A Comparative Randomized Cross-Over Trial to Examine Efficacy of Urine Capture and Comfort of Two Male External Urine Collection Devices in Healthy Male Volunteers

PURPOSEThis study assessed the efficiency of urine collection using external urine collection devices over two voids in a group of morbidly obese and non-obese men.DESIGNProspective single-blind comparative crossover study.MATERIALS AND METHODWe assessed the comparative urine capture efficiency of two commercially available male external urine management systems. Continent consenting men were randomized to use each device for a single void. The proportion of urine captured by each device expressed as a percentage of the total volume voided in grams was calculated and compared. Results were compared between morbidly obese (BMI >= 40 kg/m2) and non-morbidity (BMI <= 40 kg/m2) men.RESULTSFifty-nine men completed the study; their mean (standard deviation, SD) age was 40.8 (SD 12.4) years. For void 1, the mean proportion of urine capture for Device A was 97.8% (SD 10.0); for Device B it was 90.7% (SD 20.7). For void 2, the mean proportion of urine capture for Device A was 91.1% (SD 25.8); for Device B it was 85.2% (SD 21.7). The mean difference between devices was 6.6% (95% CI 0.18, 13.0), P = .044. Stratified by weight, in the morbidly obese men, Device A captured 99.7% (SD 0.88) of the first void versus 83.5% (SD 32.2) for Device B. Analysis of the second voids found that Device A captured 80.8% (SD 36.9) versus 79.3% (SD 23.3) for Device B.CONCLUSIONDevice A (the investigational device) performed significantly better than Device B in capture rates when compared based on voided volume, order of void, or BMI category. Device A male external catheter system is an effective option for urine management in both obese and non-obese men.