Randomized Clinical Trial Using Sterile Single Use and Reused Polyvinylchloride Catheters for Intermittent Catheterization with a Clean Technique in Spina Bifida Cases: Short-Term Urinary Tract Infection Outcomes.

Abstract

Urinary tract infections are common and severe complications in patients with spina bifida. Management includes intermittent bladder catheterization with single use or reused sterile catheters. There is insufficient evidence to set a standard among the different techniques. We determined whether single use polyvinylchloride catheters would reduce urinary tract infections compared to reused polyvinylchloride catheters in patients with neurogenic bladder due to spina bifida. We performed a 2-arm randomized parallel clinical trial from 2015 to 2016 with an 8-week followup at our center in patients with neurogenic bladder caused by spina bifida. Patients were divided into single use and reused polyvinylchloride catheter groups. Evaluations were done on days 0, 7, 14, 28, 42 and 56. Participants reported symptoms and urine cultures were obtained. The primary outcome was urinary tract infection frequency, defined as positive urine culture plus fever, flank pain, malaise, or cloudy or odorous urine. Study eligibility criteria were age 2 years or greater, spina bifida diagnosis with regular clean intermittent bladder catheterization and no urinary tract infection at initial evaluation. The calculated sample size was 75. Of the patients 135 were screened, 83 were randomized and 75 completed followup. Mean age was 12.7 years (range 2-56) and there were 29 males and 46 females. No statistical difference was found between the single use vs reused catheter groups in the frequency of asymptomatic bacteriuria (32.4% vs 23.7%, p = 0.398) or urinary tract infections (35.2% vs 36.8%, p = 0.877). Single use polyvinylchloride catheters for intermittent bladder catheterization did not decrease the incidence of urinary tract infections in our patients with neurogenic bladder compared to reused polyvinylchloride catheters. These results are consistent with the 2014 Cochrane Review.