Study Results
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View full resultsBasic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2010-10-31
2011-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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30 cm Intermittent Catheter
Intervention was the test of a 30 cm catheter compared to standard commercial 40 cm catheter in a cross-over design.
30 cm Intermittent Catheter
Randomized cross-over
40 cm Intermittent Catheter
Active comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design.
40 cm Intermittent Catheter
randomized cross-over
Interventions
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30 cm Intermittent Catheter
Randomized cross-over
40 cm Intermittent Catheter
randomized cross-over
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Hollister Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Rita Kaurs, MSHSA MT NMT
Role: STUDY_DIRECTOR
Hollister Incorporated
Locations
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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
Countries
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References
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Costa JA, Menier M, Doran TJ, Kohler TS. Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization. Spinal Cord. 2013 Oct;51(10):772-5. doi: 10.1038/sc.2013.76. Epub 2013 Jul 30.
Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
Related Links
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Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization
Other Identifiers
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4875-I
Identifier Type: -
Identifier Source: org_study_id
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