Randomized Crossover Trial of Single Use Hydrophilic Coated vs Multiple Use Polyvinylchloride Catheters for Intermittent Catheterization to Determine Incidence of Urinary Infection

Abstract

Purpose: Urinary tract infection is a key issue for long-term intermittent catheterization users. Various catheter designs and methods have evolved to decrease the risk but the evidence remains unclear regarding whether product type improves outcomes. We determined whether single use hydrophilic coated catheters reduced urinary tract infections compared to multiple use polyvinylchloride catheters for children with neurogenic bladder due to spina bifida.

Materials and methods: This was a randomized crossover 4-center trial with 2 treatment periods of 24 weeks each, consisting of single use hydrophilic coated catheter and multiple use polyvinylchloride catheter (washed with soap and water, and air dried after each use). Each week participants recorded symptoms and urine results (Multistix® 8SG reagent strip). Primary outcome was person-weeks of urinary tract infection, defined as positive leukocytes plus fever, flank pain, increased incontinence, malaise, or cloudy or odorous urine requiring antibiotic treatment. Individuals were included if they were a child or young adult with spina bifida and used intermittent catheterization as the primary method of bladder emptying.

Results: Calculated sample size was 97. More than 120 patients were screened, of whom 66 were randomized and 45 completed both trial arms. Mean age was 10.6 years. Of the patients 21 were male and 24 were female. Mean ± SD person-weeks of urinary tract infection was 3.42 ± 4.67 in the single use hydrophilic coated catheter group and 2.20 ± 3.23 in the multiple use polyvinylchloride catheter group (p <0.001). There were no statistical differences in weeks of febrile urinary tract infection or antibiotic use.

Conclusions: Results are consistent with the Cochrane Review in that single use hydrophilic coated catheters may not decrease the incidence of symptomatic urinary tract infection in community dwelling chronic intermittent catheterization users when compared to clean multiple use polyvinylchloride catheters.

Keywords: intermittent urethral catheterization; neurogenic; spinal dysraphism; urinary bladder; urinary tract infections.