Bladder Stimulation Technique for Clean Catch Urine Collection in Infants : Assessing Impact on Patients and Providers in a Pediatric Emergency Department

Previous studies have demonstrated that the bladder stimulation technique is a quick and non-invasive approach to collecting urine in young infants with a contamination rate similar to the current more invasive gold standard, catheterization. This study, however, will be the first to demonstrate the feasibility of incorporating this technique into clinical practice in a busy, urban, academic pediatric emergency department (PED). In training over 120 PED staff, the investigators aim to demonstrate that minimal training is required to perform this technique. In addition, the investigators hypothesize that the bladder stimulation technique will be well tolerated by patients, and preferred by providers and parents when compared with catheterization. The results of this study may then lead to a change in practice where the bladder stimulation technique will be used preferentially for infants requiring a urinalysis and urine culture.

Urinary tract infection (UTI) is the most common serious bacterial infection among febrile infants, occurring in 7% of children less than 24 months of age evaluated for fever without a source. The American Academy of Pediatrics (AAP) recommends obtaining a urine specimen for urinalysis and culture via suprapubic aspiration (SPA) or catheterization, particularly for infants requiring immediate antimicrobial therapy. These methods are painful and invasive, yet are considered the gold standard approaches to urine collection in infants as the culture obtained has a sensitivity and specificity of >95%. Alternative techniques, such as a urine collection bag attached to the perineum or a clean catch urine (CCU), offer non-invasive approaches to urine collection but are undesirable as cultures obtained using a bag have a false positive rate approaching 90% and CCU can be time consuming. As an alternative to these methods, Herreros et al described a new non-invasive technique for obtaining a mid-stream CCU sample in newborns. This approach couples feeding with bladder stimulation and was successful in 86% of newborns with a mean time of 57 seconds. Subsequent research has demonstrated that this technique is particularly effective for children ≤ 90 days with a contamination rate similar to that of catheterization. While previous studies have demonstrated the ease of this approach, without an increase in contamination rates compared with more invasive techniques, previous studies have relied upon trained study personnel, limiting the generalizability of the technique.

The proposed study builds upon published literature. Herreros et al first described the bladder stimulation technique in newborn infants, which was successful in 86% of newborns with a mean time of 57 seconds. Altuntas et al subsequently demonstrated in a randomized controlled study that the bladder stimulation technique was effective in 78% of newborns, with urine collection occurring within a median time of 60 seconds. Tran et al then demonstrated that this technique is particularly effective for children ≤ 90 days presenting to the emergency department with a contamination rate similar to that of catheterization. Importantly, these findings were replicated by Labrosse et al who also noted that the contamination proportion is not statistically different from the rate seen with catheterization. Thus, while all the previous studies have demonstrated the ease of this approach, without an increase in contamination rates compared with more invasive techniques, previous studies have relied upon trained study personnel, limiting the generalizability of the technique to routine clinical care.

This study will be conducted in the PED at the Children's Hospital of Michigan, an academic tertiary care facility in an inner city setting with approximately 90,000 PED visits annually.

The investigators estimate a sample size of 92 patients to be recruited over the study period. This was based on a margin of error (e=0.10) obtained from the study by Labrosse et al. The investigators estimate a success rate of 40% for the bladder stimulation technique, with a 5% level of significance (p < 0.05).