Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Indwelling Urinary Catheters - a Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Catheters
- Sponsor
- Region Skane
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Treatment duration (min)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Treatment duration (min)
Time Frame: During procedure
Treatment duration for procedure
Secondary Outcomes
- Patient's perceived pain (NRS scale)(During intervention)
- Number of gel syringes used(During intervention)