Urinary Catheterization
Conditions
Brief summary
The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator. In the randomized part of the study the subjects will be given either LoFric Primo (POBE) or the comparator LoFric Primo (PVC) for use over 4 weeks. The hypothesis is that subject perception and satisfaction of POBE is equal to or better than for PVC.
Interventions
DEVICELoFric Primo (POBE) single-use urinary catheter
LoFric Primo (POBE) single-use urinary catheter
DEVICELoFric Primo (PVC) single-use urinary catheter
LoFric Primo (PVC) single-use urinary catheter
Sponsors
Wellspect HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent * Males and females aged 18 years and over * Experienced users of LoFric Primo with a minimum of one month of use * Practice CIC with LoFric Primo at least 3 times per day * Adults able to read, write and understand information given to them regarding the study
Exclusion criteria
* Ongoing symptomatic UTI * Suspicions of possible poor compliance with CIC during the study period * Previous enrolment or randomisation of treatment in the present study * Pregnancy * Subjects not able to perform self-catheterisation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Perception Regarding Handling of Test Catheter Before Insertion | At 4 weeks | Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) |
| Subject's Perception Regarding Handling of Test Catheter at Insertion | At 4 weeks | Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) |
| Subject's Perception Regarding Handling of Test Catheter at Withdrawal | At 4 weeks | Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) |
| Subject's Perception Regarding Handling of Test Catheter After Withdrawal | At 4 weeks | Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome) |
| Subject's General Satisfaction With Test Catheter | At 4 weeks | Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified) |
| Subject's Sensation When Using Test Catheter | At 4 weeks | Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain) |
Countries
Austria, Germany, Italy, Netherlands, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LoFric Primo (POBE) LoFric Primo (POBE) single-use urinary catheter (Arm A) | 97 |
| LoFric Primo (PVC) LoFric Primo (PVC) single-use urinary catheter (Arm B) | 98 |
| Total | 195 |
Baseline characteristics
| Characteristic | Total | LoFric Primo (POBE) | LoFric Primo (PVC) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 47 Participants | 23 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 148 Participants | 74 Participants | 74 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 16.66 | 52.5 years STANDARD_DEVIATION 16.16 | 51.1 years STANDARD_DEVIATION 17.2 |
| Region of Enrollment Austria | 34 participants | 16 participants | 18 participants |
| Region of Enrollment Germany | 42 participants | 22 participants | 20 participants |
| Region of Enrollment Italy | 44 participants | 21 participants | 23 participants |
| Region of Enrollment Netherlands | 44 participants | 22 participants | 22 participants |
| Region of Enrollment Sweden | 28 participants | 14 participants | 14 participants |
| Region of Enrollment United Kingdom | 3 participants | 2 participants | 1 participants |
| Sex: Female, Male Female | 44 Participants | 25 Participants | 19 Participants |
| Sex: Female, Male Male | 151 Participants | 72 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 97 | 7 / 98 |
| serious Total, serious adverse events | 2 / 97 | 1 / 98 |
Outcome results
Primary
Subject's General Satisfaction With Test Catheter
Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)
Time frame: At 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric Primo (POBE) | Subject's General Satisfaction With Test Catheter | 2.01 Score on scale | Standard Deviation 0.99 |
| LoFric Primo (PVC) | Subject's General Satisfaction With Test Catheter | 1.75 Score on scale | Standard Deviation 0.68 |
Primary
Subject's Perception Regarding Handling of Test Catheter After Withdrawal
Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Time frame: At 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric Primo (POBE) | Subject's Perception Regarding Handling of Test Catheter After Withdrawal | 1.63 Score on scale | Standard Deviation 1.05 |
| LoFric Primo (PVC) | Subject's Perception Regarding Handling of Test Catheter After Withdrawal | 1.69 Score on scale | Standard Deviation 0.98 |
Primary
Subject's Perception Regarding Handling of Test Catheter at Insertion
Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Time frame: At 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric Primo (POBE) | Subject's Perception Regarding Handling of Test Catheter at Insertion | 1.81 Score on scale | Standard Deviation 1.23 |
| LoFric Primo (PVC) | Subject's Perception Regarding Handling of Test Catheter at Insertion | 1.55 Score on scale | Standard Deviation 0.84 |
Primary
Subject's Perception Regarding Handling of Test Catheter at Withdrawal
Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Time frame: At 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric Primo (POBE) | Subject's Perception Regarding Handling of Test Catheter at Withdrawal | 1.55 Score on scale | Standard Deviation 0.93 |
| LoFric Primo (PVC) | Subject's Perception Regarding Handling of Test Catheter at Withdrawal | 1.44 Score on scale | Standard Deviation 0.77 |
Primary
Subject's Perception Regarding Handling of Test Catheter Before Insertion
Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)
Time frame: At 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric Primo (POBE) | Subject's Perception Regarding Handling of Test Catheter Before Insertion | 1.71 Score on scale | Standard Deviation 1.13 |
| LoFric Primo (PVC) | Subject's Perception Regarding Handling of Test Catheter Before Insertion | 1.76 Score on scale | Standard Deviation 1.05 |
Primary
Subject's Sensation When Using Test Catheter
Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)
Time frame: At 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LoFric Primo (POBE) | Subject's Sensation When Using Test Catheter | 1.86 Score on scale | Standard Deviation 0.9 |
| LoFric Primo (PVC) | Subject's Sensation When Using Test Catheter | 1.91 Score on scale | Standard Deviation 0.92 |