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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 cm Intermittent Catheter | Experimental | Intervention was the test of a 30 cm catheter compared to standard commercial 40 cm catheter in a cross-over design. |
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| 40 cm Intermittent Catheter | Active Comparator | Active comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30 cm Intermittent Catheter | Device | Randomized cross-over |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants | Percentage of participants that preferred the 40 cm catheter | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Ease of Use Characteristics | Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the "top" two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita Kaurs, MSHSA MT NMT | Hollister Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shepherd Center and Crawford Research Institute | Atlanta | Georgia | 30309-1465 | United States | ||
| Mark Drug Medical Supply |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23896665 | Result | 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. | |
| 34699062 | Derived | 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. |
| Label | URL |
|---|---|
| Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization | View source |
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Published in Spinal Cord (2013) 51, 772-775
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Recruitment period: October 10, 2010 - July 21 , 2011 types of locations: private vendor, public rehabilitation center, university
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| ID | Title | Description |
|---|---|---|
| FG000 | Control and Test Crossover | test and control intermittent urinary catheters : randomized cross-over |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Each subject was given 10 Control catheters and 10 Test catheters to be used consecutively until all 20 catheters were used. Subjects used either the Test catheters (A) first and then the Control catheters (B) or vice versa. Subjects completed questionnaire after using each catheter and a preference questionnaire after all catheters were used.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control and Test Crossover | test and control intermittent urinary catheters : randomized cross-over |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants | Percentage of participants that preferred the 40 cm catheter | Posted | Number | percentage of participants | 1 week |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control 40 cm Catheter | Commercial 40 cm gel lubricated catheter |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding | Renal and urinary disorders | Non-systematic Assessment | reported mild urethral bleeding after using one 30 cm catheter |
Male catheter users only in USA only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Malford Cullum PhD/Sr Clin Res Scientist | Hollister Incorporated | 847-918-3975 | malford.cullum@hollister.com |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 40 cm Intermittent Catheter | Device | randomized cross-over |
|
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| 1 week |
| Wheeling |
| Illinois |
| 60090 |
| United States |
| Restored Images | Kansas City | Missouri | 64119 | United States |
| Vanderbilt University | Nashville | Tennessee | 37235 | United States |
| Lost to Follow-up |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Assessment of Ease of Use Characteristics | Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the "top" two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree. | 82 self-catheterizing wheelchair-using men | Posted | Number | percentage of participants | 1 week |
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|
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| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | Test 30 cm Catheter | Test 30 cm gel lubricated cather similar in all aspects except 10 cm shorter length as control catheter | 0 | 91 | 2 | 91 |
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| discomfort | Renal and urinary disorders | Non-systematic Assessment | reported mild pain when he used all ten 30 cm catheters |
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Variable restriction depends on site.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Ease of Catheter Control Upon Urethral Insertion |
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| Confidence of Complete Bladder Drainage |
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| Ease of Draining into Receptacle |
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| Ease of Connecting Urine Bag |
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