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

The study included 15 men and was designed as a pilot, so it did not test whether one device was better than the other. One of 16 evaluated men was not enrolled because he was unwilling to comply. No rare adverse events were expected because the sample was small and follow-up was only 7 nights per device. The higher dislodgement rate with the suction-assisted device was driven by repeated events in one participant with significant nocturnal polyuria. The study did not allow self-emptying of the canister on nights when a nurse came in the morning, so overflow-related leakage may not reflect all home-care routines. Participants were older men able to consent and were excluded for bowel incontinence, active urogenital infection, urinary retention, genital or sacral skin breakdown, agitation, or significant cognitive impairment, so results do not apply to those groups. Preference and sleep outcomes were secondary or exploratory, and no adjustments were made for multiple comparisons. The sample was mainly Hispanic or Latino and recruited from existing patient lists, so generalizability to other populations is uncertain.

The study sponsor generated the randomization list. The devices evaluated were Becton Dickinson products. No funding or conflict-of-interest declaration appears in the supplied text.

Do not conclude that the suction-assisted device is better because most men preferred it. Preference was a secondary outcome, the study did not perform formal hypothesis testing, and the device had numerically more dislodgements, all driven by one participant.