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

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: Comparator; Device: Nautilus Catheter

• Registration Number: NCT05224544
• Lead Sponsor: Coloplast A/S

Brief Summary

This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, 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 test product or the comparator product, with at least 20 subjects assigned to each product.

Detailed Description

This investigation is 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 test product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.

Study Timeline

• Study First Submitted: 2021-12-03
• Study Start: 2022-01-31
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-04
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2023-12
• Results First Submitted: 2023-12-19
• Results First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Results First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator Catheter	Comparator	Healthy volunteers to test the comparator.
Test Catheter	Nautilus Catheter	Healthy volunteers to test the investigational intermittent catheter.

Primary Outcome Measures

Name	Time	Method
Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.	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: 1. no lesions evident; 2. minor mucosal and blood vessel lesions; 3. major blood vessel lesions, and; 4. major mucosal and blood vessel lesions,

Trial Locations

Locations (1)

American Health Research; 🇺🇸 Charlotte, North Carolina, United States