Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter (CP341)

Coloplast

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: Investigational prototype device; Device: Comparator device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05224544

CP341

Details and patient eligibility

About

This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Each subject were enrolled in the investigation, which lasted up to 3 days (if Day 0 and Day 1 were not on same day). The subjects were randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product.

Full description

This investigation was a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.

Enrollment: 43 patients

Sex: Female

Ages: 18 to 110 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Has given written informed consent
2. Is at least 18 years and have full legal capacity
3. Is female
4. Has a negative urine Multistix dipstick test for erythrocytes (haematuria)

Exclusion criteria

1. Has used an internal urinary catheter or cystoscopy within the past month
2. Has prior history of bladder surgery
3. Is symptomatic and/or on medication for overactive bladder
4. Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate)
5. Is pregnant and/or breast-feeding
6. Is participating in other clinical investigations during this investigation
7. Is menstruating during study period

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Prototype Catheter

Experimental group

Description:

Healthy volunteers to test the prototype intermittent catheter with a microhole zone.

Treatment:

Device: Investigational prototype device

Comparator Catheter

Active Comparator group

Description:

Healthy volunteers to test the comparator intermittent catheter with two conventional eyelets.

Treatment:

Device: Comparator device