Comparison of Two Intermittent Urinary Catheters
User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter
1 other identifier
interventional
91
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2010
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 21, 2011
CompletedFirst Posted
Study publicly available on registry
January 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
December 1, 2016
CompletedFebruary 1, 2017
December 1, 2016
10 months
January 21, 2011
December 2, 2013
December 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants
Percentage of participants that preferred the 40 cm catheter
1 week
Secondary Outcomes (1)
Assessment of Ease of Use Characteristics
1 week
Study Arms (2)
30 cm Intermittent Catheter
EXPERIMENTALIntervention was the test of a 30 cm catheter compared to standard commercial 40 cm catheter in a cross-over design.
40 cm Intermittent Catheter
ACTIVE COMPARATORActive comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design.
Interventions
Randomized cross-over
randomized cross-over
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Shepherd Center and Crawford Research Institute
Atlanta, Georgia, 30309-1465, United States
Mark Drug Medical Supply
Wheeling, Illinois, 60090, United States
Restored Images
Kansas City, Missouri, 64119, United States
Vanderbilt University
Nashville, Tennessee, 37235, United States
Related Publications (2)
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.
PMID: 23896665RESULTPrieto 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.
PMID: 34699062DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Male catheter users only in USA only.
Results Point of Contact
- Title
- Malford Cullum PhD/Sr Clin Res Scientist
- Organization
- Hollister Incorporated
Study Officials
- STUDY DIRECTOR
Rita Kaurs, MSHSA MT NMT
Hollister Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2011
First Posted
January 27, 2011
Study Start
October 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
February 1, 2017
Results First Posted
December 1, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share
Published in Spinal Cord (2013) 51, 772-775