Abstract
We have developed a novel antimicrobial urinary catheter (AUC) impregnated with rifampicin, triclosan, and sparfloxacin and demonstrated that it has long-term (∼84 days) protection against bacterial colonization in vitro. This study aimed to assess the safety and patient acceptability of this device in long-term catheter users. Adults who use long term (>28 days) indwelling urinary catheters with capacity to consent were invited to receive the AUC at their next catheter change. The primary outcome measure was adverse events (AE) attributable to antimicrobial impregnation of the catheter. Secondary outcome measures included severity of related AEs, patient acceptability, early removal of the trial catheter, and degree of microbial colonization of trial catheters. Except for the last, outcomes were assessed by telephone interviews. Original and trial catheters were collected, and the lumens and balloons were separated and analyzed for microbiological colonization. Thirty participants were recruited. Eighty four AEs were reported, and only one was rated as "probably" related to antimicrobial impregnation. The AE was mild and resolved within 48 h. A total of 82.14% of participants rated the catheter as no different or better than their usual catheter. Two participants chose to remove the AUC early due to it feeling shorter. There were significantly fewer bacterial isolates attached to the balloons of trial catheters compared to the matched original catheters. The AUC has an advantageous safety profile and was acceptable to the majority of participants. Information gained from this trial will support a larger randomized controlled study of efficacy.
Highlights
Catheter-associated urinary tract infections (CAUTI) are costly for health care systems as well as distressing for those who suffer from repeated infections and blockages.Long-term indwelling catheter users, who require catheterisation for over 28 days, are at risk of CAUTI 1
We have previously developed a silicone urinary catheters impregnated, not coated, with rifampicin, sparfloxacin, and triclosan and demonstrated seven to 12 weeks of protective activity against colonisation by major uropathogens, including multi-drug resistant strains[3]
In light of the discomfort experienced with the nitrofurantoin-coated catheter, this study aims to understand primarily the tolerability of this novel antimicrobial urinary catheter (AUC) in the target patient population
Summary
Adults who use longterm (>28days) indwelling urinary catheters with capacity to consent. Fo were invited to receive the AUC at their catheter change. The primary outcome measure was adverse events (AE) attributable to antimicrobial impregnation of the catheter. Secondary outcome measures included severity of related AEs, patient acceptability, early removal of the trial catheter, and degree of microbial colonisation of trial catheters. Except for the last, outcomes were assessed by telephone interviews. Original and trial catheters were collected, and the lumens and balloons were separated and analysed for microbiological colonisation
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