Retention, Urinary
Conditions
Brief summary
The goal is to confirm, that the newly developed coating is non-inferior to the comparator with respect to the overall discomfort of the catheterisation (assessed by participant). Participants will attend 3 study site visits and will be catheterised by a HCP at visit 1 and 2 with one of the two catheters in randomisation order. Urine samples will be collected pre- and post catheterisation for assessments.
Detailed description
The primary objective of the study is to confirm that the newly developed investigational coating is non-inferior to the comparator coating with respect to the overall discomfort of catheterisation. The investigational device is a ready-to-use, sterile, hydrophilic-coated Nelaton male catheter for intermittent catheterisation and based on the standard SpeediCath® male intermittent catheter with a difference in the composition on the coating. The study is a double-blinded, randomized, crossover study including 32 randomized healthy male volunteers. The total study duration for the individual subject will be between 4-21 days and consists of 3 site visits V0, V1 and V2, and V0 andV1 can be combined At V1 and V2 the subjects will be catheterized in a hospital setting by a health care professional, with one of the two catheters in a randomized order. Subject will be asked to assess the overall discomfort of the catheterisation on VAS.
Interventions
DEVICESpeediCath® Standard male new coating
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male new coating CH12 by HCP
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male CH 12 by HCP
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Has given written informed consent 2. Is at least 18 years old 3. Has full legal capacity 4. Has self-assessed intact male anatomy with no abnormalities or disease of the lower urinary tract or any surgical procedures performed in the lower urinary tract 5. Is able (assessed by investigator) and willing to adhere to study procedures during study duration. 6. Is able to refrain from using analgesics up to 24 hours prior to catheterisation visits 7. Is negative for haematuria, measured by urine dipstick test of erythrocytes
Exclusion criteria
1. Is participating in any other clinical investigation during this investigation, which could affect the results of this investigation, as assessed by investigator. 2. Has previously been randomized in this investigation. 3. Has known hypersensitivity towards any of the devices used in the investigation 4. Is currently experiencing symptoms associated with UTI, as assessed by investigator. 5. Has known impaired sensation of the urethra
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Overall Discomfort During Catheterization Was Measured by VAS on a 10 cm Scale Ranging From "no Discomfort" (0 cm) to "Worst Possible Discomfort" (10 cm) Caused by the Catheter. | Immediately after the procedure | This endpoint was assessed by the subject immediately after completed catheterization, by setting a vertical line to indicate their experience of the overall catheterization. |
Countries
Denmark
Participant flow
Recruitment details
Between May 2025 and June 2025, 32 healthy male volunteers were recruited for the study from one investigational site.
Pre-assignment details
The 32 recruited participants were randomized into the two intervention arms.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment Denmark | 32 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 1 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
None listed