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Completed

NCT Number: NCT01284361

Comparison of Two Intermittent Urinary Catheters

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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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Shepherd Center and Crawford Research Institute, Atlanta, Georgia, United States

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About this study

  • 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.
  • is 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

30 cm Intermittent Catheter

Device

Randomized cross-over

Other names: Apogee Intermittent Catheter

40 cm Intermittent Catheter

Device

randomized cross-over

Other names: Apogee Intermittent Catheter

Primary outcomes

  1. Percentage of Participants

    Time frame: 1 week

    Percentage of participants that preferred the 40 cm catheter

Secondary outcomes

  1. Assessment of Ease of Use Characteristics

    Time frame: 1 week

    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.

Sponsors and collaborators

Lead sponsor

Hollister Incorporated

Industry

Registry information

Official study title

User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2011
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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