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

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