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

Sponsor

Region Skane (Other)

Overall Status

Completed

CT.gov ID

NCT03289117

Collaborator

Lund University (Other), Vinnova (Other), Innovation Skåne AB/ Sweden (Other)

Enrollment

Location

Arms

13.3

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Catheters Retention, Urinary Incontinence, Urinary Anesthesia, Local	Device: Novel gel installation device procedure Device: Standard procedure	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Arm 1: Experimental: Novel device: Assigned Interventions: Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device. Arm 2: Comparator: Standard procedure: Assigned Interventions: Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure.Arm 1: Experimental: Novel device: Assigned Interventions: Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device. Arm 2: Comparator: Standard procedure: Assigned Interventions: Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure.

Masking:

Single (Outcomes Assessor)

Masking Description:

Open label

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 17, 2016

Actual Primary Completion Date :

May 26, 2017

Actual Study Completion Date :

May 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Novel gel installation device procedure Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device procedure	Device: Novel gel installation device procedure Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device
Active Comparator: Standard procedure Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure	Device: Standard procedure Catheter change with standard procedure Each subject will undergo catheter change with standard procedure

Arm

Intervention/Treatment

Experimental: Novel gel installation device procedure

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

Device: Novel gel installation device procedure

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

Active Comparator: Standard procedure

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

Device: Standard procedure

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

Outcome Measures

Primary Outcome Measures

Treatment duration (min) [During procedure]
Treatment duration for procedure

Secondary Outcome Measures

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

Other Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [During intervention]
Incidence of Treatment-Emergent Adverse Events found during procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts 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