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The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product A in different positions. Measurement of residual urine at different positions. |
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| Sequence B | Experimental | Based on results from sequence A, sequence B may or may not be initiated. Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product B in different positions. Measurement of residual urine at different positions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SelfCath (comparator) | Device | Commercially available CE-marked catheter for urinary drainage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Bagi, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Per Bagi | Copenhagen | 2100 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A | Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product A in different positions. Measurement of residual urine at different positions. SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage. Product A SelfCath and urine bag, Conveen Security+: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices). |
| FG001 | Sequence B | Based on results from sequence A, sequence B may or may not be initiated. Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product B in different positions. Measurement of residual urine at different positions. SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage. Product B SelfCath and urine bag, Conveen Contour: SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Subjects with successful catheterization | 2-4 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Per Bagi, MD | Rigshospitalet, Department of Urology | +45 3545 8310 | Per.bagi@regionh.dk |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Product A SelfCath and urine bag, Conveen Security+ | Device | SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices). |
|
| Product B SelfCath and urine bag, Conveen Contour | Device | SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices). |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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). |
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| 0 |
| 8 |
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| 8 |
Investigators who want to publish/present results based on own data from a Coloplast-sponsored investigation, must send the publication/presentation to sponsor for review 60 days prior to submission. Sponsor reserves the right to delay publications to avoid compromising intellectual property. Publications of sub-analyses may be delayed by sponsor until main results of investigation have been published.
| D014947 | Wounds and Injuries |