Urinary Incontinence
Conditions
Keywords
Intermittent Catheterization
Brief summary
This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.
Interventions
DEVICECurrently marketed Hydrophillic Intermittent Catheter
Currently marketed Hollister standard with tip hydrophilic intermittent catheter
DEVICETest Hydrophilic Intermittent Catheter
Hollister standard with tip hydrophilic intermittent catheter with design enhancements
Sponsors
Hollister Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A. Inclusion Criteria for Arm 1 Subject who: 1. is male and at least 18 years of age 2. has been performing unassisted, self-catheterizations, with a Hollister standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month B.
Exclusion criteria
for Arm 1 Subject who: 1. is currently undergoing chemotherapy, radiation or steroid therapy 2. has a symptomatic urinary tract infection (UTI) 3. is currently using a coude intermittent catheter product to perform catheterization 4. performs non-urethral catheterization C. Inclusion Criteria for Arm 2 Subject who: 1. is male and at least 18 years of age 2. has been performing unassisted, self-catheterizations, with a non-standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month D.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Test Hydrophilic Intermittent Catheter | 10 days | Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter. |
| Preference of Test Hydrophilic Intermittent Catheter | 10 days | Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters Subjects in this arm are current users of Hollister standard with tip hydrophilic intermittent catheters.
Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements | 54 |
| New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters Subjects in this arm are new users of Hollister standard with tip hydrophilic intermittent catheters.
Currently marketed Hydrophillic Intermittent Catheter: Currently marketed Hollister standard with tip hydrophilic intermittent catheter
Test Hydrophilic Intermittent Catheter: Hollister standard with tip hydrophilic intermittent catheter with design enhancements | 7 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Total |
|---|---|---|---|
| Age, Customized 18-29 years | 8 Participants | 0 Participants | 8 Participants |
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 30-39 years | 12 Participants | 0 Participants | 12 Participants |
| Age, Customized 40-49 years | 11 Participants | 1 Participants | 12 Participants |
| Age, Customized 50-59 years | 10 Participants | 2 Participants | 12 Participants |
| Age, Customized 60-69 years | 9 Participants | 1 Participants | 10 Participants |
| Age, Customized 70-79 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Customized 80-89 years | 1 Participants | 0 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 54 participants | 7 participants | 61 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 54 Participants | 7 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 7 |
| other Total, other adverse events | 7 / 54 | 1 / 7 |
| serious Total, serious adverse events | 0 / 54 | 0 / 7 |
Outcome results
Primary
Acceptability of Test Hydrophilic Intermittent Catheter
Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter.
Time frame: 10 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Acceptability of Test Hydrophilic Intermittent Catheter | 'Strongly agree' or 'Agree' | 45 Participants |
| Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Acceptability of Test Hydrophilic Intermittent Catheter | Neither agree nor disagree | 4 Participants |
| Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Acceptability of Test Hydrophilic Intermittent Catheter | 'Disagree' or 'Strongly disagree' | 5 Participants |
| New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Acceptability of Test Hydrophilic Intermittent Catheter | 'Strongly agree' or 'Agree' | 4 Participants |
| New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Acceptability of Test Hydrophilic Intermittent Catheter | Neither agree nor disagree | 2 Participants |
| New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Acceptability of Test Hydrophilic Intermittent Catheter | 'Disagree' or 'Strongly disagree' | 1 Participants |
Primary
Preference of Test Hydrophilic Intermittent Catheter
Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter.
Time frame: 10 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Preference of Test Hydrophilic Intermittent Catheter | 'Strongly agree' or 'Agree' | 35 Participants |
| Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Preference of Test Hydrophilic Intermittent Catheter | Neither agree nor disagree | 11 Participants |
| Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Preference of Test Hydrophilic Intermittent Catheter | 'Disagree' or 'Strongly disagree' | 8 Participants |
| New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Preference of Test Hydrophilic Intermittent Catheter | 'Strongly agree' or 'Agree' | 4 Participants |
| New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Preference of Test Hydrophilic Intermittent Catheter | Neither agree nor disagree | 2 Participants |
| New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters | Preference of Test Hydrophilic Intermittent Catheter | 'Disagree' or 'Strongly disagree' | 1 Participants |