A Comparative Randomized Crossover Pilot Study Comparing Male External Urine Collection Devices in Home Settings

PURPOSE: The purpose of this study was to compare nighttime urine capture, safety, and participant preference between a male external catheter connected to a vacuum-assisted collection system and a male condom catheter in community-dwelling older men who previously used incontinence products at night. DESIGN: Prospective, open label, randomized, 2-phase crossover pilot study. PARTICIPANTS AND SETTING: Fifteen older men (≥65 years) requiring nocturnal urine management were enrolled across 2 US outpatient research sites (Greenacres, FL; Hamilton, NJ). Data were collected March-June 2025 in participants' home setting. METHODS: Participants were randomized 1:1 to device sequence and used each device for 7 consecutive nights separated by a ≥2-day washout. Primary outcomes assessed mean nightly urine capture rate (performance) and device-related adverse events requiring medical intervention (safety). Secondary endpoints included device preference, dislodgement, and tolerability, whereas changes in the PROMIS Sleep Disturbance scale before and after the use of each device were captured as exploratory endpoints. Analyses were descriptive with paired comparisons and beta regression for capture rate. RESULTS: Fifteen participants completed both 7 night usage periods. Mean (SD) overall capture rate was 98.5% (1.7) with the study device (MEC) versus 98.1% (2.6) with the comparator (sheath; LS mean difference 0.5%, 95% CI -0.8 to 1.7). No device-related adverse events requiring medical intervention were reported. Device dislodgement occurred infrequently for both devices and was numerically higher for the male external catheter, with events primarily occurring during the first treatment phase and driven by repeated dislodgements in a single participant. Preference favored the study device (13/15, 86.7%). The PROMIS Sleep Disturbance scale decreased (improved) from baseline in both periods (mean change -8.6 and -6.3). CONCLUSIONS: In older men requiring nocturnal urine management at home, the male external urine collection device demonstrated capture performance and safety comparable to a sheath-style catheter, with strong participant preference for the external collection device.