NCT01292941

Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)

Detailed 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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	Intermittent catheterisation	Speedicath, Intermittent catheterisation
DEVICE	NonCE marked intermittent catheter/red	Paris, Intermittent catheterisation
DEVICE	NonCE marked intermittent catheter/green	Paris, Intermittent catheter
DEVICE	NonCE marked intermittent catheter/blue	Paris, Intermittent catheter

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-02-10
• Last updated: 2015-08-07

Locations

1 site across 1 country: Denmark