Abstract
ObjectiveThere is unmet need for an easy, noninvasive urine collection method to diagnose urinary tract infections (UTIs) in nursing home residents suffering from urinary incontinence or cognitive impairments. UTIs are highly prevalent in nursing home residents, and urine specimen collection can be difficult. The objective of this study was to assess if urine specimens collected from super-absorbing incontinence pads (adult diapers) are a reliable collection method for UTI diagnosis. DesignThis was a paired noninferiority laboratory study, in which pairing refers to UTI diagnostics performed directly using clinical urine specimens (reference specimen) and indirectly using urine extracted from diapers (diaper specimen). Setting and participantsIn this study, remnants of 250 clinical urine specimens were used to assess noninferiority in diagnosing UTIs, based on a 1-sided type I error of 2.5%, a power of 90%, and a noninferiority margin of 15%. MethodsUrine specimens were poured on super-absorbing disposable adult diapers and extracted after 3 hours, to use for dipstick urinalysis and bacterial culture. UTIs were defined as presence of leukocytes and a positive bacterial culture. Noninferiority was assessed by calculating a Wald-type test statistic. ResultsNoninferiority was established for diagnosing UTIs in diaper specimens, and for each of its components (dipstick leukocyte detection and bacterial culture positivity). Positive bacterial cultures were found in 72 (29.0%) diaper specimens compared with 65 (26.2%) reference specimens (difference −2.8%, 97.5% CI −7.1% to 1.5%). Leukocytes were present in 162 (64.8%) diaper specimens, compared with 175 (70.0%) reference specimens (difference −5.7%, 97.5% CI: −10.6% to −0.7%). Conclusion and implicationsOur results on diagnosing UTIs, by dipstick analysis and bacterial cultures, using super-absorbing adult diapers are promising. Before translation into clinical practice, further studies are needed to evaluate the risk of bacterial contamination by wearing adult diapers, possibly resulting in overdiagnosis of UTI.
Highlights
The primary outcome of this study was defined as the frequency of urinary tract infections (UTIs) in diaper specimens compared with reference specimens, defined as the presence of any leukocytes AND the presence of uropathogen(s) at !104 colony-forming units (CFU)/mL
The absence or presence of leukocytes in both diaper and reference specimens was defined as agreement, as from a clinical perspective, distinguishing the absence and presence of leukocytes is more relevant than determining the number of leukocytes in urine
For the UTI definition, a uniform growth cutoff of !104 CFU/mL was used for all uropathogens, as determinants of cutoff levels were unknown.[8]
Summary
There is unmet need for an easy, noninvasive urine collection method to diagnose urinary tract infections (UTIs) in nursing home residents suffering from urinary incontinence or cognitive impairments. Disposable super-absorbing urine incontinence pads (referred to as adult diapers in the following) could potentially provide a noninvasive alternative to collect urine specimens for UTI diagnostics in older nursing home residents. There are 2 small clinical studies in older adults that investigated the use of adult diaper specimens to diagnose UTI These results are encouraging, with good agreement in bacteriological cultures and dipstick results but difficult to extrapolate, because they either used outdated methods (leukocyte microscopy rather than dipstick test and nonegel-based adult diapers). The objective of this study was to evaluate if urine extracted from super-absorbing gel-based adult diapers is reliable as a diagnostic specimen for dipstick urinalysis and bacterial culture for UTI diagnostics
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