RESULTS OF A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING HYDROPHILIC TO UNCOATED CATHETERS IN CHILDREN WITH NEUROGENIC BLADDER
William R. DeFoor, Jr., MD, MPH, Elizabeth Jackson, MD, Melissa Reed, RN, Bin Zhang, PhD, Julie Denlinger, RN, Brian VanderBrink, MD, Eugene Minevich, MD, Paul Noh, MD, Curtis Sheldon, MD, Pramod Reddy, MD.
Cincinnati Children's Hospital, Cincinnati, OH, USA.
Background: Children with neurogenic bladder often require intermittent catheterization (IC). Uncoated catheters are typically chosen to initiate treatment in the United States. Complications can include false passage, strictures, hematuria, and urinary tract infections (UTI). Hydrophilic catheters have lower friction than uncoated catheters with less damage to the urethra. The purpose of this study is to compare hydrophilic to uncoated catheters in children with neurogenic bladder.
Methods: An investigator-initiated, prospective, randomized clinical trial was conducted to compare hydrophilic (LoFric®) versus uncoated catheters. IRB approval and informed consent were obtained. Catheters were supplied by the manufacturer. Inclusion criteria included children ages 2-17 with neurogenic bladder on IC. Block randomization was performed in groups of 10. Exclusion criteria included stomal stenosis, current hydrophilic catheter use, and active UTI. Patients with abdominal wall catheterizable channels were included. Baseline and end of study quality of life questionnaires were performed. Dexterity tests were performed on children performing self-catheterization using a peg test. Patients were followed for one year. Outcomes included UTI, hematuria, difficulty passing the catheter, urethral injury, and satisfaction with the catheter system. UTI's were defined as a symptomatic urine culture greater than 50K CFU of a dominant organism that required treatment with culture specific antibiotics. Data was tracked using a REDCap™ system.
Results: A total of 78 patients were enrolled in the study (37 hydrophilic, 41 uncoated control). Mean age was 13 years in both groups and 51% of both groups were female. The number of patients performing self-catheterization was similar, and there were no significant differences in dexterity scores. 8 patients withdrew from the uncoated group and 16 withdrew from the hydrophilic group. One family with 3 children in the hydrophilic group withdrew due to social reasons. The hydrophilic group overall had significantly more problems with the catheter (P<0.01), the majority being difficulty handling the catheter. Three hydrophilic patients had problems with mucus clogging. There were no differences in passing the catheter, pain, hematuria, or urethral injuries. There were 2 UTI’s in 2 hydrophilic study patients and 17 UTI’s in 7 uncoated control patients. The mean number of UTI’s was significantly higher in the uncoated group (1.7±1.8 vs. 0.3±0.5, P=0.03). The number of patients with UTI’s in the hydrophilic group went from 16% in the prior year to 5% during the study period (P=0.26). Three children in the hydrophilic group had 3 or more UTI’s in the year prior to enrollment and no infections during the study period. The patients that completed the study with hydrophilic catheters were overall pleased and many requested to continue with the same catheter after the study concluded.
Conclusions: In children with neurogenic bladder on intermittent catheterization, hydrophilic catheters may decrease the risk of urinary tract infections, presumably due to decreased urethral irritation. No differences were seen in urethral complications. Patient satisfaction is mixed with some patients being highly pleased with the catheters and others finding them difficult to handle due to the slippery coating. A multi-center study may be helpful to confirm these findings.
Back to 2016 Fall Congress