Incontinence, Urinary
Conditions
Brief summary
The aim of the study is to investigate the navigation of a newly developed catheter.
Interventions
DEVICEColoplast test catheter
This is a newly developed catheter
Sponsors
Coloplast A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and at least 18 years 2. Has used Intermittent self-catheterization at least 3 months 3. Has normal to slightly reduced hand mobility 4. Use catheter size CH12 or CH14 (must use same size during product evaluation)
Exclusion criteria
1. Currently receiving treatment for urinary tract infection 2. Currently receiving chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Successfully Able to Insert Catheter | 1 week | The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: How did you find the catheter navigates through the urethra during insertion ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tiemann/Coudé Users The Tiemann/Coudé users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial.
Coloplast test catheter: This is a newly developed catheter | 95 |
| Traditional Sleeve Catheter Users The traditional sleeve catheter users used the new Coloplast Test catheter for 1 week. At inclusion the subjects were introduced to the product. They were asked to perform catheterization with Coloplast Test catheter. Those who were able to catheterize and wished to participate were included in the 1 week trial. | 58 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Inclusion Visit | did not answer questionnaire | 8 | 3 |
Baseline characteristics
| Characteristic | Tiemann/Coudé Users | Traditional Sleeve Catheter Users | Total |
|---|---|---|---|
| Age, Customized Participants older than 18 years | 95 participants | 58 participants | 153 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 95 Participants | 58 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 58 |
| other Total, other adverse events | 0 / 95 | 0 / 58 |
| serious Total, serious adverse events | 0 / 95 | 0 / 58 |
Outcome results
Primary
Number of Participants Successfully Able to Insert Catheter
The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: How did you find the catheter navigates through the urethra during insertion ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tiemann/Coudé Users | Number of Participants Successfully Able to Insert Catheter | 82 Participants |
| Traditional Sleeve Catheter Users | Number of Participants Successfully Able to Insert Catheter | 58 Participants |