Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

Coloplast

Status: Completed

Conditions: Catheter Site Discomfort; Catheter Site Pain

Treatments: Device: Comparator swelling media; Device: Novel swelling media

Study type: Interventional

Funder types: Industry

Identifiers

NCT04633291

CP279

Details and patient eligibility

About

Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.

Full description

The CP279 study investigated a novel swelling media for male intermittent urinary catheters. The study was conducted in Denmark and was a single-site, randomized, single blinded, cross-over investigation, testing inferiority of a novel catheter swelling media against a comparator swelling media in 22 adult, healthy, male volunteers.

Each participant was randomized to one of two treatment arms, using a randomization sequence of two (i.e., with two different random options for the order in which the participants tested the two swelling media). The study thus contained two test visits, for which the 22 participants tested the two different swelling media, respectively. There was 4-14 days between the test visits and all catheterizations were performed by trained nurses. Due to a visual difference between the products, it was only possible to blind the subjects.

Enrollment: 22 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent given
• Minimum 18 years of age and with full legal capacity
• Male gender
• Willing to refrain from using analgesics up to 24 hours prior to catheterization visits
• Negative urine multistix analysis for erythrocytes (microscopic hematuria)
• Negative urine multistix analysis for leukocytes and nitrite, or if positive, subsequent negative for bacterial growth in urine culture

Exclusion criteria

• Abnormalities, diseases or surgical procedures performed in the lower urinary tract
• Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
• Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or previously participation in this investigation
• Known hypersensitivity toward any of the investigational device

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Novel swelling media

Experimental group

Description:

Participants underwent catheterization with the SpeediCath standard male catheter containing the novel swelling media. The catheterization was performed by a trained nurse.

Treatment:

Device: Novel swelling media

Comparator swelling media

Active Comparator group

Description:

Participants underwent catheterization with CE-marked SpeediCath® standard male containing the original swelling media. The catheterization was performed by a trained nurse.

Treatment:

Device: Comparator swelling media