New Coating for Urinary Intermittent Catheters

NCT06985888 | Completed

• 1 other identifier: CP372
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retention, Urinary

Outcome Measures

Primary Outcomes (1)

• Overall discomfort of the catheterisation

  assessed by subject using VAS

  immediately after the procedure

Study Arms (2)

Catheterisation with investigational device and Comparator

OTHER

Device: SpeediCath® Standard male new coating; Device: SpeediCath® Standard male

Catheterisation with Comparator and Investigational device

OTHER

Device: SpeediCath® Standard male new coating; Device: SpeediCath® Standard male

Interventions

SpeediCath® Standard male new coating DEVICE

Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male new coating CH12 by HCP

Catheterisation with Comparator and Investigational device; Catheterisation with investigational device and Comparator

SpeediCath® Standard male DEVICE

Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male CH 12 by HCP

Catheterisation with Comparator and Investigational device; Catheterisation with investigational device and Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has given written informed consent
• Is at least 18 years old
• Has full legal capacity
• Has self-assessed intact male anatomy with no abnormalities or disease of the lower urinary tract or any surgical procedures performed in the lower urinary tract
• Is able (assessed by investigator) and willing to adhere to study procedures during study duration.
• Is able to refrain from using analgesics up to 24 hours prior to catheterisation visits
• Is negative for haematuria, measured by urine dipstick test of erythrocytes

You may not qualify if:

• Is participating in any other clinical investigation during this investigation, which could affect the results of this investigation, as assessed by investigator.
• Has previously been randomized in this investigation.
• Has known hypersensitivity towards any of the devices used in the investigation
• Is currently experiencing symptoms associated with UTI, as assessed by investigator.
• Has known impaired sensation of the urethra

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Department of Urology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 22, 2025
• Study Start: May 6, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-05

Locations

DK (1)