Comparison of Two Intermittent Urinary Catheters

Completed · Not applicable

Conditions studied: Urinary Retention

In brief

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.

Key facts

Study ID

NCT01284361

Run by

Hollister Incorporated

People needed

91

Starts

2010-10-01

Expected to finish

2011-08-01

Last updated by the study team

2017-02-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• has cognitive impairments that preclude completion of study protocol
• cannot communicate as determined by the Investigator
• has an existing medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate or in the interpretation of the results
• has a symptomatic urinary tract infection determined by interview
• has a retracted penis
• has participated in a study during the previous 30 days involving catheterization
• has been diagnosed with an enlarged prostate
• has urethral strictures, false passages, or urethral obstruction

Where it is running

• Shepherd Center and Crawford Research Institute — Atlanta, Georgia, United States
• Mark Drug Medical Supply — Wheeling, Illinois, United States
• Restored Images — Kansas City, Missouri, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.