Spinal Cord Injuries
Conditions
Brief summary
The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.
Detailed description
See brief summary
Interventions
DEVICEtest intermittent catheter
CH 12 hydrophilic coated catheter
CH 12 hydrophilic catheter
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Has normal/impaired sensation in the urethra * Self-catheterises at least 4 times per day * Has used clean self-intermittent catheterisation for at least 14 days * Is able to open and prepare the catheters for catheterisation * Has signed the informed consent before any study related-activities.
Exclusion criteria
* Has a symptomatic urinary tract infection as assessed by the investigator * Is mentally unstable as assessed by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. | 14 days | Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days. At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort) |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Test Period 1 (1-14 Days) | Adverse Event | 1 | 0 |
| Test Period 1 (1-14 Days) | Lack of Efficacy | 0 | 2 |
| Test Period 1 (1-14 Days) | Other | 1 | 0 |
| Test Period 1 (1-14 Days) | Withdrawal by Subject | 2 | 0 |
| Test Period 2 (15-28 Days) | Adverse Event | 1 | 0 |
| Test Period 2 (15-28 Days) | Lack of Efficacy | 1 | 0 |
| Test Period 2 (15-28 Days) | Other | 0 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age Continuous | 43.2 years |
| Region of Enrollment Denmark | 24 participants |
| Region of Enrollment France | 12 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 32 | 1 / 34 |
| serious Total, serious adverse events | 0 / 32 | 0 / 34 |
Outcome results
Primary
Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.
Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days. At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)
Time frame: 14 days
Population: Six participants discontinued the study in the first test period, i.e. before visit 2 at which the first catheter evaluation was to be given. The primary outcome was the catheter evaluation on discomfort, and these six participants did not contribute to the ITT analysis of the primary outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Catheter | Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. | 1.59 units on a scale | Standard Deviation 2.28 |
| Standard Catheter | Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. | 1.94 units on a scale | Standard Deviation 2.24 |