A prospective randomised pilot study evaluating the safety of the novel LubriShield™ Foley catheter: a permanently coated indwelling urinary catheter
DOI:
https://doi.org/10.2340/sju.v60.43994Keywords:
Lubrishield, catheter, CAUTI, urinary tract infection, coated catheterAbstract
Objective: Catheter-associated urinary tract infections (CAUTIs) are prevalent healthcare-associated infections, arising from biofilm-forming bacteria. This may be prevented by coating the catheter with an antifouling substance. The novel LubriShield™ Foley catheter is coated with a superhydrophilic surface and a covalently bonded antifouling ligand. Preclinical studies revealed that the coating established a persistent local antifouling environment, inhibiting uropathogenic bacteria from forming biofilms. No substance release has been detected from the coating. The coating achieved a 28-fold reduction in surface friction compared to an uncoated catheter. The aim of this study is to assess the clinical safety of the catheter in patients.
Materials & methods: In a prospective single-centre randomised study, 30 patients undergoing transurethral resection of bladder tumour were enrolled and randomly assigned to receive either a standard control catheter or the novel LubriShield™ catheter. Urinary cultures were obtained twice. The duration of catheterisation for the patients ranged from 3 to 24 h. The primary outcome was the assessment of device-specific adverse events (AEs). Secondary outcomes included evaluations of pain, irritation and discomfort, measured using the Numeric Rating Scale (NRS) (0–10) via a patient questionnaire.
Results: There were no serious adverse events (SAEs) or AEs reported for the coated catheters. Urinary cultures showed no significant differences between the coated and uncoated catheters. Both patients and healthcare professionals rated the NRS equally for the two types of catheters.
Conclusions: The novel-coated LubriShield™ catheter was found to be safe for short-term clinical use.
Downloads
References
Flores-Mireles AL, Walker JN, Caparon M. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015;13(5):269–284. https://doi.org/10.1038/nrmicro3432 DOI: https://doi.org/10.1038/nrmicro3432
Mancuso G, Midiri A, Gerace E. Urinary tract infections: the current scenario and future prospects. Pathogens. 2023;12(4):623. https://doi.org/10.3390/pathogens12040623 DOI: https://doi.org/10.3390/pathogens12040623
Jain P, Parada JP, David A. Overuse of the indwelling urinary tract catheter in hospitalized medical patients. Arch Intern Med. 1995;155(13):1425–1429. https://doi.org/10.1001/archinte.1995.00430130115012 DOI: https://doi.org/10.1001/archinte.1995.00430130115012
Gould CV, Umscheid CA, Agarwal RK. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010;31(4):319–326. https://doi.org/10.1086/651091 DOI: https://doi.org/10.1086/651091
Jonsson K, Emanuelsson-Loft AL, Nasic S. Urine bladder catheters in nursing home patients: a one-day point prevalence study in a Swedish county. Scand J Urol Nephrol. 2010;44(5):320–323. https://doi.org/10.3109/00365599.2010.497771 DOI: https://doi.org/10.3109/00365599.2010.497771
Pelling H, Nzakizwanayo J, Milo S, et al. Bacterial biofilm formation on indwelling urethral catheters. Lett Appl Microbiol. 2019;68(4):277–293. https://doi.org/10.1111/lam.13144 DOI: https://doi.org/10.1111/lam.13144
Stickler DJ. Clinical complications of urinary catheters caused by crystalline biofilms: something needs to be done. J Intern Med. 2014;276(2):120–129. https://doi.org/10.1111/joim.12220 DOI: https://doi.org/10.1111/joim.12220
Gauhar V, Castellani D, Teoh JY, et al. Catheter-associated urinary infections and consequences of using coated versus non-coated urethral catheters-outcomes of a systematic review and meta-analysis of randomized trials. J Clin Med. 2022;11(15):4463. https://doi.org/10.3390/jcm11154463 DOI: https://doi.org/10.3390/jcm11154463
Padhye LP, Jasemizad T, Bolan S, et al. Silver contamination and its toxicity and risk management in terrestrial and aquatic ecosystems. Sci Total Environ. 2023;871:161926. https://doi.org/10.1016/j.scitotenv.2023.161926 DOI: https://doi.org/10.1016/j.scitotenv.2023.161926
GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990–2021: a systematic analysis with forecasts to 2050. Lancet. 2024;404(10459):1199–1226.
