Neurogenic Bladder Dysfunction Nos
Conditions
Brief summary
The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.
Interventions
DEVICESpeediCath Compact
The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.
DEVICEStandard care
The coated intermittent catheter normally used by subject
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 18 years of age * Has given written informed consent * Has neurogenic bladder dysfunction * Has used coated intermittent catheter as primarily bladder emptying method for at least 6 months * Is able to self-catheterise * Is able to use SpeediCath® compact catheters * If spinal cord injury subject, injury must have occurred more than 12 months ago * Covered by Social security system
Exclusion criteria
* Has used SpeediCath® compact catheters (not including screening for this investigation) * Is admitted to rehabilitation centre * Subjects using primarily catheter sets * Is pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (0-100 Point) | 6 weeks | Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life. |
Countries
Denmark, France, Germany, Norway, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants 125 subjects were randomized in this study, however 7 subjects discontinued only providing baseline data and were therefore excluded from the ITT population as they did not contribute with any endpoint data.
The baseline and analysis data are based on the ITT population. | 118 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 0 |
| Period 1 | Felt unable to empty bladder | 1 | 0 |
| Period 1 | Lack of Efficacy | 1 | 0 |
| Period 1 | Lost to Follow-up | 1 | 0 |
| Period 1 | Withdrawal by Subject | 6 | 2 |
| Period 2 | Adverse Event | 1 | 0 |
| Period 2 | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 15.5 |
| Region of Enrollment Denmark | 27 participants |
| Region of Enrollment France | 40 participants |
| Region of Enrollment Germany | 18 participants |
| Region of Enrollment Norway | 5 participants |
| Region of Enrollment Sweden | 28 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 123 | 14 / 115 |
| serious Total, serious adverse events | 3 / 123 | 2 / 115 |
Outcome results
Primary
Quality of Life (0-100 Point)
Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.
Time frame: 6 weeks
Population: The primary analysis was based on the ITT population which included 118 subjects. 7 subjects were excluded from the ITT population. They were excluded because they discontniued the investigation and only baseline data was collected from them. Furthermore, not all subjects in the ITT population answered the QoL questionaire for both products.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compact Catheter | Quality of Life (0-100 Point) | 76.8 units on a scale | Standard Deviation 14.5 |
| Standard Care | Quality of Life (0-100 Point) | 59.8 units on a scale | Standard Deviation 19.3 |