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NCT02965066 Clinical Trial

Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers

Incontinence, Urinary Clinical Trial

Official title:
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02965066
Other study ID # CP269
Secondary ID
Status Completed
Phase N/A
First received November 11, 2016
Last updated November 11, 2016
Start date September 2016
Est. completion date November 2016

Study information
Verified date November 2016
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date November 2016
Est. primary completion date November 2016
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

5. Have a negative urine multistix - erythrocytes (Microscopic haematuria)

6. Have a negative urine multistix:

- Leukocytes

- Nitrite Or if positive, subsequent negative for bacterial growth in urine culture

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 clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation

4. Known hypersensitivity toward any of the test products -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Device:
• Coloplast Test Catheter
Newly developed intermittent catheter
• Coloplast Speedicath
Marketed Coloplast Speedicath catheter

Locations
Country Name City State
Denmark Rigshospitalet Coppenhagen

Sponsors (1)
Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain The VAS scale is used to measure the pain experienced by the subjects at catheterisation 1 day Yes
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