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A tolerability and patient acceptability pilot study of a novel antimicrobial urinary catheter for long-term use

Belfield, Katherine; Betts, Helen; Parkinson, Richard; Bayston, Roger

A tolerability and patient acceptability pilot study of a novel antimicrobial urinary catheter for long-term use Thumbnail


Authors

Dr KATIE BELFIELD Katie.Belfield@nottingham.ac.uk
Senior Research Strategy and Performance Manager

Helen Betts

Richard Parkinson

Roger Bayston



Abstract

© 2018 Wiley Periodicals, Inc. Aims: 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. Methods: 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. Results: 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. Conclusions: 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.

Citation

Belfield, K., Betts, H., Parkinson, R., & Bayston, R. (2018). A tolerability and patient acceptability pilot study of a novel antimicrobial urinary catheter for long-term use. Neurourology and Urodynamics, 38(1), 338-345. https://doi.org/10.1002/nau.23858

Journal Article Type Article
Acceptance Date Sep 23, 2018
Online Publication Date Oct 23, 2018
Publication Date Dec 28, 2018
Deposit Date Sep 24, 2018
Publicly Available Date Oct 24, 2019
Journal Neurourology and Urodynamics
Print ISSN 0733-2467
Electronic ISSN 1520-6777
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 38
Issue 1
Pages 338-345
DOI https://doi.org/10.1002/nau.23858
Keywords anti‐infective agents; catheter‐related urinary tract infections; clinical trial; safety; urinary catheters
Public URL https://nottingham-repository.worktribe.com/output/1129307
Publisher URL https://onlinelibrary.wiley.com/doi/abs/10.1002/nau.23858
Additional Information This is the peer reviewed version of the following article: Belfield K, Betts H, Parkinson R, Bayston R. A tolerability and patient acceptability pilot study of a novel antimicrobial urinary catheter for long‐term use. Neurourology and Urodynamics. 2019;38:338–345, which has been published in final form at https://doi.org/10.1002/nau.23858. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions.
Contract Date Sep 24, 2018

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