NCT06985888

New Coating for Urinary Intermittent Catheters

Clinical Investigation of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Retention, Urinary

Interventions

Type	Name	Description
DEVICE	SpeediCath® Standard male new coating	Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male new coating CH12 by HCP
DEVICE	SpeediCath® Standard male	Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male CH 12 by HCP

Timeline

• Start date: 2025-05-06
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-05-22
• Last updated: 2025-08-14

Locations

1 site across 1 country: Denmark