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

Abstract

Study design: Self-catheterising males aged X18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial. Objectives: When possible, intermittent catheterisation is the preferred method of bladder emptying for neurogenic bladder dysfunction. Hydrophilic-coated catheters have improved safety and ease of use, and a new compact catheter for men has been developed to improve discretion. Methods: Participants self-catheterised at least four times daily for 14 days with a standard or compact catheter. The primary outcome measure was discomfort, using a visual analogue scale. Non-inferiority was defined as a difference in mean discomfort score of o0.9 cm. Other assessments included ease of use, discretion and the degree of pain, stinging or resistance. Results: A total of 36 individuals participated and 30 were included in the intention-to-treat analysis. The mean difference between catheters for participant discomfort was À0.347 cm (95% confidence intervals: À1.493, 0.800). There were significant differences (Pp0.0001) in favour of the compact catheter for disposal and discretion, and inserting, storing, carrying and controlling the catheter. Fewer participants experienced resistance with the compact catheter. Participants were less likely to touch the coated part of the compact catheter. One adverse event was reported for each catheter. Conclusions: The coated compact catheter is at least as acceptable to the user as the standard catheter, with no inferiority observed in the level of discomfort. Secondary endpoints suggest that there are advantages of using the compact catheter, particularly with regard to discretion and ease of use.

Evaluation of a new PVC-free catheter material for intermittent catheterization: A prospective, randomized, crossover study

“…demographic and baseline characteristics were considered representative for the target population, and it was concluded that the study population was homogeneous. For instance, in contrast to a previously reported tolerability study [16], all patients had maintained urethra sensibility, which is considered essential for obtaining valid subjective evaluations of a catheter material. All comparisons used paired data with the subjects as their own controls, which further minimized the risk of confounding factors.…”

Outcome comparison of different approaches to self-intermittent catheterization in neurogenic patients: a systematic review

“…Spinu 2012 (NRS) (38) Vapnek 2003 (RCT) (24) De Ridder 2005 (RCT) (25) Pachler 1999 (RCT) (17) Cardenas and Hoffman 2009 (RCT) (36) Bennett 1997 (RCT) (16) Cardenas 2011 (RCT) (30) Fingerhut 1997 (RCT) (14) Charbonneau-Smith 1993 (NRS) (39) Moore 2006 (RCT) (26) Quigley PA 1993 (RCT) (12) Duffy LM 1995 (RCT) (13) Sùrensen 1999 (RCT) (18) Mauroy 2001 (RCT) (20) BIERING-SØRENSEN 2007 (RCT) (29) Costa 2013 (RCT) (33) Chartier-Kastler 2013 (RCT) (34) Chartier-Kastler 2011 (RCT) (31) Domurath 2011 (RCT) (32) Johansen 2007(NRS) (40) Johansson 2013 (RCT) (35) Denys 2012 (NRS) (41) Diokno 1995 (NRS) (42) Fader 2001 (RCT) (21) Pascoe 2001 (RCT) (22) Witjes 2009 (RCT) (37) Wyndaele 2000 (RCT) (19) Ginnantoni 2001 (RCT) (23) Waller 1997 (RCT) (15) PEARMAN 1991(RCT) (11) Sekiguchi et al 2007 (RCT) (28) 0% 20% 40% 60% 80% 100%…”

“…Five RCTs compared compact hydrophilic with standard hydrophilic catheters in terms of satisfaction and/or quality of life (Table 3a). 29,[31][32][33][34] Only one article demonstrated a significant increase in satisfaction reported from patients using a compact hydrophilic catheter, when compared with patients using a standard hydrophilic catheter. 34 Chartier-Kastler et al, 34 conducted a prospective randomized crossover study to compare compact with standard catheters in terms of quality of life.…”