Improved emptying performance with a new micro‐hole zone catheter in adult male intermittent catheter users: A comparative multi‐center randomized controlled cross‐over study

Aims To confirm the improved performance of the micro‐hole zone catheter (MHZC) compared to a conventional eyelet catheter (CEC) in male users of clean intermittent catheterizations (CICs). Methods Male self‐catheterizing subjects, who used hydrophilic sleeved soft/flexible CIC as the only bladder emptying method, were enrolled into a multi‐center, randomized, cross‐over study performed across six European sites. Subjects tested the MHZC, featuring a drainage zone with 120 micro‐holes and a CEC with two eyelets. The study consisted of four study visits (V0–V3), during which endpoints related to catheter performance (urinary flow‐stops, bladder emptying, and intra‐catheter pressure) were measured and two 4‐week test periods at home (T1 and T2) where dipstick hematuria and user perception between catheters were evaluated. Results Seventy‐three male subjects with non‐neurogenic and neurogenic bladder dysfunction (3:2) were enrolled. On average, catheterizations with the MHZC led to close to mean zero flow‐stops compared to ≥1 flow‐stops with the CEC, during both HCP‐ and self‐led catheterizations (both p