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.

Abstract

Purpose: This 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.

Design: Prospective single-blind comparative crossover study.

Materials and method: We 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.

Results: Fifty-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.

Conclusion: Device 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.