Comparison of Two Intermittent Urinary Catheters
- Conditions
- Urinary Retention
- Interventions
- Device: 30 cm Intermittent CatheterDevice: 40 cm Intermittent Catheter
- Registration Number
- NCT01284361
- Lead Sponsor
- Hollister Incorporated
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 91
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 30 cm Intermittent Catheter 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. 40 cm Intermittent Catheter 40 cm Intermittent Catheter Active comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design.
- Primary Outcome Measures
Name Time Method Percentage of Participants 1 week Percentage of participants that preferred the 40 cm catheter
- Secondary Outcome Measures
Name Time Method Assessment of Ease of Use Characteristics 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.
Trial Locations
- Locations (4)
Mark Drug Medical Supply
🇺🇸Wheeling, Illinois, United States
Shepherd Center and Crawford Research Institute
🇺🇸Atlanta, Georgia, United States
Restored Images
🇺🇸Kansas City, Missouri, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States