Clinical Trial of New Single-use Compact Intermittent Catheter

Coloplast

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: Investigational device; Device: Comparator device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05841004

CP356

Details and patient eligibility

About

The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits. Visits 0 and 1 can be performed on the same day. Visit 2 can be performed the day after visit 1. For visit 1 and 2, catheterizations will be performed in a hospital setting by a health care professional for bladder emptying assessment and collection of urine samples for haematuria assessment. A sub-group of subjects (all enrolled subjects at DK sites) will be asked to conduct a self-catheterization at visit 2 after hcp catheterization and evaluate discomfort and PVR.

The total study duration for the individual subject will be up to 14 days.

Enrollment: 73 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is Female
• Is at least 18 years of age and has full legal capacity
• Has signed an informed consent form
• Has used clean intermittent self-catheterisation (CISC) (CH12 or CH14) for at least one month up to inclusion
• Is using intermittent self-catheterisation for a minimum of 3 times per day for bladder emptying
• Has used a compact catheter 50% of the time (or more) for the last two weeks prior to entering the study
• Has the ability (assessed by investigator) and willingness to follow study procedures or is able to use a compact catheter assessed by investigator

Exclusion criteria

• Is participating in any other clinical study during this investigation
• Has previously participated in this study
• Has symptoms of urinary tract infection at time of inclusion, as judged by the investigator (if the patient recovers within the recruitment period, a second inclusion is allowed, under a different subject id)
• Is an individual with a history of - suspected to be - or showing signs of producing an excessive amount of mucus or large/clustered sediments or debris
• Has any known allergies towards ingredients in the investigational device
• Is pregnant
• Is breastfeeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Investigational device - newly developed intermittent compact catheter

Experimental group

Description:

Ready-to-use, sterile, hydrophilic coated intermittent female compact catheter (CH12 and CH14) for urinary drainage. The investigational device is for single use.

Treatment:

Device: Comparator device

Device: Investigational device

Hollister Infyna Chic

Active Comparator group

Description:

The comparator is Hollister Infyna Chic, a CE-marked single-use compact catheter.

Treatment:

Device: Comparator device

Device: Investigational device