The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Commercially available CE-marked catheter for urinary drainage.
SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).
Per Bagi
Copenhagen, Denmark
Residual Volume Less Than 100ml
The primary endpoint was "Residual volume less than 100 ml (Yes/No)" assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat. Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly. Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from "300ml - collected volume \<100ml" to "collected volume \> 200ml", were used to interpret the primary endpoint.
Time frame: 2-4 hours
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