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

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  • Per Bagi
  • Jane Hannibalsen
  • Rikke Permild
  • Sine Stilling
  • Dagnia K Looms
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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.
Original languageEnglish
JournalUrologia Internationalis
Volume86
Issue number2
Pages (from-to)179-184
ISSN0042-1138
DOIs
Publication statusPublished - 27 Jan 2011

ID: 31005602