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

Urinary Incontinence Clinical Trial

— CP341  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05224544
• Other study ID #: CP341
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: March 31, 2022

Study information

• Verified date: December 2021
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 110 Years

Eligibility

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 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

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• Nautilus Catheter
The test product is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
• Comparator
The comparator is a urinary catheter for bladder drainage through the urethra.

Locations

Country	Name	City	State
United States	American Health Research	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in appearance of the bladder mucosa (pre- and post-catheterization) (?), rated on a 4-point scale following visit 2 (Day 2).	Change in appearance of the bladder mucosa (pre- and post-catheterization) (?), rated on a 4-point scale following visit 2 (Day 2).; 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,	Day 2