Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

NCT ID: NCT04633291

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2019-11-28

Brief Summary

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.

Detailed 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.

Conditions

Catheter Site Pain; Catheter Site Discomfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Novel swelling media

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

Group Type: EXPERIMENTAL

Novel swelling media

Intervention Type: DEVICE

Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.

Comparator swelling media

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

Group Type: ACTIVE_COMPARATOR

Comparator swelling media

Intervention Type: DEVICE

Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.

Interventions

Novel swelling media

Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.

Intervention Type: DEVICE

Comparator swelling media

Intermittent catheterization through the urethra draining the bladder, performed by a trained nurse.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Bagi, MD

Role: PRINCIPAL_INVESTIGATOR

Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

Locations

Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

Copenhagen, København Ø, Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP279

Identifier Type: -

Identifier Source: org_study_id