+/- 35.31) and the Silastic catheter remained in situ for an average of 56.7 days (+/- 38.8); this difference was statistically significant. Used catheters were analysed for encrustation scanning electron microscopy (SEM). The average time in situ for non-encrusted Biocath catheters was 83.7 days and 25.28 days for non-encrusted Silastic catheters. It was found that 70% of patients who received Biocath catheters preferred them to their previous catheters whereas only 30% of patients in the Silastic group preferred the trial catheter. The incidence of bypassing was 28% in the Biocath group and 52.8% in the Silastic group.