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

Not Applicable

Completed

• Conditions: Anesthesia, Local; Urinary Catheters; Retention, Urinary; Incontinence, Urinary
• Interventions: Device: Novel gel installation device procedure; Device: Standard procedure

• Registration Number: NCT03289117
• Lead Sponsor: Region Skane

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).

Study Timeline

• Study Start: 2016-04-17
• Primary Completion: 2017-05-26
• Study Completion: 2017-05-26
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel gel installation device procedure	Novel gel installation device procedure	Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device procedure
Standard procedure	Standard procedure	Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure

Primary Outcome Measures

Name	Time	Method
Treatment duration (min)	During procedure	Treatment duration for procedure

Secondary Outcome Measures

Name	Time	Method
Number of gel syringes used	During intervention	Number of pre-filled gel syringes used during the procedure
Patient's perceived pain (NRS scale)	During intervention	Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale)

Trial Locations

Locations (1)

Skåne University Hospital - Urology clinic - Homecare unit; 🇸🇪 Lund, Sweden