Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 18 years or older
- Male
- signed informed Consent,
- Neg. urine multistix
Exclusion criteria
- Abnormalities,
- diseases or surgical procedures performed in the lower urinary-tract
Trial design
Primary purpose
Allocation
Interventional model
Masking
41 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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