NCT01284361

Comparison of Two Intermittent Urinary Catheters

User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Hollister Incorporated · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Individual participation will consist of approximately 1 week of product use. The null hypothesis to be tested is there no difference between catheters.

Detailed description

1. is male and at least 18 years of age. 2. is self-catheterizing at least 3 times a day. 3. has been performing catheterizations for at least 2 months. 4. is wheelchair bound. 5. is able to use a size 12 or 14 French straight catheter. 6. is willing and able to follow the study protocol and Investigator's instructions. 7. is in the opinion of the Investigator, qualified to participate.

Conditions

• Urinary Retention

Interventions

Type	Name	Description
DEVICE	30 cm Intermittent Catheter	Randomized cross-over
DEVICE	40 cm Intermittent Catheter	randomized cross-over

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-01-27
• Last updated: 2017-02-01
• Results posted: 2016-12-01

Locations

4 sites across 1 country: United States