Compliance, Patient
Conditions
Brief summary
Performance and acceptance of new intermittent catheters tested in healthy volunteers
Detailed description
This study is a single blinded, randomised, crossover study. The study period consists of an information visit, an inclusion visit, three test visits and a termination visit. Two prototypes of intermittent catheters (Test product 2 and 3) compared to the standard catheter SpeediCath® Flex (Comparator). In the investigation ten subjects will be included. The subjects will be catheterised once per visit. The subjects will be catheterised with the two test catheters and comparator in a randomised order. The order of the catheterisations will be randomised to prevent bias. During the test visits the primary, secondary and explorative endpoints will be registered. Subjects will be asked to participate in an interview in continuation of their last visit (Test Visit 3). The interviews will be performed by a Coloplast representative asking questions related to their experience with the catheter. The subjects must sign a separate consent form for this purpose and can participate in the investigation without participating in the interview. In addition, subjects will be asked for consent to tape recording and filming during the interviews, but can participate in interviews without this. In addition, a Coloplast representative will interview the Investigator and her representatives after LPO with questions related to their experience with the catheters. The investigation is planned to be conducted in August 2018-Januar 2019. The visit window will be minimum five days between the visits (catheterisations), to ensure time for healing of any potential urethral trauma. However, the maximum time between visits should be adjusted to ensure the subject is terminated before LPO. No biobank will be established for this investigation. All urine samples in the clinical investigation (for evaluating in- and exclusion criteria and for evaluating end points) will be destructed immediately after analysis.
Interventions
DEVICETest product 2
Test catheter 2
DEVICETest product 3
Test catheter 3
DEVICEComparator
SpeediCath Flex
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Has given written informed consent and signed letter of authority Is at least 18 years of age and has full legal capacity Is a male Willing to comply without using analgetica up to 24 hours prior to catheterisation visits
Exclusion criteria
Has a previous history of genitourinary disease including congenital abnormalities and surgical procedures performed in the urinary tract Has symptoms of urinary tract infections (frequent urination, stinging and pain at urination) Are participating in any other clinical investigation related to urinary tract system during this investigation (inclusion to termination) Known hypersensitivity toward any of the test products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Flow Rate | 2 hour | On day of study visits 1-5 rate of urine flow through catheter measured in mL/s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-void Residual Urine | 2 hour | On day of study visits 1-5 rate volume of urine left in the bladder post catheterisation (in mL) |
| Number of Participants With Hematuria | 2 hour | On day of study visits 1-5 blood in urine post catheterisation (measured as yes/no to blood in urine) |
Countries
Denmark
Participant flow
Recruitment details
10 subjects were screened for eligibility
Pre-assignment details
9 out of 10 were randomized. The one not randomized did not meet the inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants The baseline measures include all study participants | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Washout (Minimum 5 Days) | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Age, Continuous | 35.9 years | — |
| Number of Participants with Hematuria at baseline | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 9 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 9 | 0 / 9 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 8 |
Outcome results
Primary
Urine Flow Rate
On day of study visits 1-5 rate of urine flow through catheter measured in mL/s
Time frame: 2 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test Product 2 | Urine Flow Rate | 5.43 mL per second |
| Test Product 3 | Urine Flow Rate | 5.47 mL per second |
| Comparator | Urine Flow Rate | 2.88 mL per second |
Secondary
Number of Participants With Hematuria
On day of study visits 1-5 blood in urine post catheterisation (measured as yes/no to blood in urine)
Time frame: 2 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Product 2 | Number of Participants With Hematuria | 0 Participants |
| Test Product 3 | Number of Participants With Hematuria | 0 Participants |
| Comparator | Number of Participants With Hematuria | 0 Participants |
Secondary
Post-void Residual Urine
On day of study visits 1-5 rate volume of urine left in the bladder post catheterisation (in mL)
Time frame: 2 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test Product 2 | Post-void Residual Urine | 38.33 mL |
| Test Product 3 | Post-void Residual Urine | 34.63 mL |
| Comparator | Post-void Residual Urine | 27.75 mL |