Expired Study
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Kansas City, Missouri


Purpose:

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.


Criteria:

Inclusion Criteria: - 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/Charriere 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 Exclusion Criteria: - 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


NCT ID:

NCT01284361


Primary Contact:

Study Director
Rita Kaurs, MSHSA MT NMT
Hollister Incorporated


Backup Contact:

N/A


Location Contact:

Kansas City, Missouri
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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