Safety of a New Compact Male Intermittent Catheter: Randomized, Cross-Over, Single-Blind Study in Healthy Male Volunteers

Abstract

Introduction: A new compact male intermittent catheter was compared with a regular intermittent male catheter in terms of safety and acceptability. Methods: In this randomized, single-blind, cross-over study, healthy male volunteers were catheterized twice with a compact catheter and twice with a regular catheter. Results: 28 participants were enrolled. Mean ± SD discomfort (visual analogue scale; primary objective) was 2.25 ± 1.5 and 2.52 ± 1.8 for the compact and regular catheters, respectively (difference –0.27; 95% confidence interval –0.73 to 0.19); there was no significant difference in hematuria (p = 0.54) or discomfort/stinging/pain at first micturition (p = 0.56). During insertion, handling was easier (p = 0.0001) and touching the coating was necessary less often (2.2 vs. 81.3% of catheterizations; p < 0.0001) with the compact catheter; it was preferred by nurses for 20 of 23 participants. No adverse events were reported. Conclusions: Short-term safety of the new compact catheter was at least as good as that of the regular male intermittent catheter and handling was improved.

Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study

“…Although it is a subjective measure, it has been used successfully in other clinical trials comparing catheters. 12,14 The non-inferiority demonstrated in this trial is therefore a key clinically relevant result, together with the lack of any additional pain, resistance or stinging. This is important, as other results described here suggest that the compact catheter may have other advantages over the standard catheter.…”

“…12,15 In particular, a study in healthy volunteers by Bagi et al 12 comparing standard and compact catheters has shown no difference in discomfort, stinging or pain between the two catheters. Another study in women with a similar compact catheter also found that it was at least as efficient at emptying the bladder as more conventional female catheters.…”

“…Preliminary investigations in healthy male volunteers have suggested that the short-term safety profile of this compact catheter is at least as good as a standard-sized catheter, but that the compact catheter has better handling qualities. 12 However, as catheterisation can be a long-term technique, often required for the lifetime of an individual, the longer-term safety profile and ease of use of the compact catheter needed to be confirmed in individuals with neurogenic bladder dysfunction using the catheter on a daily basis. The objective of this study was to evaluate whether the compact catheter was no less accepted than a standard catheter when used at least four times a day for 14 days by individuals with neurogenic bladder dysfunction and normal or impaired sensation in the urethra.…”

Improved Performance With the Micro-Hole Zone Intermittent Catheter

“…Mean discomfort ratings were generally low for all participants (<2.5 cm) and independent of catheter type. In the literature, the mean or median VAS scoring is generally in the 0-to 3-cm range [32][33][34][35] where previous IC experience, pain anticipation, and type of catheter (coated vs uncoated) are some factors that seem to affect VAS discomfort ratings. Therefore, higher discomfort rating in HV compared to IC users in the current studies was expected and correlates with a study by Girotti and colleagues 36 where adjustment to IC affected the mean VAS scoring scale for discomfort over time from 3.7 cm at 3 months to 2.5 cm at 6 months was reported.…”