Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.
See brief summary
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
37
Compact catheter for intermittent catheterisation
Catheter for intermittent catheterisation
Werner-Wicker-Klinik, Abteilung für Neuro-Urologie
Bad Wildungen, Hesse, Germany
Mean Residual Urine Volume
Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation
Time frame: 3 catheterisations on 1 day
The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)
Time frame: Study period
Median Absolute RU Volume
Time frame: 3 catheterisations on 1 day
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