PMID- 21358718
OWN - NLM
STAT- MEDLINE
DCOM- 20120514
LR  - 20110701
IS  - 1476-5624 (Electronic)
IS  - 1362-4393 (Linking)
VI  - 49
IP  - 7
DP  - 2011 Jul
TI  - Clinical evaluation of a newly developed catheter (SpeediCath Compact Male) in 
      men with spinal cord injury: residual urine and user evaluation.
PG  - 817-21
LID - 10.1038/sc.2011.14 [doi]
AB  - OBJECTIVE: To evaluate the performance of a new 30-cm-long, telescoping male 
      intermittent catheter (SpeediCath Compact Male; Coloplast A/S, Humlebaek, Denmark) 
      in urinary bladder emptying, safety and subject acceptance vs a standard-length 
      male intermittent catheter (SpeediCath). MATERIALS AND METHODS: In a prospective, 
      randomized, multicenter, crossover non-inferiority study, 37 male intermittent 
      catheter users self-catheterized three times with the test catheter on one test 
      day and three times with the standard-length male (reference) catheter on another 
      test day. Residual urine (RU) volume in the bladder after catheterization was 
      measured by ultrasound. Safety was assessed in the entire study period in terms 
      of adverse events (AEs) and adverse device events (ADEs). Subjects evaluated 
      their experience, sensation, disposal, bleeding and discomfort with the test and 
      reference catheters and final catheter preference. RESULTS: SpeediCath Compact 
      Male did not differ from the reference catheter in terms of performance (bladder 
      emptying). The upper confidence limit of the mean difference between absolute RU 
      volumes for the test and reference catheter groups did not exceed a 
      pre-established non-inferiority limit of 20  ml, thereby showing the test 
      catheter's non-inferiority to the reference catheter (that is, no worse at 
      bladder emptying). The only AE/ADE reported was one instance of mild urethral 
      burning for 30  min after catheterization, which was judged possibly related to 
      the test catheter but resolved quickly. CONCLUSIONS: The SpeediCath Compact Male 
      catheter is as efficient as a conventional intermittent catheter (SpeediCath) at 
      emptying the bladder with the additional benefit of being more discreet and 
      easier to use.
FAU - Domurath, B
AU  - Domurath B
AD  - Department for Neuro-Urology, Werner-Wicker-Clinic, Bad Wildungen, Germany. 
      bdo@werner-wicker-klinik.de
FAU - Kutzenberger, J
AU  - Kutzenberger J
FAU - Kurze, I
AU  - Kurze I
FAU - Knoth, H S
AU  - Knoth HS
LA  - eng
SI  - ClinicalTrials.gov/NCT01048541
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110301
PL  - England
TA  - Spinal Cord
JT  - Spinal cord
JID - 9609749
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cross-Over Studies
MH  - Humans
MH  - Intermittent Urethral Catheterization/adverse effects/*instrumentation/*methods
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Spinal Cord Injuries/complications/*physiopathology
MH  - Time Factors
MH  - Urinary Bladder, Neurogenic/etiology/physiopathology/*therapy
MH  - Young Adult
EDAT- 2011/03/02 06:00
MHDA- 2012/05/15 06:00
CRDT- 2011/03/02 06:00
PHST- 2011/03/02 06:00 [entrez]
PHST- 2011/03/02 06:00 [pubmed]
PHST- 2012/05/15 06:00 [medline]
AID - sc201114 [pii]
AID - 10.1038/sc.2011.14 [doi]
PST - ppublish
SO  - Spinal Cord. 2011 Jul;49(7):817-21. doi: 10.1038/sc.2011.14. Epub 2011 Mar 1.