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

Abstract

Objective: To evaluate the performance of a new 30-cm-long, telescoping male intermittent catheter (SpeediCath Compact Male; Coloplast A/S, Humlebaek, 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.

Residual urine volumes after intermittent catheterization in men with spinal cord injury

“…Mean residual urine volumes reported by other authors range between 9 and 40 ml. [4][5][6] Notable is the wide variation in measured volumes, between 0 and 250 ml, in the present study. Nevertheless, relevant residual urine volumes 450 and 4100 ml were only observed after 6% (n ¼ 7) and 3% (n ¼ 4), respectively, of all catheterizations (n ¼ 120).…”

“…19 There was no difference in the efficiency of evacuating urine from the bladder between the various catheter types used in the present study. In two other studies, residual urine volumes after IC using short-or standard-length catheters in male 6 and female 5 SCI individuals have been investigated. There was no significant difference in residual urine volumes between the short-and standard-length catheters.…”

“…3 However, there are only sparse data on the efficiency of IC in evacuating urine from the bladder, indicating that there is some residual urine after IC in certain patients. [4][5][6] Residual urine is considered to be an important risk factor for urinary tract infections (UTIs), 7,8 and even small volumes may predispose for infections. 4 Although less frequent than with indwelling catheterization, 9,10 recurrent UTIs are a major problem affecting SCI patients with NLUTD using IC, even when applying adequate catheterization techniques.…”

Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization

“…In 2011, Domurath et al, 4 reported on a trial with the use of a 30-cm telescoping catheter which was compared with a 40-cm length standard catheter. That study reported a non-statistically significant trend toward patient preference for the shorter length catheter with no significant difference in post void residual when comparing groups by ultrasound measurement after catheterization.…”

Urethral strictures in men with neurogenic lower urinary tract dysfunction using intermittent catheterization for bladder evacuation

“…1 Bladder evacuation by IC in men with NLUTD is a safe and efficient method with minimal residual urine volumes. 2,3 The most common complication in patients using IC is lower urinary tract infection. 4 Second, occult urethral trauma as a result of repeated catheter introduction occurs regularly, especially in men, but most commonly does not have lasting consequences.…”