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

NCT ID: NCT02965105

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2016-12-31

Brief Summary

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

Conditions

Incontinence, Urinary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

First Coloplast Test Catheter; then Speedicath

The subjects allocated to this arm first test Coloplast Test Catheter and then after cross over test the comparator Speedicath Catheter

Group Type: EXPERIMENTAL

Coloplast Test Catheter

Intervention Type: DEVICE

This is a newly developed intermittent catheter

Speedicath

Intervention Type: DEVICE

This is a marketed Catheter which is used as comparator

First Speedicath; then Coloplast Test Catheter

The subjects allocated to this arm first test Speedicath Catheter and then after cross over test Coloplast Test Catheter

Group Type: EXPERIMENTAL

Coloplast Test Catheter

Intervention Type: DEVICE

This is a newly developed intermittent catheter

Speedicath

Intervention Type: DEVICE

This is a marketed Catheter which is used as comparator

Interventions

Coloplast Test Catheter

This is a newly developed intermittent catheter

Intervention Type: DEVICE

Speedicath

This is a marketed Catheter which is used as comparator

Intervention Type: DEVICE

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Bagi, MD

Role: PRINCIPAL_INVESTIGATOR

MD at the clinic for urology at Rigshospitalet

Locations

Rigshopsitalet

Copenhagen, København Ø, Denmark

Countries

Denmark

Other Identifiers

CP271

Identifier Type: -

Identifier Source: org_study_id