An interventional study of SpeediCath® Standard male new coating and SpeediCath® Standard male in Retention, Urinary, 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 2026-08-24.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Treatment
The goal is to confirm, that the newly developed coating is non-inferior to the comparator with respect to the overall discomfort of the catheterisation (assessed by participant).
Participants will attend 3 study site visits and will be catheterised by a HCP at visit 1 and 2 with one of the two catheters in randomisation order. Urine samples will be collected pre- and post catheterisation for assessments.
The primary objective of the study is to confirm that the newly developed investigational coating is non-inferior to the comparator coating with respect to the overall discomfort of catheterisation.
The investigational device is a ready-to-use, sterile, hydrophilic-coated Nelaton male catheter for intermittent catheterisation and based on the standard SpeediCath® male intermittent catheter with a difference in the composition on the coating.
The study is a double-blinded, randomized, crossover study including 32 randomized healthy male volunteers. The total study duration for the individual subject will be between 4-21 days and consists of 3 site visits V0, V1 and V2, and V0 andV1 can be combined
At V1 and V2 the subjects will be catheterized in a hospital setting by a health care professional, with one of the two catheters in a randomized order. Subject will be asked to assess the overall discomfort of the catheterisation on VAS.
235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.
This study's enrollment of 32 is below the median of 95 across 185 interventional studies indexed under Urinary Retention.
Browse Urinary Retention 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:
Device: SpeediCath® Standard male new coating · Device: SpeediCath® Standard male
Device: SpeediCath® Standard male new coating · Device: SpeediCath® Standard male
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male new coating CH12 by HCP
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male CH 12 by HCP
The Overall Discomfort During Catheterization Was Measured by VAS on a 10 cm Scale Ranging From "no Discomfort" (0 cm) to "Worst Possible Discomfort" (10 cm) Caused by the Catheter.
This endpoint was assessed by the subject immediately after completed catheterization, by setting a vertical line to indicate their experience of the overall catheterization.
Time frame: Immediately after the procedure
Between May 2025 and June 2025, 32 healthy male volunteers were recruited for the study from one investigational site.
| Milestone | Investigational Device Then Comparator Device | Comparator Then Investigational Device |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 16 |
| Not completed | 0 | 0 |
| Milestone | Investigational Device Then Comparator Device | Comparator Then Investigational Device |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 15 |
| Not completed | 0 | 1 |
| Withdrew: Catheterization could not be completed | 0 | 1 |
This endpoint was assessed by the subject immediately after completed catheterization, by setting a vertical line to indicate their experience of the overall catheterization.
| cm | Investigational Device | Comparator Device |
|---|---|---|
| The Overall Discomfort During Catheterization Was Measured by VAS on a 10 cm Scale Ranging From "no Discomfort" (0 cm) to "Worst Possible Discomfort" (10 cm) Caused by the Catheter. | 1.72 (1.23 to 2.21) | 1.46 (0.98 to 1.95) |
Collected over From enrollment to visit 2. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Investigational Device | 0/32 (0%) | 0/32 (0%) | 1/32 (3.1%) |
| Comparator Device | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Event | Investigational Device | Comparator Device |
|---|---|---|
| Blood in urineRenal and urinary disorders | 1/32 | 0/32 |
The population consisted of healthy male volunteers
| Age, Continuous(years) | The Full Analysis Set/Safety Population |
|---|---|
| Mean | 36.8 ± 11.8 |
| Sex: Female, Male(Participants) | The Full Analysis Set/Safety Population |
|---|---|
| Female | 0 |
| Male | 32 |
| Race and Ethnicity Not Collected(Participants) | The Full Analysis Set/Safety Population |
|---|
| Region of Enrollment(Participants) | The Full Analysis Set/Safety Population |
|---|---|
| Denmark | 32 |
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Coloplast A/S