NCT01048541

Bladder Scan of Residual Urine With New Catheter

A Non-Inferiority Bladder Scan Study to Investigate Residual Urine After Use of Intermittent Catheters in Male Subjects

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon. This length is defined by hospital standards although it is known that the male urethra has an approximate maximum length of 29 cmA new intermittent catheter developed by Coloplast A/S is a 30-cm-long sterile, ready-to-use, hydrophilic-coated male catheter. There is a lack of clinical data documenting that male ICs that are shorter and more or less flexible than standard catheters can sufficiently empty the bladder of male subjects. This will be tested using ultrasound to measure residual urine in the bladder following catheterisation with new product and standard length catheter.

Detailed description

See brief summary

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Test Catheter - SpeediCath Compact Male	Compact catheter for intermittent catheterisation
DEVICE	SpeediCath	Catheter for intermittent catheterisation

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-01-13
• Last updated: 2012-09-03
• Results posted: 2012-09-03

Locations

1 site across 1 country: Germany