Comparative Study of Two Different Urine Catheters.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coloplast A/S
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Discomfort Measured on the Visual Analog Scale (VAS)
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.
Detailed Description
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.
Healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.
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,
- •Neg. urine multistix
Exclusion Criteria
- •Abnormalities,
- •diseases or surgical procedures performed in the lower urinary-tract
Arms & Interventions
Monza
nonCE marked intermittent catheter
Intervention: Intermittent catheter CP063CC (Device)
control
SpeediCath coated catheter
Intervention: Intermittent catheter CP063CC (Device)
control
SpeediCath coated catheter
Intervention: SpeediCath (Device)
Outcomes
Primary Outcomes
Discomfort Measured on the Visual Analog Scale (VAS)
Time Frame: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).
Secondary Outcomes
- Irritation During Voiding After Catheterization(10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1)
- Ease of Use Measured on a 5 Point Scale: Insertion Effort(10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1)
- Ease of Use Measured on a 5 Point Scale: Withdrawal Effort(10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1)
- Visible Blood(10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1)
- Haematuria(2 hours after catheterisation at visits 1 and 2)