Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers

NCT04633291 | Completed Results

• 1 other identifier: CP279
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Site Pain; Catheter Site Discomfort

Outcome Measures

Primary Outcomes (1)

• Overall Discomfort During Nurse Catheterization

  Discomfort measured for the entire catheterization procedure (performed by nurse), using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.

  Immediately after the procedure/catheterization, up to 5 min.

Secondary Outcomes (8)

• Insertion Discomfort During Nurse Catheterization

  Immediately after the procedure/catheterization, up to 5 min.

• Withdrawal Discomfort During Nurse Catheterization

  Immediately after the procedure/catheterization, up to 5 min.

• Urination Discomfort After Catheterization

  Immediately after first normal void, up to 5 min.

• Catheter Handling During Insertion

  Immediately after the procedure/catheterization, up to 5 min.

• Catheter Handling During Withdrawal

  Immediately after the procedure/catheterization, up to 5 min.

Study Arms (2)

Novel swelling media

EXPERIMENTAL

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

Device: Novel swelling media

Comparator swelling media

ACTIVE COMPARATOR

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

Device: Comparator swelling media

Interventions

Novel swelling media DEVICE

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

Novel swelling media

Comparator swelling media DEVICE

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

Comparator swelling media

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)
• Known hypersensitivity toward any of the investigational device

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

Copenhagen, København Ø, 2100, Denmark

Location

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Coloplast A/S

clinical-studies@coloplast.com

+4549111111

Study Officials

• Per Bagi, MD

  Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 18, 2020
• Study Start: November 5, 2019
• Primary Completion: November 28, 2019
• Study Completion: November 28, 2019
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)