Clinical evaluation of a newly developed catheter (SpeediCath Compact Male) in men with spinal cord injury: residual urine and user evaluation.

Objective: To evaluate the performance of a new 30-cm-long, telescoping male intermittent catheter (SpeediCath Compact Male; Coloplast A/S, Humlebæk, Denmark) in urinary bladder emptying, safety and subject acceptance vs a standard-length male intermittent catheter (SpeediCath).

Materials And Methods: In a prospective, randomized, multicenter, crossover non-inferiority study, 37 male intermittent catheter users self-catheterized three times with the test catheter on one test day and three times with the standard-length male (reference) catheter on another test day. Residual urine (RU) volume in the bladder after catheterization was measured by ultrasound. Safety was assessed in the entire study period in terms of adverse events (AEs) and adverse device events (ADEs). Subjects evaluated their experience, sensation, disposal, bleeding and discomfort with the test and reference catheters and final catheter preference.

Results: SpeediCath Compact Male did not differ from the reference catheter in terms of performance (bladder emptying). The upper confidence limit of the mean difference between absolute RU volumes for the test and reference catheter groups did not exceed a pre-established non-inferiority limit of 20  ml, thereby showing the test catheter's non-inferiority to the reference catheter (that is, no worse at bladder emptying). The only AE/ADE reported was one instance of mild urethral burning for 30  min after catheterization, which was judged possibly related to the test catheter but resolved quickly.

Conclusions: The SpeediCath Compact Male catheter is as efficient as a conventional intermittent catheter (SpeediCath) at emptying the bladder with the additional benefit of being more discreet and easier to use.