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Comparison of Two Intermittent Urinary Catheters

NCT01284361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2017-02-01

Study results available
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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.

Conditions

  • Urinary Retention

Interventions

DEVICE

30 cm Intermittent Catheter

Randomized cross-over

DEVICE

40 cm Intermittent Catheter

randomized cross-over

Sponsors & Collaborators

  • Hollister Incorporated

    lead INDUSTRY

Principal Investigators

  • Rita Kaurs, MSHSA MT NMT · Hollister Incorporated

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01284361 on ClinicalTrials.gov