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

NCT05224544 | Completed Results FDA Device

• 1 other identifier: CP341
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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,

  2 days

Study Arms (2)

Prototype Catheter

EXPERIMENTAL

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

Device: Investigational prototype device

Comparator Catheter

ACTIVE COMPARATOR

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

Device: Comparator device

Interventions

Investigational prototype device DEVICE

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

Also known as: prototype microhole zone catheter

Prototype Catheter

Comparator device DEVICE

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

Also known as: "Infyna chic"

Comparator Catheter

Eligibility Criteria

• Age: 18 Years - 110 Years
• Gender Eligibility Details: This device is a female catheter.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

American Health Research

Charlotte, North Carolina, 28277, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Malene Hornbak Landauro, Medical writer of Clinical strategies
• Organization: Coloplast, Clinical strategies

dkmhla@coloplast.com

+4549112057

Study Officials

• Selwyn Spangenthal, MD

  American Health Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: February 4, 2022
• Study Start: January 31, 2022
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: December 12, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)