Intermittent Urethral Catheterization
Conditions
Brief summary
The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
Interventions
DEVICEZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
DEVICEZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
DEVICESpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.
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
1. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
Exclusion criteria
1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract 2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination) 3. Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period) 4. Known hypersensitivity toward any of the test products -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Discomfort During Catheterization | 1 day | Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort. |
Countries
Denmark
Participant flow
Pre-assignment details
40 subjects were included in the safety population. 4 subjects discontinued because they were unable to catheterize with given catheter. these drop-outs were distributed evenly among the catheter types: 1. subject: ZN-C 2. subjects: ZN-D 1 subjects: SC These subjects were excluded from the ITT population as no endpoints were registered for them
Participants by arm
| Arm | Count |
|---|---|
| All Participants The intention to treat population consists of 36 healthy male subjects | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Second Test Period | unable to catheterise | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 26.5 years STANDARD_DEVIATION 8.7 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Overall Discomfort During Catheterization
Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ZN-D Catheter | Overall Discomfort During Catheterization | 2.6 cm | Standard Deviation 2.2 |
| ZN-C Catheter | Overall Discomfort During Catheterization | 2.4 cm | Standard Deviation 1.7 |
| SpeediCath | Overall Discomfort During Catheterization | 1.8 cm | Standard Deviation 1.5 |