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Completed

NCT Number: NCT05224544

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

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.

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Key information

Conditions

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

Age range

18 year–110 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

American Health Research

Charlotte, North Carolina, 28277, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Investigational prototype device

Device

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

Other names: prototype microhole zone catheter

Comparator device

Device

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

Other names: "Infyna chic"

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.

    Time frame: 2 days

    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:

    • no lesions evident;
    • minor mucosal and blood vessel lesions;
    • major blood vessel lesions, and
    • major mucosal and blood vessel lesions,

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study title

Exploratory Study Investigating the Acute Effect of Intermittent Catheterization on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter Compared to a Conventional 2-eyelet Catheter

Acronym: CP341

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2022
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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