An interventional study of Coloplast test catheter in Incontinence, Urinary, sponsored by Coloplast A/S. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Supportive care
The aim of the study is to investigate the navigation of a newly developed catheter.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 153 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The subjects used the new Coloplast Test catheter for 1 week
Device: Coloplast test catheter
This is a newly developed catheter
Number of Participants Successfully Able to Insert Catheter
The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.
Time frame: 1 week
| Milestone | Tiemann/Coudé Users | Traditional Sleeve Catheter Users |
|---|---|---|
| Started | 95 | 58 |
| Completed | 87 | 55 |
| Not completed | 8 | 3 |
| Withdrew: Did not answer questionnaire | 8 | 3 |
| Milestone | Tiemann/Coudé Users | Traditional Sleeve Catheter Users |
|---|---|---|
| Started | 87 | 55 |
| Completed | 87 | 55 |
| Not completed | 0 | 0 |
The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: "How did you find the catheter navigates through the urethra during insertion" ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'.
| Participants | Tiemann/Coudé Users | Traditional Sleeve Catheter Users |
|---|---|---|
| Number of Participants Successfully Able to Insert Catheter | 82 | 58 |
Collected over Adverse events were collected during the trial period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tiemann/Coudé Users | 0/95 (0%) | 0/95 (0%) | 0/95 (0%) |
| Traditional Sleeve Catheter Users | 0/58 (0%) | 0/58 (0%) | 0/58 (0%) |
All the subjects enrolled in the study
| Age, Customized(participants) | Tiemann/Coudé Users | Traditional Sleeve Catheter Users | Total |
|---|---|---|---|
| Participants older than 18 years | 95 | 58 | 153 |
| Sex: Female, Male(Participants) | Tiemann/Coudé Users | Traditional Sleeve Catheter Users | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 95 | 58 | 153 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Coloplast A/S