NCT01142115

Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers

Comparative Study of Two Different Urine Catheters.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	Intermittent catheter CP063CC	intermittent catheterisation
DEVICE	SpeediCath	intermittent catheterisation

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-06-11
• Last updated: 2011-10-07
• Results posted: 2011-08-09

Locations

1 site across 1 country: Denmark