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

Coloplast A/S43 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Urinary Incontinence

Interventions

Investigational prototype deviceDEVICE

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

Comparator deviceDEVICE

The comparator is a urinary catheter for bladder drainage through the urethra.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 110 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

American Health Research

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.

Change in appearance of the bladder mucosa (∆=pre-catheterisation at baseline and post-catheterization and visit 2) rated on a 4-point scale. The 4-point scale defined as such: 1. no lesions evident; 2. minor mucosal and blood vessel lesions; 3. major blood vessel lesions, and 4. major mucosal and blood vessel lesions,

Time frame: 2 days

Data from ClinicalTrials.gov

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