Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters

Region Skane

Status: Completed

Conditions: Anesthesia, Local; Urinary Catheters; Incontinence, Urinary; Retention, Urinary

Treatments: Device: Novel gel installation device procedure; Device: Standard procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03289117

2016 02 01 ver 1_1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Novel gel installation device procedure

Experimental group

Description:

Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device procedure

Treatment:

Device: Novel gel installation device procedure

Standard procedure

Active Comparator group

Description:

Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure

Treatment:

Device: Standard procedure