A prospective, randomized, cross-over, multicenter study comparing quality of life using compact vs. standard catheters for intermittent self catheterization

BERKELEY, CA (UroToday.com) - This study was a non-blinded, randomized, multicenter, two-way, crossover study with two treatment periods of 6 weeks, in patients with neurogenic bladder dysfunction (n=125) who were performing intermittent self-catheterization (ISC). The majority of subjects were male (87%), had good hand dexterity (88%), and 40% were using a wheelchair. Spinal cord injury was the main cause of bladder dysfunction. Subjects had performed ISC for an average of 10.1 years. The study was conducted in 17 sites in France, Germany, Denmark, Sweden, and Norway.

The aim of the study was to compare a compact hydrophilic catheter (Coloplast) to standard hydrophilic catheters on quality of life in men or women. The catheter tested is unique as it has a hydrophilic coating and its length can be extended from 19 cm to 29.6 cm. This is referred to as a “telescopic system.” Quality of life was measured using the validated Intermittent Self-catheterization Questionnaire (ISC-Q).[1]

Of the 125 enrolled, 15 subjects discontinued the study for a variety of catheter-related reasons (e.g. difficult to empty directly into the toilet, did not feel the catheter completely emptied the bladder). At least 60% of subjects preferred the compact catheter. The outcomes seemed to indicate that this compact catheter improved QoL in a select neurogenic bladder population who were primarily mobile, with good hand dexterity. There needs to be further research on mixed populations. A concern in male patients would be bladder emptying because, if the catheter was not extended to its full length, the bladder may not be drained completely. The authors do not address some of the obvious limitations of this new catheter design.

  1. Pinder B, Lloyd AJ, Elwick H, Denys P, Marley J, Bonniaud V. Development and psychometric validation of the intermittent self-catheterization questionnaire. Clin Ther. 2012. Dec;34(12):2302-13. doi: 10.1016/j.clinthera.2012.10.006. Epub 2012 Nov 22.

 

Chartier-Kastler E, Amarenco G, Lindbo L, Soljanik I, Andersen HL, Bagi P, Gjødsbøl K, Domurath B

Reference: J Urol. 2013 Apr 12 (Epub ahead of print)
doi: 10.1016/j.juro.2013.04.026

PubMed Abstract
PMID: 23587630

Written by Diane K. Newman, DNP, FAAN, BCB-PMD