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Product development project closed prematurely
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To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.
55 healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active comparator/Yellow catheter | Active Comparator | SpeediCath coated catheter |
|
| NonCE marked intermittent catheter/red | Experimental |
| |
| NonCE marked intermittent catheter/green | Experimental |
| |
| NonCE marked intermittent catheter/Blue | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent catheterisation | Device | Speedicath, Intermittent catheterisation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort during catheterisation measured by VAS-scale (0-10) | A subject is assesing a VAS scale after each catheterisation. | 10 measurements in an 11 week period. 10 min after each catheterisation |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety is evalueted continues while the subjects are testing the devices | During the investigation 11 Weeks per subject |
| Discomfort during urination post catheterisation | Subjects own assesment. Yes or no can be answered to discomfort during urination post catheterisation |
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Inclusion Criteria:
• ≥18 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Gürtler, CTM | Coloplast A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
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| NonCE marked intermittent catheter/red | Device | Paris, Intermittent catheterisation |
|
|
| NonCE marked intermittent catheter/green | Device | Paris, Intermittent catheter |
|
|
| NonCE marked intermittent catheter/blue | Device | Paris, Intermittent catheter |
|
|
| 10 measurements in an 11 week period. 10 min after each catheterisation |
| Haematuria | Urine test after each catheterisation, and measured on a urine stix | 10 measurements in an 11 week period. 10 min after each catheterisation |
| Handling during insertion, withdrawal | Ease of use assessed by nurses, measured on a 5 point scale | 10 measurements in an 11 week period. 10 min after each catheterisation |
| 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 |
| D014947 | Wounds and Injuries |
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