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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheterisation with investigational device and Comparator | Other |
| |
| Catheterisation with Comparator and Investigational device | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpeediCath® Standard male new coating | Device | Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male new coating CH12 by HCP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall discomfort of the catheterisation | assessed by subject using VAS | immediately after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Rigshospitalet | Copenhagen | 2100 | Denmark |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 11, 2026 | |
| Reset | Jun 4, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2026 | Jun 4, 2026 | |||
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| SpeediCath® Standard male | Device | Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male CH 12 by HCP |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |