Clinical trial NCT06985888: New Coating for Urinary Intermittent Catheters
Official title: Clinical Investigation of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retention, Urinary
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2025-05-22
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Overall discomfort of the catheterisation
timeFrame: immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Urology, Rigshospitalet
Study officials:
References: