Anesthesia, Local Clinical Trial
Official title:
Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Indwelling Urinary Catheters - a Randomized Controlled Study
A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate gel installation) for changing long-term indwelling urinary catheters.
This is a randomized, open label, controlled, parallel group study, which comprises one visit
that includes: assessment for eligibility, randomization to one of two treatment
alternatives, followed by the actual intervention and evaluation of outcomes.
The interventions are either change of catheter according to the regional standard procedure
(the comparator group) or change of catheter with the additional use of the novel device to
facilitate gel instillation and a slightly modified procedure (the experimental group).
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