An interventional study of Intermittent catheter and Compact intermittent catheter in Healthy, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-01.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Supportive care
Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.
61 studies on the registry are indexed under Hematuria; 18 are open to participants now.
This study's enrollment of 36 is below the median of 86 across 34 interventional studies indexed under Hematuria.
Browse Hematuria studies →Coloplast A/S is the lead sponsor of 150 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Speedicath (SC) catheter is a catheter for intermittent catherisation
Device: Intermittent catheter
SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males
Device: Compact intermittent catheter
SpeediCath catherter (SC) for intermittent catherisation
SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males
Residual Urine Measured by Ultra Sound
Time frame: 2
Subjectively Measured Handling
Subjectively Measured Insertion of the Catheter
| Milestone | SC Then SCCM | SCCM Then SC |
|---|---|---|
| Started | 18 | 18 |
| Completed | 17 | 18 |
| Not completed | 1 | 0 |
| Withdrew: Unable to insert catheter | 1 | 0 |
| Milestone | SC Then SCCM | SCCM Then SC |
|---|---|---|
| Started | 17 | 18 |
| Completed | 12 | 11 |
| Not completed | 5 | 7 |
| Withdrew: Unable to insert catheter | 1 | 1 |
| Withdrew: Protocol violation | 4 | 6 |
| ml | SpeediCath | SpediCath Compact Male |
|---|---|---|
| Residual Urine Measured by Ultra Sound | 11 ± 30 | 6 ± 23 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SC Then SCCM | — | 0/18 (0%) | 0/18 (0%) |
| SCCM Then SC | — | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | SC Then SCCM | SCCM Then SC | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 18 | 36 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | SC Then SCCM | SCCM Then SC | Total |
|---|---|---|---|
| Mean | 23.6 ± 3.0 | 23.9 ± 2.9 | 23.7 ± 2.9 |
| Sex: Female, Male(Participants) | SC Then SCCM | SCCM Then SC | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 18 | 18 | 36 |
| Region of Enrollment(participants) | SC Then SCCM | SCCM Then SC | Total |
|---|---|---|---|
| Denmark | 18 | 18 | 36 |
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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