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

Study Overview
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Brief Summary
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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
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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).

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

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

Intervention / Treatment
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* Device: Novel gel installation device procedure
* Device: Standard procedure


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel gel installation device procedure<br>Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device procedure | Device: Novel gel installation device procedure<br>* Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device<br>|
| Active Comparator: Standard procedure<br>Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure | Device: Standard procedure<br>* Catheter change with standard procedure Each subject will undergo catheter change with standard procedure<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary catheterization, Gel installation, Novel medical device, Indwelling urinary catheter, Long-term urinary catheter, Male patients