Decolonization potential of 0.02% polyhexanide irrigation solution in urethral catheters under practice-like in vitro conditions

Abstract

BackgroundLong-term use of indwelling urethral catheters is associated with high risk of urinary tract infection (UTI) and blockage, which may in turn cause significant morbidity and reduce the life of the catheter. A 0.02% polyhexanide irrigation solution has been developed for routine mechanical rinsing together with bacterial decolonization of suprapubic and indwelling urethral catheters.MethodsUsing a practice-like in vitro assay and standard silicon catheters, artificially contaminated with clinically relevant bacteria, experiments were carried out to evaluate the bacterial decolonization potential of polyhexanide vs. 1) no intervention (standard approach) and 2) irrigation with a saline (NaCl 0.9%) solution. Swabbing and irrigation was used to extract the bacteria.ResultsIrrigation with polyhexanide reduced the microbial population vs. the control catheters by a factor of 1.64 log10 (swab extraction) and by a factor of 2.56 log10 (membrane filtration). The difference in mean microbial counts between the two groups (0.90) was statistically significant in favor of polyhexanide when the liquid extraction method was used (p = 0.034). The difference between the two groups using the swab extraction method did not reach statistical significance.ConclusionsThe saline and polyhexanide solutions are able to reduce bacterial load of catheters, which shows a combined mechanical and antimicrobial effect. Further research is required to evaluate the long-term tolerability and efficacy of polyhexanide in clinical practice.

Tolerability And Safety Of Urotainer® Polihexanide 0.02% In Long-Term Catheterized Patients: A Prospective Cohort Study

“…Although the foreseen number of participants has not been reached, the data from this study, combined with the clinical and preclinical data available for polihexanide, demonstrate sufficient evidence that the substance can safely be used for catheter irrigation. An initial in vitro study using a polihexanide solution in bladder catheters has already demonstrated bactericidal activity, leading to bacterial decolonization of the catheters (22). Future studies should evaluate its clinical effectiveness in patients with long-term indwelling catheters.…”

“…Among the 28 reported AEs, 22 (78.6%) were classified as Adverse Device Effects (ADEs). For these 22 ADEs, the association between the AEs and the medical device was classified as possible (n = 16;…”

Biofilm prevention potential of 0.02% polyhexanide irrigation solution in urethral catheters under practice-like in vitro conditions

“…Medical devices such as suprapubic and indwelling catheters used in clinical settings are frequently colonized by bio lms of a variety of microbial species with detrimental consequences for the patients (13). Research is focused on decolonization of urethral catheters via treatment with a range of systemic antibiotic regimens (14) even though antibiotic resistance and drug adsorption are heavily modi ed in bio lms (4,6,13). In fact, antimicrobial compounds are usually not able to penetrate the full depth of the microbial bio lms, reducing the available options for effective therapy (15).…”

“…Pathogens such as Escherichia coli, Enterobacter spp., Pseudomonas spp., Enterococcus spp., Staphylococcus aureus, coagulase-negative staphylococci and yeasts are common causes of urinary tract infections and catheter blockage (4,6) and the most commonly reported species forming bio lms on urethral catheters are Candida spp., Pseudomonas aeruginosa, Proteus mirabilis, E. faecalis, and S. aureus (2,4). Scanning electron microscopy performed on bio lms formed on indwelling catheters has shown depths ranging from 3 to 490 µm and up to 400 visible bacterial cells deep (5).…”

“…Polyhexanide (polyhexamethylene biguanide or PHMB) is a polymer frequently used as an antiseptic with broad antibacterial activity, good tissue tolerability and, to date, shows no development of bacterial resistance (9). Polyhexanide has been used for mechanical rinsing and removal of bio lms across a range of applications (6,8,10). In this study, we investigated the potential of a polyhexanide solution to reduce and prevent bio lm formation under practice-like in vitro conditions in arti cially colonized catheters.…”