Urinary Incontinence
Conditions
Brief summary
Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.
Detailed description
See brief summary
Interventions
DEVICETest Catheter - SpeediCath Compact Male
Compact catheter for intermittent catheterisation
DEVICESpeediCath
Catheter for intermittent catheterisation
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is a male IC user able to self-catheterise 2. Subject has used hydrophilic-coated ICs for at least 1 month 3. Subject is at least 18 years old. 4. Subject has provided informed consent.
Exclusion criteria
1. Subject has symptoms of UTI (ie, fever, autonomic dysreflexia, spasticity, discomfort or pain over the kidney or bladder, onset/increase in incontinence episodes, cloudy urine with increased odour, malaise, lethargy, or sense of unease). 2. Subject has known abnormalities in the lower urinary tract.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Residual Urine Volume | 3 catheterisations on 1 day | Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation |
Secondary
| Measure | Time frame |
|---|---|
| The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs) | Study period |
| Median Absolute RU Volume | 3 catheterisations on 1 day |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Includes groups randomized to standard catheter first and test catheter first | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Entire Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age Continuous | 39.5 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment Germany | 37 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Mean Residual Urine Volume
Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation
Time frame: 3 catheterisations on 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Catheter | Mean Residual Urine Volume | 12.4 mL | Standard Deviation 15.7 |
| Standard Catheter | Mean Residual Urine Volume | 9.4 mL | Standard Deviation 11.4 |
Secondary
Median Absolute RU Volume
Time frame: 3 catheterisations on 1 day
Secondary
The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)
Time frame: Study period