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
• 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

• Enuresis
• Incontinence, Urinary
• Urinary Incontinence

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