Spinal Cord Injuries
Conditions
Brief summary
The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.
Interventions
DEVICESelfCath (comparator)
Commercially available CE-marked catheter for urinary drainage.
DEVICEProduct A SelfCath and urine bag, Conveen Security+
SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
DEVICEProduct B SelfCath and urine bag, Conveen Contour
SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).
Sponsors
Coloplast A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has given written informed consent * Is at least 18 years of age and has full legal capacity * Is a male * Has an Spinal Cord Injury diagnosis
Exclusion criteria
* Participating in other interventional clinical investigations or have previously participated in this investigation * Known hypersensitivity toward any of the test products * Serious abdominal scars * Symptoms of urinary tract infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Volume Less Than 100ml | 2-4 hours | The primary endpoint was Residual volume less than 100 ml (Yes/No) assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat. Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly. Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from 300ml - collected volume \<100ml to collected volume \> 200ml, were used to interpret the primary endpoint. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sequence A Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product A in different positions and measurement of residual urine.
SelfCath (comparator): Catheter for urinary drainage.
Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices). | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Sequence A |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 49.5 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment Denmark | 8 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Residual Volume Less Than 100ml
The primary endpoint was Residual volume less than 100 ml (Yes/No) assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat. Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly. Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from 300ml - collected volume \<100ml to collected volume \> 200ml, were used to interpret the primary endpoint.
Time frame: 2-4 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequence A | Residual Volume Less Than 100ml | Height 25cm | 6 Subjects with successful catheterization |
| Sequence A | Residual Volume Less Than 100ml | Height 20cm | 6 Subjects with successful catheterization |
| Sequence A | Residual Volume Less Than 100ml | Height 15cm | 6 Subjects with successful catheterization |
| Sequence A | Residual Volume Less Than 100ml | Height 10cm | 6 Subjects with successful catheterization |
| Sequence A | Residual Volume Less Than 100ml | Height 0cm | 7 Subjects with successful catheterization |