Safety, usability, patient comfort, and exploratory biofilm outcomes of the superhydrophilic antifouling LubriShield(R) Foley catheter: a randomised controlled trial
- 1CytaCoat AB, Solna, Sweden
Abstract
BackgroundIndwelling urinary catheters can cause pain, urethral irritation and trauma and provide surfaces for microbial colonisation and biofilm formation. The LubriShield(R) Foley catheter incorporates a covalently bonded, superhydrophilic antifouling hydrogel designed to reduce surface friction and limit biofilm accumulation without releasing an antimicrobial agent. This study evaluated its safety and clinical performance compared with an uncoated silicone Foley catheter, including usability and patient comfort, and explored catheter-associated microbial colonisation and biofilm formation.
MethodsThis prospective, randomised, single-blind, single-centre controlled clinical investigation enrolled 33 adults requiring indwelling urinary catheterisation for 72 hours to 14 days. Participants received either the LubriShield(R) Foley catheter (n = 16) or an uncoated Sterimed all-silicone Foley catheter (n = 17). The primary endpoint was safety based on adverse-event reporting; the prespecified safety criterion was the absence of a serious adverse device effect in the LubriShield(R) group. Secondary endpoints included investigator-rated ease and functionality of catheter insertion and removal and participant-reported pain and irritation/discomfort assessed using 0-10 numerical rating scales. Urine microbiology, catheter colonisation and catheter-level biofilm measurements were exploratory endpoints. Analyses were performed in the as-treated population. Numerical rating scale outcomes were compared using two-sided Mann-Whitney U tests; exploratory biofilm analyses used permutation tests with bootstrap confidence intervals.
ResultsNo serious adverse events or serious adverse device effects occurred. Nine non-serious adverse events were reported and resolved completely. At least one adverse event occurred in 4/16 (25.0%) participants in the LubriShield(R) group and 4/17 (23.5%) participants in the control group. The prespecified safety criterion, defined as the absence of a SADE in the LubriShield(R) group, was met. LubriShield(R) was rated more favourably for ease of insertion (p = 0.0096), functionality during insertion (p = 0.0051), ease of removal (p = 0.0037) and functionality during removal (p = 0.0085). Participants reported significantly less pain and irritation/discomfort during insertion, while the catheter was indwelling and during removal (all p < 0.05). Outcomes 7 {+/-} 1 days after catheter removal were similar between groups. Absolute biofilm biomass and bacterial and fungal loads did not differ significantly. In a post hoc exploratory normalised analysis, the biofilm-to-bacterial-load ratio was lower with LubriShield(R) (median 0.052 vs 0.080; permutation p = 0.043), although the bootstrap 95% confidence interval for the between-group difference included zero.
ConclusionsThe LubriShield(R) Foley catheter demonstrated a favourable short-term safety profile and was associated with improved investigator-rated usability and participant-reported comfort compared with an uncoated silicone Foley catheter. A post hoc exploratory analysis was compatible with reduced biofilm accumulation relative to bacterial load, but this finding is hypothesis-generating only and requires confirmation in larger, adequately powered studies with prespecified biofilm endpoints.
Trial registrationClinical Trials Registry-India (CTRI), CTRI/2025/05/086528, prospectively registered on 7 May 2025, before participant enrolment. Subsequently registered with ClinicalTrials.gov, NCT07070921.
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BibTeX
@misc{romero2026safety,
title = {{Safety, usability, patient comfort, and exploratory biofilm outcomes of the superhydrophilic antifouling LubriShield(R) Foley catheter: a randomised controlled trial}},
author = {A. I. Romero and S. Madhusudhan and M. Krishnakumar and R. Sambasivam and S. Surkov and P. Wirsen and L. Bergström and G. Brookes and K. Leire and J. Andersson},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.29.26364294},
url = {https://www.medrxiv.org/content/10.64898/2026.09.29.26364294v1},
note = {CC BY-NC},
}
RIS
TY - UNPB
TI - Safety, usability, patient comfort, and exploratory biofilm outcomes of the superhydrophilic antifouling LubriShield(R) Foley catheter: a randomised controlled trial
AU - A. I. Romero
AU - S. Madhusudhan
AU - M. Krishnakumar
AU - R. Sambasivam
AU - S. Surkov
AU - P. Wirsen
AU - L. Bergström
AU - G. Brookes
AU - K. Leire
AU - J. Andersson
PY - 2026
DA - 2026/09/29
PB - medRxiv
DO - 10.64898/2026.09.29.26364294
UR - https://www.medrxiv.org/content/10.64898/2026.09.29.26364294v1
AB - BackgroundIndwelling urinary catheters can cause pain, urethral irritation and trauma and provide surfaces for microbial colonisation and biofilm formation. The LubriShield(R) Foley catheter incorporates a covalently bonded, superhydrophilic antifouling hydrogel designed to reduce surface friction and limit biofilm accumulation without releasing an antimicrobial agent. This study evaluated its safety and clinical performance compared with an uncoated silicone Foley catheter, including usability and patient comfort, and explored catheter-associated microbial colonisation and biofilm formation. MethodsThis prospective, randomised, single-blind, single-centre controlled clinical investigation enrolled 33 adults requiring indwelling urinary catheterisation for 72 hours to 14 days. Participants received either the LubriShield(R) Foley catheter (n = 16) or an uncoated Sterimed all-silicone Foley catheter (n = 17). The primary endpoint was safety based on adverse-event reporting; the prespecified safety criterion was the absence of a serious adverse device effect in the LubriShield(R) group. Secondary endpoints included investigator-rated ease and functionality of catheter insertion and removal and participant-reported pain and irritation/discomfort assessed using 0-10 numerical rating scales. Urine microbiology, catheter colonisation and catheter-level biofilm measurements were exploratory endpoints. Analyses were performed in the as-treated population. Numerical rating scale outcomes were compared using two-sided Mann-Whitney U tests; exploratory biofilm analyses used permutation tests with bootstrap confidence intervals. ResultsNo serious adverse events or serious adverse device effects occurred. Nine non-serious adverse events were reported and resolved completely. At least one adverse event occurred in 4/16 (25.0%) participants in the LubriShield(R) group and 4/17 (23.5%) participants in the control group. The prespecified safety criterion, defined as the absence of a SADE in the LubriShield(R) group, was met. LubriShield(R) was rated more favourably for ease of insertion (p = 0.0096), functionality during insertion (p = 0.0051), ease of removal (p = 0.0037) and functionality during removal (p = 0.0085). Participants reported significantly less pain and irritation/discomfort during insertion, while the catheter was indwelling and during removal (all p < 0.05). Outcomes 7 {+/-} 1 days after catheter removal were similar between groups. Absolute biofilm biomass and bacterial and fungal loads did not differ significantly. In a post hoc exploratory normalised analysis, the biofilm-to-bacterial-load ratio was lower with LubriShield(R) (median 0.052 vs 0.080; permutation p = 0.043), although the bootstrap 95% confidence interval for the between-group difference included zero. ConclusionsThe LubriShield(R) Foley catheter demonstrated a favourable short-term safety profile and was associated with improved investigator-rated usability and participant-reported comfort compared with an uncoated silicone Foley catheter. A post hoc exploratory analysis was compatible with reduced biofilm accumulation relative to bacterial load, but this finding is hypothesis-generating only and requires confirmation in larger, adequately powered studies with prespecified biofilm endpoints. Trial registrationClinical Trials Registry-India (CTRI), CTRI/2025/05/086528, prospectively registered on 7 May 2025, before participant enrolment. Subsequently registered with ClinicalTrials.gov, NCT07070921.
ER -