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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289117
• Other study ID #: 2016 02 01 ver 1_1
• Status: Completed
• Phase: N/A
• First received: September 18, 2017
• Last updated: October 19, 2017
• Start date: April 17, 2016
• Est. completion date: May 26, 2017

Study information

• Verified date: October 2017
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 26, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Novel gel installation device procedure
Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device
• Standard procedure
Catheter change with standard procedure Each subject will undergo catheter change with standard procedure

Locations

Country	Name	City	State
Sweden	Skåne University Hospital - Urology clinic - Homecare unit	Lund

Sponsors (4)

Lead Sponsor	Collaborator
Region Skane	Innovation Skåne AB/ Sweden, Lund University, Vinnova

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Treatment-Emergent Adverse Events found during procedure	During intervention
Primary	Treatment duration (min)	Treatment duration for procedure	During procedure
Secondary	Patient's perceived pain (NRS scale)	Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale)	During intervention
Secondary	Number of gel syringes used	Number of pre-filled gel syringes used during the procedure	During intervention