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

Primary Purpose

Urinary Catheters, Retention, Urinary, Incontinence, Urinary

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Novel gel installation device procedure

Standard procedure

About this trial

This is an interventional supportive care trial for Urinary Catheters focused on measuring Urinary catheterization, Gel installation, Novel medical device, Indwelling urinary catheter, Long-term urinary catheter, Male patients

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Skåne University Hospital - Urology clinic - Homecare unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novel gel installation device procedure

Standard procedure

Arm Description

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

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

Outcomes

Primary Outcome Measures

Treatment duration (min)

Treatment duration for procedure

Secondary Outcome Measures

Patient's perceived pain (NRS scale)

Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale)

Number of gel syringes used

Number of pre-filled gel syringes used during the procedure

Full Information

NCT ID

NCT03289117

First Posted

September 18, 2017

Last Updated

October 19, 2017

Sponsor

Region Skane

Collaborators

Lund University, Vinnova, Innovation Skåne AB/ Sweden

1. Study Identification

Unique Protocol Identification Number

NCT03289117

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

April 17, 2016 (Actual)

Primary Completion Date

May 26, 2017 (Actual)

Study Completion Date

May 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Skane

Collaborators

Lund University, Vinnova, Innovation Skåne AB/ Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Urinary catheterization, Gel installation, Novel medical device, Indwelling urinary catheter, Long-term urinary catheter, Male patients

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

Outcomes Assessor

Masking Description

Open label

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Novel gel installation device procedure

Arm Type

Experimental

Arm Description

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

Arm Title

Standard procedure

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Novel gel installation device procedure

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Standard procedure

Intervention Description

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

Primary Outcome Measure Information:

Title

Treatment duration (min)

Description

Treatment duration for procedure

Time Frame

During procedure

Secondary Outcome Measure Information:

Title

Patient's perceived pain (NRS scale)

Description

Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale)

Time Frame

During intervention

Title

Number of gel syringes used

Description

Number of pre-filled gel syringes used during the procedure

Time Frame

During intervention

Other Pre-specified Outcome Measures:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

Incidence of Treatment-Emergent Adverse Events found during procedure

Time Frame

During intervention

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulf Malmqvist, PhD

Organizational Affiliation

Clinical Studies Sweden - Forum South

Official's Role

Principal Investigator

Facility Information:

Facility Name

Skåne University Hospital - Urology clinic - Homecare unit

City

Lund

ZIP/Postal Code

22185

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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