Comparison of Two Intermittent Urinary Catheters
This study has been completed.
Sponsor:
Hollister Incorporated
Information provided by (Responsible Party):
Hollister Incorporated
ClinicalTrials.gov Identifier:
NCT01284361
First received: January 21, 2011
Last updated: February 19, 2013
Last verified: July 2012
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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.
| Condition | Intervention |
|---|---|
|
Urinary Retention |
Device: test and control intermittent urinary catheters |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter |
Further study details as provided by Hollister Incorporated:
Primary Outcome Measures:
- preference for length [ Time Frame: 1 week ] [ Designated as safety issue: No ]proportion of subjects favoring one length over the other
Secondary Outcome Measures:
- appreciation of user characteristics [ Time Frame: 1 week ] [ Designated as safety issue: No ]ease of insertion, removal, and control while catheterizing rated using a 5 point Likert scale
| Enrollment: | 91 |
| Study Start Date: | October 2010 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: test |
Device: test and control intermittent urinary catheters
randomized cross-over
|
| Active Comparator: control |
Device: test and control intermittent urinary catheters
randomized cross-over
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284361
Locations
| United States, Georgia | |
| Shepherd Center and Crawford Research Institute | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Mark Drug Medical Supply | |
| Wheeling, Illinois, United States | |
| United States, Missouri | |
| Restored Images | |
| Kansas City, Missouri, United States | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States | |
Sponsors and Collaborators
Hollister Incorporated
Investigators
| Study Director: | Rita Kaurs, MSHSA MT NMT | Hollister Incorporated |
More Information
No publications provided
| Responsible Party: | Hollister Incorporated |
| ClinicalTrials.gov Identifier: | NCT01284361 History of Changes |
| Other Study ID Numbers: | 4875-I |
| Study First Received: | January 21, 2011 |
| Last Updated: | February 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Hollister Incorporated:
|
intermittent catheter preference |
Additional relevant MeSH terms:
|
Urinary Retention Urination Disorders Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013