title: Evaluation of a new PVC-free catheter material for intermittent catheterization: a prospective, randomized, crossover study.
abstract: 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.
  
  
  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.
authors: Urologcentrum Borås, Borås, Sweden. kerstin@urolog.nu
authors: Kerstin
authors: K
authors: Johansson
authors: Gunvor
authors: G
authors: Greis
authors: Birgit
authors: B
authors: Johansson
authors: Agneta
authors: A
authors: Grundtmann
authors: Yvonne
authors: Y
authors: Pahlby
authors: Solveig
authors: S
authors: Törn
authors: Hanna
authors: H
authors: Axelberg
authors: Petrea
authors: P
authors: Carlsson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D010146:Pain / Q000453:epidemiology; D017060:Patient Satisfaction; D011143:Polyvinyl Chloride / Q000009:adverse effects; D011446:Prospective Studies; D014546:Urinary Catheterization / Q000295:instrumentation*; D062885:Urinary Catheters / Q000009:adverse effects*
chemical_list: D011143:Polyvinyl Chloride