Urinary Retention
Conditions
Keywords
intermittent catheter, preference
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.
Interventions
DEVICE30 cm Intermittent Catheter
Randomized cross-over
DEVICE40 cm Intermittent Catheter
randomized cross-over
Sponsors
Hollister Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants | 1 week | Percentage of participants that preferred the 40 cm catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: October 10, 2010 - July 21 , 2011 types of locations: private vendor, public rehabilitation center, university
Participants by arm
| Arm | Count |
|---|---|
| Control and Test Crossover test and control intermittent urinary catheters : randomized cross-over | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Control and Test Crossover |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 82 Participants |
| Age, Continuous | 38.3 years STANDARD_DEVIATION 11.7 |
| Gender Female | 0 Participants |
| Gender Male | 82 Participants |
| Region of Enrollment United States | 82 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 91 | 2 / 91 |
| serious Total, serious adverse events | 0 / 91 | 0 / 91 |
Outcome results
Primary
Percentage of Participants
Percentage of participants that preferred the 40 cm catheter
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control and Test Crossover | Percentage of Participants | 91.5 percentage of participants |
Comparison: The sample size of 81 subjects provides a 10.8% margin of error.95% CI: [84.5, 97.5]
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.
Time frame: 1 week
Population: 82 self-catheterizing wheelchair-using men
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control and Test Crossover | Assessment of Ease of Use Characteristics | Ease of insertion | 84.65 percentage of participants |
| Control and Test Crossover | Assessment of Ease of Use Characteristics | Ease of Draining into Receptacle | 87.00 percentage of participants |
| Control and Test Crossover | Assessment of Ease of Use Characteristics | Ease of Removal | 94.85 percentage of participants |
| Control and Test Crossover | Assessment of Ease of Use Characteristics | Ease of Catheter Control Upon Urethral Insertion | 86.48 percentage of participants |
| Control and Test Crossover | Assessment of Ease of Use Characteristics | Ease of Connecting Urine Bag | 35.68 percentage of participants |
| Control and Test Crossover | Assessment of Ease of Use Characteristics | Confidence of Complete Bladder Drainage | 84.15 percentage of participants |
| Test 30 cm Catheter | Assessment of Ease of Use Characteristics | Ease of Connecting Urine Bag | 31.49 percentage of participants |
| Test 30 cm Catheter | Assessment of Ease of Use Characteristics | Ease of Catheter Control Upon Urethral Insertion | 72.19 percentage of participants |
| Test 30 cm Catheter | Assessment of Ease of Use Characteristics | Confidence of Complete Bladder Drainage | 45.80 percentage of participants |
| Test 30 cm Catheter | Assessment of Ease of Use Characteristics | Ease of Draining into Receptacle | 58.02 percentage of participants |
| Test 30 cm Catheter | Assessment of Ease of Use Characteristics | Ease of insertion | 67.78 percentage of participants |
| Test 30 cm Catheter | Assessment of Ease of Use Characteristics | Ease of Removal | 86.34 percentage of participants |