NCT03289117

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 Indwelling Urinary Catheters - a Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Urinary Catheters
• Retention, Urinary
• Incontinence, Urinary
• Anesthesia, Local

Interventions

Type	Name	Description
DEVICE	Novel gel installation device procedure	Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device
DEVICE	Standard procedure	Catheter change with standard procedure Each subject will undergo catheter change with standard procedure

Timeline

• Start date: 2016-04-17
• Primary completion: 2017-05-26
• Completion: 2017-05-26
• First posted: 2017-09-20
• Last updated: 2017-10-20

Locations

1 site across 1 country: Sweden