Test Catheter Pilot Study in Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Discomfort
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years or older
- •Signed informed consent
- •Negative urine multistix
Exclusion Criteria
- •Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Arms & Interventions
Group A
SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2
Intervention: SpeediCath Compact Male (Device)
Group A
SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2
Intervention: Speedicath (Device)
Group B
SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2
Intervention: SpeediCath Compact Male (Device)
Group B
SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2
Intervention: Speedicath (Device)
Outcomes
Primary Outcomes
Discomfort
Time Frame: After each catheterisation
Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)
Secondary Outcomes
- Handling(After each catheterisation)
- Preference(At study termination)
- Haematuria(After each catheterisation)