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

ABSTRACT: 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.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.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.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.

SUBMITTER: Johansson K

PROVIDER: S-EPMC3549608 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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

Johansson Kerstin K Greis Gunvor G Johansson Birgit B Grundtmann Agneta A Pahlby Yvonne Y Törn Solveig S Axelberg Hanna H Carlsson Petrea P

Scandinavian journal of urology 20120705 1

<h4>Objective</h4>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.<h4>Material and methods</h4>This was a prospective, randomized, crossover study in 104 male patients with maintained urethra sensibility who p ...[more]

PMID: 22762536

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Project description:BackgroundSystematic reviews have highlighted the lack of evidence on choosing the type of intermittent urinary catheter (IUC) with regard to the occurrence of urinary tract infections (UTIs).ObjectiveTo describe the incidence and frequency of symptoms suggestive of UTIs (ssUTIs) for prelubricated versus hydrophilic IUCs.Design setting and participantsAn observational study of a patient database compiled by UK general practitioners was conducted.Outcome measurements and statistical analysisThe primary outcome measures were the proportion of patients with at least one ssUTI (prescription of a nonspecific antibiotic with a UTI-related diagnosis, or prescription of a UTI-specific antibiotic) and the mean number of ssUTIs per affected patient in the 12 mo following the index IUC prescription. Comparable prelubricated ("PRELUBE") and hydrophilic ("HYDRO") catheter groups were obtained with 1:1 propensity score matching (PSM).Results and limitationsA total of 5296 patients were included (prelubricated: n = 458; hydrophilic: n = 4838). After PSM, the two groups had similar proportions of patients with ssUTIs at baseline. The proportion of patients with ssUTIs during exposure was similar in the PRELUBE (36.9%) and HYDRO groups (41.5%; p = 0.155). However, among patients having used the same type of catheter throughout the exposure period, the proportion with ssUTIs was significantly lower in the PRELUBE group (44.6%, vs 55.0% for HYDRO; p = 0.015), as was the number of ssUTIs per patient (1.3 vs 1.8; p = 0.036).ConclusionsWhen choosing a coated IUC, physicians and patients should not rule out PRELUBE IUCs for safety reasons alone.Patient summaryUsing real-world data compiled by UK general practitioners, we described the incidence and frequency of symptoms suggestive of urinary tract infection in people who were using various types of intermittent urinary catheters. When the same type of prelubricated catheter was used throughout the study period, the incidence of these symptoms was lower than for hydrophilic catheters.

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

Publications

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

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