New coating for urinary catheters
Clinical Investigation of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers
NA · Coloplast A/S · NCT06985888
This study is testing a new coating for urinary catheters to see if it makes the process more comfortable for healthy men compared to a standard coating.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Coloplast A/S (industry) |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06985888 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a newly developed hydrophilic coating for male intermittent catheters, comparing its discomfort level during catheterization to a standard coating. Participants will undergo catheterization by a healthcare professional at two visits, using both the investigational and comparator catheters in a randomized order. Discomfort will be assessed using a visual analog scale (VAS), and urine samples will be collected for analysis. The study involves 32 healthy male volunteers and spans a total duration of 4-21 days.
Who should consider this trial
Good fit: Ideal candidates are healthy males aged 18 and older with intact male anatomy and no urinary tract abnormalities.
Not a fit: Patients with urinary tract infections or known hypersensitivity to the devices used in the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to a more comfortable catheterization experience for patients using intermittent catheters.
How similar studies have performed: While similar studies have explored catheter coatings, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Has given written informed consent 2. Is at least 18 years old 3. Has full legal capacity 4. 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 5. Is able (assessed by investigator) and willing to adhere to study procedures during study duration. 6. Is able to refrain from using analgesics up to 24 hours prior to catheterisation visits 7. Is negative for haematuria, measured by urine dipstick test of erythrocytes Exclusion Criteria: 1. Is participating in any other clinical investigation during this investigation, which could affect the results of this investigation, as assessed by investigator. 2. Has previously been randomized in this investigation. 3. Has known hypersensitivity towards any of the devices used in the investigation 4. Is currently experiencing symptoms associated with UTI, as assessed by investigator. 5. Has known impaired sensation of the urethra
Where this trial is running
Copenhagen
- Department of Urology, Rigshospitalet — Copenhagen, Denmark (RECRUITING)
Study contacts
- Study coordinator: Mette Krogh
- Email: dkmekr@coloplast.com
- Phone: 49113245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Retention, Urinary