Safety and Performance of a New Coating for Urinary Intermittent Catheters

Intermittent Urethral Catheterization Clinical Trial

Official title:

Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800903
• Other study ID #: CP235
• Secondary ID: CP235
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: April 2013

Study information

• Verified date: August 2020
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have given written informed consent and signed letter of authority

2. Be at least 18 years of age and have full legal capacity

3. Be a male

4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits

Exclusion Criteria:

1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract

2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)

3. Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)

4. Known hypersensitivity toward any of the test products -

Related Conditions & MeSH terms

• Intermittent Urethral Catheterization

Intervention

Device:
• ZN-D catheter
ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
• ZN-C catheter
ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
• SpeediCath catheter
The Speedicath cathere is CE-marked and commercially available.

Locations

Country	Name	City	State
Denmark	Department of Urology	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Discomfort During Catheterization	Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.	1 day