He Z, Yang X, Wang N, et al. Anti-biofouling polymers with special surface wettability for biomedical applications. Front Bioeng Biotechnol. 2021;9:807357. https://doi.org/10.3389/fbioe.2021.807357 DOI: https://doi.org/10.3389/fbioe.2021.807357
Chen S, Li L, Zhao C. Surface hydration: principles and applications toward low-fouling/nonfouling biomaterials. Polymer. 2010;51(23):5283–5293. https://doi.org/10.1016/j.polymer.2010.08.022 DOI: https://doi.org/10.1016/j.polymer.2010.08.022
Nishimoto S, Bhushan B. Bioinspired self-cleaning surfaces with superhydrophobicity, superoleophobicity, and superhydrophilicity. RSC Adv. 2013;3(3):671–690. https://doi.org/10.1039/C2RA21260A DOI: https://doi.org/10.1039/C2RA21260A
Carniello V, Peterson BW, van der Mei HC. Physico-chemistry from initial bacterial adhesion to surface-programmed biofilm growth. Adv Colloid Interface Sci. 2018;261:1–14. https://doi.org/10.1016/j.cis.2018.10.005 DOI: https://doi.org/10.1016/j.cis.2018.10.005
Ren Y, Wang C, Chen Z. Emergent heterogeneous microenvironments in biofilms: substratum surface heterogeneity and bacterial adhesion force-sensing. FEMS Microbiol Rev. 2018;42(3):259–272. https://doi.org/10.1093/femsre/fuy001 DOI: https://doi.org/10.1093/femsre/fuy001
Nuryastuti T, Krom BP, Aman AT. Ica-expression and gentamicin susceptibility of Staphylococcus epidermidis biofilm on orthopedic implant biomaterials. J Biomed Mater Res A. 2011;96(2):365–371. https://doi.org/10.1002/jbm.a.32984 DOI: https://doi.org/10.1002/jbm.a.32984
Muszanska AK, Nejadnik MR, Chen Y. Bacterial adhesion forces with substratum surfaces and the susceptibility of biofilms to antibiotics. Antimicrob Agents Chemother. 2012;56(9):4961–4964. https://doi.org/10.1128/AAC.00431-12 DOI: https://doi.org/10.1128/AAC.00431-12
Romero AI, Surkov S, Wirsén P, et al. LubriShieldTM – a unique permanent coating for indwelling urinary catheters that impedes surface-associated uropathogens from forming biofilm. bioRxiv. 2025:2025.01.24.634505. https://doi.org/10.1101/2025.01.24.634505 DOI: https://doi.org/10.1101/2025.01.24.634505
Drelich J, Chibowski E. Superhydrophilic and superwetting surfaces: definition and mechanisms of control. Langmuir. 2010;26(24):18621–18623. https://doi.org/10.1021/la1039893 DOI: https://doi.org/10.1021/la1039893
Wilks SA, Koerfer VV, Prieto JA. Biofilm development on urinary catheters promotes the appearance of viable but nonculturable bacteria. mBio. 2021;12(2):e03584–20. https://doi.org/10.1128/mBio.03584-20 DOI: https://doi.org/10.1128/mBio.03584-20
Pocock SJ. Methods of randomization. Clinical Trials; 2013. p. 66–89. DOI: https://doi.org/10.1002/9781118793916.ch5
Thong ISK, Jensen MP, Miró J. The validity of pain intensity measures: what do the NRS, VAS, VRS, and FPS-R measure? Scand J Pain. 2018;18(1):99–107. https://doi.org/10.1515/sjpain-2018-0012 DOI: https://doi.org/10.1515/sjpain-2018-0012
Odeberg J, Wirsén A, Norberg Å, et al. A novel cysteine-linked antibacterial surface coating significantly inhibits bacterial colonization of nasal silicone prongs in a phase one pre-clinical trial. Mater Sci Eng C Mater Biol Appl. 2018;93:782–9. https://doi.org/10.1016/j.msec.2018.08.040 DOI: https://doi.org/10.1016/j.msec.2018.08.040
Vopni R, Voice A, de Riese CS. Use of antimicrobial-coated catheters in preventing catheter-associated urinary tract infections and bacteriuria: a meta-analysis for clinicians. Urol Pract. 2021;8(6):705–12. https://doi.org/10.1097/UPJ.0000000000000254 DOI: https://doi.org/10.1097/UPJ.0000000000000254
Singha P, Locklin J, Handa H. A review of the recent advances in antimicrobial coatings for urinary catheters. Acta Biomater. 2017;50:20–40. https://doi.org/10.1016/j.actbio.2016.11.070 DOI: https://doi.org/10.1016/j.actbio.2016.11.070
Dai S, Gao Y, Duan L. Recent advances in hydrogel coatings for urinary catheters. J Appl Polym Sci. 2023;140(14):e53701. https://doi.org/10.1002/app.53701 DOI: https://doi.org/10.1002/app.53701
Kai-Larsen Y, Grass S, Mody B, et al. Foley catheter with noble metal alloy coating for preventing catheter-associated urinary tract infections: a large, multi-center clinical trial. Antimicrob Resist Infect Control. 2021;10(1):40. https://doi.org/10.1186/s13756-021-00907-w DOI: https://doi.org/10.1186/s13756-021-00907-w
Pickard R, Lam T, MacLennan G, et al. Antimicrobial catheters for reduction of symptomatic urinary tract infection in adults requiring short-term catheterisation in hospital: a multicentre randomised controlled trial. Lancet. 2012;380(9857):1927–1935. https://doi.org/10.1016/S0140-6736(12)61380-4 DOI: https://doi.org/10.1016/S0140-6736(12)61380-4
Banerjee I, Robinson J, Banerjee I. Medicated foley catheters do not prevent catheter-associated urinary tract infection: a systematic review of randomized controlled trials. Cureus. 2024;16(8):e66235. https://doi.org/10.7759/cureus.66235 DOI: https://doi.org/10.7759/cureus.66235
Published
How to Cite
Issue
Section
License
Copyright (c) 2025 Anders Andreasson, Jan Andersson, Henrik Larsson, Teresa Ekerhult, Johan Stranne
This work is licensed under a Creative Commons Attribution 4.0 International License.
As from Volume 59 (2024) all published articles, unless otherwise specified, are published under CC-BY license, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, with the condition of proper attribution to the original work.
