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

Coloplast

Status: Completed

Conditions: Incontinence, Urinary

Treatments: Device: Coloplast Speedicath; Device: Coloplast Test Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02965066

CP269

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 2 patient groups

First Coloplast Test catheter; then Speedicath catheter

Experimental group

Description:

The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter

Treatment:

Device: Coloplast Speedicath

Device: Coloplast Test Catheter

First Speedicath catheter; then Coloplast Test catheter

Experimental group

Description:

The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter

Treatment:

Device: Coloplast Speedicath

Device: Coloplast Test Catheter