Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters
Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters
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).
Inclusion Criteria:

 -  The patient has an indwelling catheter and a primary diagnosis that justify continued
 catheter use

 -  The patient provides informed consent prior to any study specific procedures

 -  The patient is considered to benefit from participation in the clinical study

 Exclusion Criteria:

 -  The patient do not consent to participate in the study

 -  Trauma to urethra or bladder

 -  Infection to urethra or bladder

 -  Other diagnosis that contraindicates participation in the clinical study as judged by
 the responsible physician