Evaluation of a new PVC-free catheter material for intermittent catheterization: a prospective, randomized, crossover study.

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.