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The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.
See brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test intermittent catheter | Experimental | CH 12 hydrophilic coated catheter |
|
| intermittent catheter | Experimental | CH 12 hydrophilic coated catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| test intermittent catheter | Device | CH 12 hydrophilic coated catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. | Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days. At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort) | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fin Biering-Sørensen, MD | Klinik for Rygmarvsskader, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik for Rygmarvsskader | Hornbæk | 3100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34699062 | Derived | Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5. | |
| 21339763 | Derived | Chartier-Kastler E, Lauge I, Ruffion A, Goossens D, Charvier K, Biering-Sorensen F. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study. Spinal Cord. 2011 Jul;49(7):844-50. doi: 10.1038/sc.2011.5. Epub 2011 Feb 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | A: First Test Catheter Then Standard Catheter | Test catheter is a CH 12 hydrophilic coated intermittent catheter |
| FG001 | B: First Standard Catheter Then Test Catheter | Test catheter is a CH 12 hydrophilic coated intermittent catheter |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Period 1 (1-14 Days) |
|
| |||||||||||||||||||||
| Test Period 2 (15-28 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| 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 | Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. | Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days. At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort) | Six participants discontinued the study in the first test period, i.e. before visit 2 at which the first catheter evaluation was to be given. The primary outcome was the catheter evaluation on discomfort, and these six participants did not contribute to the ITT analysis of the primary outcome. | Posted | Mean | Standard Deviation | units on a scale | 14 days |
|
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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 | Test Catheter | SpeediCath Compact Male |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epididymitis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristine Gjødsbøl, PhD | Coloplast | +4549113557 | dkkg@coloplast.com |
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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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| ID | Term |
|---|---|
| D057928 | Intermittent Urethral Catheterization |
| ID | Term |
|---|---|
| D014546 | Urinary Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Intermittent catheterization | Device | CH 12 hydrophilic catheter |
|
|
| Other |
|
| Lack of Efficacy |
|
| NOT COMPLETED |
|
|
| Participants |
|
| Age Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
SpeediCath Compact Male Catheter
| OG001 | Standard Catheter | SpeediCath Catheter |
|
|
| 0 |
| 32 |
| 1 |
| 32 |
| EG001 | Standard Catheter | SpeediCath, CH 12 hydrophilic coated intermittent catheter | 0 | 34 | 1 | 34 |
| discomfort during insertion | Renal and urinary disorders |
|
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| D014947 | Wounds and Injuries |