Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
Status and phase
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Details and patient eligibility
About
To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)
Full description
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat 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.
55 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.
Sex
Ages
Volunteers
Inclusion criteria
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• ≥18 years
- Male
- Signed informed consent
- Negative urine stix (erythrocytes, leucocytes and nitrite)
Exclusion criteria
- • Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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