Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.
Interventions
DEVICESpeediCath Compact Male
CH 12 hydrophilic coated intermitten compact catheter
DEVICESpeedicath
CH 12 hydrophilic coated intermittent coated catheter
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * Male * Signed informed consent * Negative urine multistix
Exclusion criteria
* Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort | After each catheterisation | Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort) |
Secondary
| Measure | Time frame |
|---|---|
| Handling | After each catheterisation |
| Preference | At study termination |
| Haematuria | After each catheterisation |
Countries
Denmark
Participant flow
Pre-assignment details
28 participants enrolled in study. 2 were excluded before randomization as they did not comply with inclusion criteria. One was excluded from study (ITT) as participants dropped out before having any data recorded.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Test Day 1-2 Period | Lack of Efficacy | 0 | 2 |
| Test Day 2 - 2 Period | Lack of Efficacy | 1 | 0 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age Continuous | 27.3 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment Denmark | 25 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Discomfort
Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)
Time frame: After each catheterisation
Population: The number analized was the number of participants catherised with each catheter at least onze during the study(SC or SCCM)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Catheter SCCM | Discomfort | 2.25 units on a scale | Standard Deviation 1.5 |
| Standard Catheter SC | Discomfort | 2.52 units on a scale | Standard Deviation 1.8 |
Secondary
Haematuria
Time frame: After each catheterisation
Secondary
Handling
Time frame: After each catheterisation
Secondary
Preference
Time frame: At study termination