Trial Outcomes & Findings for Consumer Evaluation of Intermittent Catheter Product Modifications (NCT NCT04619992)
NCT ID: NCT04619992
Last Updated: 2022-08-03
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
62 participants
Primary outcome timeframe
10 days
Results posted on
2022-08-03
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
7
|
|
Overall Study
COMPLETED
|
54
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
n=54 Participants
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
|
New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
n=7 Participants
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
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=61 Participants
|
|
Age, Customized
18-29 years
|
8 Participants
n=54 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=61 Participants
|
|
Age, Customized
30-39 years
|
12 Participants
n=54 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=61 Participants
|
|
Age, Customized
40-49 years
|
11 Participants
n=54 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=61 Participants
|
|
Age, Customized
50-59 years
|
10 Participants
n=54 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=61 Participants
|
|
Age, Customized
60-69 years
|
9 Participants
n=54 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=61 Participants
|
|
Age, Customized
70-79 years
|
3 Participants
n=54 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=61 Participants
|
|
Age, Customized
80-89 years
|
1 Participants
n=54 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=61 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=54 Participants
|
7 Participants
n=7 Participants
|
61 Participants
n=61 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
54 participants
n=54 Participants
|
7 participants
n=7 Participants
|
61 participants
n=61 Participants
|
PRIMARY outcome
Timeframe: 10 daysUsers 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.
Outcome measures
| Measure |
Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
n=54 Participants
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
|
New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
n=7 Participants
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
|
|---|---|---|
|
Acceptability of Test Hydrophilic Intermittent Catheter
'Disagree' or 'Strongly disagree'
|
5 Participants
|
1 Participants
|
|
Acceptability of Test Hydrophilic Intermittent Catheter
'Strongly agree' or 'Agree'
|
45 Participants
|
4 Participants
|
|
Acceptability of Test Hydrophilic Intermittent Catheter
Neither agree nor disagree
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 10 daysUsers 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.
Outcome measures
| Measure |
Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
n=54 Participants
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
|
New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
n=7 Participants
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
|
|---|---|---|
|
Preference of Test Hydrophilic Intermittent Catheter
'Strongly agree' or 'Agree'
|
35 Participants
|
4 Participants
|
|
Preference of Test Hydrophilic Intermittent Catheter
Neither agree nor disagree
|
11 Participants
|
2 Participants
|
|
Preference of Test Hydrophilic Intermittent Catheter
'Disagree' or 'Strongly disagree'
|
8 Participants
|
1 Participants
|
Adverse Events
Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Current Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
n=54 participants at risk
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
|
New Users of Hollister Standard With Tip Hydrophilic Intermittent Catheters
n=7 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Potential viral infection
|
1.9%
1/54 • Number of events 1 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
0.00%
0/7 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
|
Surgical and medical procedures
Ankle surgery
|
1.9%
1/54 • Number of events 1 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
0.00%
0/7 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
|
Gastrointestinal disorders
Gastrointestinal discomfort
|
1.9%
1/54 • Number of events 1 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
0.00%
0/7 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
|
Infections and infestations
Urinary Tract Infection
|
1.9%
1/54 • Number of events 1 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
0.00%
0/7 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
|
Product Issues
Urethral discomfort
|
0.00%
0/54 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
14.3%
1/7 • Number of events 1 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
|
Renal and urinary disorders
Cloudy urine
|
1.9%
1/54 • Number of events 1 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
0.00%
0/7 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
|
Renal and urinary disorders
Reduced urine flow and hip spasticity
|
1.9%
1/54 • Number of events 1 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
0.00%
0/7 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
|
Renal and urinary disorders
Potential urethral narrowing
|
1.9%
1/54 • Number of events 1 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
0.00%
0/7 • Adverse events were monitored over the duration of the study (October 2020 to August 2021), an average of 12 days per subject.
|
Additional Information
Director of Global Clinical Affairs
Hollister Incorporated
Phone: +1 224-206-2857
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place