Performance of a Single-use Intermittent Micro-hole Zone Catheter

NCT ID: NCT05485922

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-23
• Study Completion Date: 2022-11-04

Brief Summary

The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.

The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.

Detailed Description

The investigation was a single-centre, randomized, controlled crossover study including 42 male participants comparing the performance of two intermittent catheters (IC).

The study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. There were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day.

Conditions

Urinary Incontinence; Retention, Urinary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Investigational device - intermittent catheter with a micro-hole zone

A ready-to-use, sterile, hydrophilic-coated male catheter for intermittent catheterisation with a flexible tip and a micro-hole zone for urinary drainage in sizes CH12 and CH14. The catheterization was performed by a trained nurse.

Group Type: EXPERIMENTAL

Investigational device - intermittent catheter with a micro-hole zone

Intervention Type: DEVICE

The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.

Comparator device - VaPro intermittent catheter

Hollister VaPro, a single-use hydrophilic sleeved soft/flexible catheters in the sizes CH12 or CH14. The catheterization was performed by a trained nurse.

Group Type: ACTIVE_COMPARATOR

Comparator device -VaPro intermittent catheter

Intervention Type: DEVICE

The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.

Interventions

Investigational device - intermittent catheter with a micro-hole zone

The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.

Intervention Type: DEVICE

Comparator device -VaPro intermittent catheter

The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Is Male

2. Is at least 18 years of age and has full legal capacity

3. Has given written informed consent

4. Has signed letter of authority (only DK)

5. Has used clean intermittent catheterisation CH12 or CH14 for at least one month

6. Use intermittent catheterisation as the primary bladder emptying method

7. Is able (assessed by investigator) and willing to follow study procedures

Exclusion Criteria

1. Is participating in any other clinical study during this investigation

2. Has previous participated in this study

3. Has symptoms of urinary tract infection as judged by the investigator 4 Is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris

5. Has any known allergies towards ingredients in the investigational device

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilie Rovsing, MD

Role: PRINCIPAL_INVESTIGATOR

Sanos

Locations

Sanos Clinic

Gandrup, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP353

Identifier Type: -

Identifier Source: org_study_id