Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Pain
Study Overview
Brief Summary
The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Have given written informed consent and signed letter of authority
- •Be at least 18 years of age and have full legal capacity
- •Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
- •Have a negative urine multistix - erythrocytes (Microscopic haematuria)
- •Have a negative urine multistix:
- •Leukocytes
- •Nitrite Or if positive, subsequent negative for bacterial growth in urine culture
Exclusion Criteria
- •Abnormalities, diseases or surgical procedures performed in the lower urinary tract
- •Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
- •Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
- •Known hypersensitivity toward any of the test products -
Arms & Interventions
First Coloplast Test catheter; then Speedicath catheter
The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter
Intervention: Coloplast Test Catheter (Device)
First Coloplast Test catheter; then Speedicath catheter
The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter
Intervention: Coloplast Speedicath (Device)
First Speedicath catheter; then Coloplast Test catheter
The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter
Intervention: Coloplast Test Catheter (Device)
First Speedicath catheter; then Coloplast Test catheter
The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter
Intervention: Coloplast Speedicath (Device)
Outcomes
Primary Outcomes
Pain
Time Frame: 1 day
The VAS scale is used to measure the pain experienced by the subjects at catheterisation
Secondary Outcomes
No secondary outcomes reported