Evaluation of a New PVC-free Catheter Material for Intermittent Catheterization: a Prospective, Randomized, Crossover Study
Overview
Authors
Affiliations
Objective: Polyvinyl chloride (PVC) is commonly used as a catheter material in catheters for clean intermittent catheterization (CIC) but, owing mainly to environmental concerns, a PVC-free material has been proposed. The objective of this study was to compare patients' tolerability for catheters made of PVC and a newly developed PVC-free material.
Material And Methods: This was a prospective, randomized, crossover study in 104 male patients with maintained urethra sensibility who practised CIC. The patients evaluated in a randomized order a PVC and a PVC-free LoFric® catheter after 1 week's use of each. The material properties and tolerability, i.e. reported perceived discomfort, of each catheter were compared and adverse events documented.
Results: Twenty-nine (28%) and 15 (14%) patients reported discomfort when using the PVC catheter and the PVC-free LoFric catheter, respectively. A comparison showed that five patients (5%) reported discomfort with the PVC-free and not with the PVC catheter, and 19 patients (18%) reported discomfort with the PVC and not with the PVC-free catheter (p = 0.0066). Forty patients reported a total of 91 adverse events, of which the most common were discomfort in terms of pain, a burning sensation and bleeding.
Conclusions: Generally low discomfort rates were reported in the study population, suggesting a high tolerance for CIC with catheters of both the PVC and the PVC-free materials. The lowest discomfort was, however, found when CIC was performed using the PVC-free LoFric catheter.
Deleanu I, Grosu E, Ficai A, Ditu L, Motelica L, Oprea O Polymers (Basel). 2024; 16(21).
PMID: 39518238 PMC: 11548089. DOI: 10.3390/polym16213028.
Understanding the properties of intermittent catheters to inform future development.
Moore J, Burns J, McClelland N, Quinn J, McCoy C Proc Inst Mech Eng H. 2023; 238(6):713-727.
PMID: 37300485 PMC: 11318220. DOI: 10.1177/09544119231178468.
Zachariou A, Zachariou D, Kaltsas A, Giannakis I, Dimitriadis F, Douvli E J Multidiscip Healthc. 2022; 15:2571-2577.
PMID: 36388624 PMC: 9656416. DOI: 10.2147/JMDH.S387110.
User perception of a new hydrophilic-coated male urinary catheter for intermittent use.
Koeter I, Stensrod G, Hunsbedt Nilsen A, Lund R, Haslam C, De Seze M Nurs Open. 2018; 6(1):116-125.
PMID: 30534401 PMC: 6279713. DOI: 10.1002/nop2.193.
Gains in health utility associated with urinary catheter innovations.
Krassioukov A, Igawa Y, Averbeck M, Madersbacher H, Lloyd A, Bogelund M Med Devices (Auckl). 2018; 11:345-351.
PMID: 30319291 PMC: 6171519. DOI: 10.2147/MDER.S165778.