title: Safety of a new compact male intermittent catheter: randomized, cross-over, single-blind study in healthy male volunteers.
abstract: BACKGROUND
  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.
authors.affiliation: Department of Urology D, Rigshospitalet, Copenhagen, Denmark. per.bagi @ rh.regionh.dk
authors.forename: Per
authors.initials: P
authors.lastname: Bagi
authors.forename: Jane
authors.initials: J
authors.lastname: Hannibalsen
authors.forename: Rikke
authors.initials: R
authors.lastname: Permild
authors.forename: Sine
authors.initials: S
authors.lastname: Stilling
authors.forename: Dagnia K
authors.initials: DK
authors.lastname: Looms
mesh_terms: D000293:Adolescent; D000328:Adult; D002404:Catheterization / Q000295:instrumentation*; D057785:Catheters; D018592:Cross-Over Studies; D004867:Equipment Design; D006417:Hematuria / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012449:Safety; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014554:Urination