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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Incontinence, Urinary; Urinary Catheters; Retention, Urinary
• Intervention / Treatment: Device: Novel gel installation device procedure; Device: Standard procedure

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Skåne University Hospital - Urology clinic - Homecare unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment duration (min)	Treatment duration for procedure	During procedure

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Treatment-Emergent Adverse Events found during procedure	During intervention

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University; Vinnova; Innovation Skåne AB/ Sweden
• Investigators: Principal Investigator: Ulf Malmqvist, PhD, Clinical Studies Sweden - Forum South

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2016
• Primary Completion (Actual): May 26, 2017
• Study Completion (Actual): May 26, 2017

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Urinary catheterization; Gel installation; Novel medical device; Indwelling urinary catheter; Long-term urinary catheter; Male patients
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Retention
• Other Study ID Numbers: 2016 02 01 ver 1_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No