Comparison of Two Intermittent Urinary Catheters

NCT ID: NCT01284361

Last Updated: 2017-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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1. is male and at least 18 years of age.
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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Urinary Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

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.

Group Type EXPERIMENTAL

30 cm Intermittent Catheter

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

40 cm Intermittent Catheter

Intervention Type DEVICE

randomized cross-over

Interventions

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30 cm Intermittent Catheter

Randomized cross-over

Intervention Type DEVICE

40 cm Intermittent Catheter

randomized cross-over

Intervention Type DEVICE

Other Intervention Names

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Apogee Intermittent Catheter Apogee Intermittent Catheter

Eligibility Criteria

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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 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hollister Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Mark Drug Medical Supply

Wheeling, Illinois, United States

Site Status

Restored Images

Kansas City, Missouri, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

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.

Reference Type RESULT
PMID: 23896665 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34699062 (View on PubMed)

Related Links

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http://www.nature.com/sc/journal/v51/n10/full/sc201376a.html

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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