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

Coloplast

Status: Completed

Conditions: Retention, Urinary; Urinary Incontinence

Treatments: Device: Comparator device -VaPro intermittent catheter; Device: Investigational device - intermittent catheter with a micro-hole zone

Study type: Interventional

Funder types: Industry

Identifiers

NCT05485922

CP353

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Investigational device - intermittent catheter with a micro-hole zone

Experimental group

Description:

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.

Treatment:

Device: Investigational device - intermittent catheter with a micro-hole zone

Comparator device - VaPro intermittent catheter

Active Comparator group

Description:

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

Treatment:

Device: Comparator device -VaPro intermittent catheter