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

NCT ID: NCT05224544

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-03-31

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.

Detailed 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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Prototype Catheter

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

Group Type: EXPERIMENTAL

Investigational prototype device

Intervention Type: DEVICE

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

Comparator Catheter

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

Group Type: ACTIVE_COMPARATOR

Comparator device

Intervention Type: DEVICE

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

Interventions

Investigational prototype device

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

Intervention Type: DEVICE

Comparator device

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

Intervention Type: DEVICE

Other Intervention Names

prototype microhole zone catheter; "Infyna chic"

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Selwyn Spangenthal, MD

Role: PRINCIPAL_INVESTIGATOR

American Health Research

Locations

American Health Research

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP341

Identifier Type: -

Identifier Source: org_study_id